Citations

Background: Prophylactic antimicrobials for pediatric patients requiring extracorporeal membrane oxygenation (ECMO) support are not well delineated; there are no consistent guidelines nationally or internationally. We analyzed antimicrobial use before and after implementing a narrow-spectra ECMO antimicrobial prophylaxis protocol intended to standardize prophylaxis by risk related to ECMO type and configuration. Methods: This retrospective, single-center study included children under 18 years old requiring ECMO between May 2018 and December 2021. Medical and cardiac surgical patients requiring open-chested (central) or peripheral veno-venous or veno-arterial ECMO were included. We evaluated the impact of an ECMO antimicrobial prophylaxis protocol by comparing the appropriateness of antimicrobial use as well as nosocomial infections in the pre versus post protocol. Results: Our study included 55 children with 58 individual ECMO episodes. More than 50% of the patients were open-chested during ECMO support, and the majority of ECMO support was veno-arterial. In the post protocol period, patients were 4 times as likely to have appropriate antimicrobial prescribing (Odds ratio 4.4; 95% confidence interval: 1.1–19; P = 0.036), including both prophylactic (per protocol) and therapeutic (chart documentation of an infection with appropriate therapeutic antimicrobials, including drug and duration). There was no difference in the odds of nosocomial infection occurring during ECMO pre protocol versus post protocol (pre vs. post protocol, P = 0.71 for invasive infections, P = 0.73 for all infections including potential colonization). Conclusions: After implementation of a standardized narrow-spectra ECMO antimicrobial prophylaxis protocol, we observed an increase in appropriate and standardized antimicrobial prescribing without concomitant increase in nosocomial infections.

PURPOSE The likelihood of finding a human leukocyte antigen (HLA)–matched unrelated donor (MUD) for hematopoietic cell transplantation can be predicted using a donor search prognosis score. Patients without a MUD may use alternative donors (haploidentical related, mismatched unrelated, or umbilical cord blood). METHODS This multicenter biological assignment trial was conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 1702). Eligibility criteria were broad to mirror clinical practice. The primary end point was 2-year survival from evaluability and compared between those Very Likely (>90%) and Very Unlikely (<10%) to find a MUD. All other patients, Less Likely to find a MUD, were enrolled in an observational arm. Transplant outcomes were compared for all three groups. RESULTS A total of 1,751 evaluable patients at 47 centers were Very Likely (54.7%), Less Likely (29.5%), and Very Unlikely (15.8%) to identify a MUD. Survival did not differ in univariate (hazard ratio [HR], 1.00 [95% CI, 0.82 to 1.21]; P = .98) or multivariate (HR, 1.07 [95% CI, 0.86 to 1.33]; P = .56) analyses between the Very Unlikely and Very Likely groups, measured through 2 years from the beginning of a search for a MUD or alternative donor. Of the transplanted patients (n = 1,179), MUD was used for 94% of the Very Likely, 38% of Less Likely, and 9% of Very Unlikely patients. Multivariate analyses showed no differences in relapse, treatment-related mortality, disease-free survival, and acute and chronic graft-versus-host diseases for the three search prognosis groups after transplantation. CONCLUSION Using a donor search prognosis strategy to prioritize an alternative donor for patients Very Unlikely to find a MUD resulted in survival and transplant outcomes that were not statistically different compared with those Very Likely to find a MUD.

Abstract Although follicular lymphoma (FL) typically follows an indolent course, patients with FL who experience early events, such as transformation or progression, have increased risk of death related to lymphoma. The FL24Cx is an algorithm based on a 45-target gene expression profiling (GEP) assay, which was developed and trained using 265 formalin-fixed, paraffin-embedded tissue samples on a reliable platform to predict, at the time of diagnosis, whether a patient will experience an event within 24 months. The modeling also confirmed and relied upon previously reported synergy between immune response (IR) gene expression signatures IR1 and IR2. Once locked, the 5-factor logistic regression FL24Cx model was independently validated in a retrospectively assessed cohort of 232 patients from 2 immunochemotherapy-treated arms of SWOG Cancer Research Network S0016 phase 3 clinical trial, in which it assigned 169 patients to the low-risk group with 29 events before 24 months (17.2%) and 63 patients to the high-risk group with 24 events before 24 months (38.1%). The relative risk of an event within 24 months after registration among patients who were classified into the high-risk group relative to patients who were classified into the low-risk group was 2.2 (95% confidence interval, 1.41 to 3.51). An up-front GEP biomarker, such as the FL24Cx, rigorously validated in a clinical laboratory and with a clinically relevant turnaround time, could identify and steer enrollment of patients at high risk for early events in clinical trials, thus enabling timely interpretation of such trials and increasing the pace of innovation.

Abstract Measurable residual disease (MRD) assessment by flow cytometry (FC) plays an essential role in prognosis and therapy escalation of B-cell acute lymphoblastic leukemia (B-ALL). However, the high degree of expertise and manual analysis time required limits the availability of this assay. To overcome this limitation, we developed a data-enhancing artificial intelligence (AI) pipeline that accelerates and simplifies MRD analysis. Unaltered FC files from 171 B-ALL MRD-positive and 89 MRD-negative cases were processed through an AI pipeline trained with 31 expert-gated negative controls. Cluster-informed downsampling reduced FC files from 1.2 million to 155 884 cells per case, on average, (87% cellularity reduction), whereas preserving small MRD populations (median, 100% retention for MRD of &lt;1%) and allowing for true percentage MRD estimates using a correction factor. A deep neural network cell classifier automatically identified normal hematopoietic subsets (macro-averaged F1 score of 0.86); and an AI measure of anomaly discriminated B-ALL from benign mononuclear (area under the curve [AUC] of 0.98) or B-lymphoid cells (AUC of 0.94). Manual analysis of AI-enhanced files was completed in only 1.01 minutes per case, on average (standard deviation of ±0.57); with 100% positive agreement with conventional analysis (for MRD of ≥0.01%), 100% negative agreement, and excellent quantitative correlation (R2 = 0.92). Our cloud-based AI-enhancement solution accelerates B-ALL MRD identification without compromising test performance and has the potential of facilitating B-ALL MRD analysis by more clinical laboratories.

Abstract Background: Alaska Native people are committed to increasing colorectal cancer (CRC) screening to reduce the high rate of CRC in this population. We conducted a community-level cluster randomized controlled trial (RCT) to evaluate the impact of multi-target stool DNA test introduction (mt-sDNA; Cologuard® Exact Sciences, Madison WI) on CRC screening in southwest Alaska Native communities using a mt-sDNA pre-processing lab in Anchorage, Alaska. Methods: A total of 32 rural/remote Alaska Native communities were evenly randomized to either high intensity patient navigation or medium intensity mailed health education compared to 14 communities receiving standard of care (screening recommendations at health care visits). The intervention was conducted from April 2021-February 2023. Outcome measures included CRC screening completion within 12 months and method used (mt-sDNA vs colonoscopy). Results: A total of 2032 Alaska Native participants (mean [SD] age, 56 [8.4] years; 817 women [40%]) were enrolled: 587 participants randomized to usual care, 696 participants randomized to the mailed education arm, and 749 participants randomized to the patient navigation arm. The mt-sDNA test was significantly preferred over colonoscopy by both mailed education participants (68%) and patient navigation participants (71%) (p&lt;0.01). Mt-sDNA was somewhat more preferred by older participants ages 65-75 (79%) vs younger participants ages 45-54 (64%). Both men (71%) and women (68%) significantly preferred mt-sDNA compared with colonoscopy (p&lt;0.01). Overall, 38% of those in the patient navigation intervention completed screening compared with 33% in the mailed education intervention and 10% in the usual care arm. No significant differences were observed in mt-sDNA completion between the patient navigation arm (154 participants [40%]) and the mailed education arm (100 participants [36%]) (p= 0.34). Colonoscopy completion (not including follow-up colonoscopies after abnormal stool tests) was higher in both the patient navigation arm (112 participants [44%]) and the mailed education arm (87 participants [43%]) compared with usual care (38 participants [14%]). Over 61% of kits sent to participants were completed and returned, however, 38% of the kits were not able to be processed, primarily because of mail transit time exceeding the manufacturer’s collection-to-processing limitation of 72 hrs. Conclusions: In this RCT among Alaska Native peoples who were not up to date with CRC screening recommendations, both a mailed education intervention and a patient navigator facilitated intervention were effective at increasing CRC screening compared with usual care. Participants overwhelmingly preferred mt-sDNA for screening but limitations in getting samples to the lab in time for analysis meant that about one-third of mt-sDNA samples were unable to be processed. These findings show that screening outreach and mt-sDNA use can substantially increase CRC screening, but shipping and weather issues remain to be addressed for expanding use of mt-sDNA in rural/remote Alaskan communities. Citation Format: Diana Redwood, Christie Flanagan, Lauren Jeffries, Peter Holck, Danika Bailie, Christine Desnoyers, Joseph Klejka, Lila Rutten, John Kisiel. Increase in colorectal cancer screening among rural and remote Alaska Native peoples using the multi-target stool DNA: A randomized controlled trial [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr A148.

Abstract Introduction. Understanding the unique social and environmental contexts of communities is essential for designing effective, locally tailored cancer intervention strategies. This study aimed to identify key findings from a comprehensive, multifaceted, cancer-focused needs assessment conducted across three U.S. regions, offering insights into the social, behavioral, and structural barriers that hinder cancer prevention and control, and informing regionally tailored interventions. Methods. This study focused on adult residents within the Mayo Clinic Comprehensive Cancer Center catchment areas, covering 75 counties across Arizona, Florida, and the Midwest (Minnesota, Wisconsin, and Iowa). Data was collected through collaborations with the University of Florida and Mayo Clinic Survey Research Centers, and the “Boots on the Ground" approach involving community health workers. Methods included phone calls, online submissions, and community outreach for an anonymous survey. Validated measures assessed healthcare access, lifestyle, social networks, neighborhood conditions, and discrimination. Descriptive analyses were conducted using valid responses. Non-responses and selections of “Prefer not to answer” were excluded from percentage calculations to ensure interpretive accuracy. Results. Involving 2,681 respondents, the data reveal consistent yet regionally nuanced barriers to cancer prevention. Health insurance coverage was relatively high across all regions—77.6% in Arizona, 85.5% in Florida, and 89.2% in the Midwest. Despite this, access to care remained limited. In Arizona, 22% of respondents could not afford to see a regular doctor, and 41.3% reported delays due to work or transportation. In Florida, 26.6% reported financial barriers to primary care, and nearly half (49.7%) experienced delays in receiving care. The Midwest showed fewer neighborhood safety concerns but still faced high rates of care delays (46.7%) and housing-related issues (42.6%). Neighborhood-level challenges were common. Housing-related problems were reported by 42.9% of respondents in Arizona, 54% in Florida, and 42.6% in the Midwest. Concerns about drug use were highest in Arizona (40%) but present across all regions. Health behavior risks were also widespread: 72–79% of respondents reported sleep difficulties, and many reported low physical activity, suboptimal sun protection, and routine alcohol use. Psychosocial stressors were prominent, with 51–65% of respondents reporting experiences of disrespect and 42–66% feeling unheard by healthcare providers. Conclusions. Despite relatively high rates of insurance coverage, communities across all regions face persistent challenges in accessing timely, affordable, and respectful healthcare. Coupled with neighborhood instability, adverse health behaviors, and psychosocial stressors, these barriers highlight the urgent need for regionally tailored strategies that strengthen both cancer prevention and care. Addressing these interconnected challenges at the community level is essential for promoting more equitable cancer outcomes. Citation Format: Tingyu Zou, Monica L. Albertie, Emelina Asto-Flores, Manisha Salinas, Farhia Omar, Adeline Abbenyi, Noreen Stephenson-Hubert, Nuwanthi Heendeniya, Kathleen Yost, Folakemi T. Odedina. Place, people, and prevention: Contextual drivers of cancer health equity in three US Regions [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr B031.

Abstract Introduction: The disproportionate prostate cancer (CaP) burden, which includes high mortality rates, is significantly attributed to the characteristics of the social determinants of the health status of the Black Male population. Designing targeted interventions to address poor health outcomes through a collaborative population-based approach could reduce CaP health disparities. The Community Living Lab (CoLLab) Learning Health System was developed to address ethnically sensitive, targeted approaches that will eliminate CaP health disparities among Black Men. This study assessed demographic factors and Knowledge on prostate cancer screening attitudes and research participation among black men. Method: The collab project employed a social ecological model to design intervention to address barriers to CaP screening and participation in clinical trials. A validated, pretested questionnaire was used to collect information on demographics, CaP knowledge, attitudes, testing, and a history of participation in research and clinical trials. Baseline data were collected from 3 American Legion posts (ALPs). The association between variables was evaluated using the Chi-square test. Results: Participants between 60-69 years were 28.38%, and those aged 40-49 were 12.16%. Most are US-born Black (89.8%), with others identifying as African-born Black (6.76%) and Caribbean-born Black (1.35%). Approximately 43.24% were retired, and 36.49% were working full-time. CaP knowledge was high in 43.9%, moderate in 46.6%, and low in 9.5%. Only 45% of the participants have undergone Prostate-Specific Antigen test, and 24.6% have had a Digital Rectal Examination. Reported past clinical trials and research participation were very low (9.38%). Participants with higher knowledge levels had higher information scores (p &lt; .0001), favored various research settings (p = 0.0008), had favorable attitudes towards CaP testing (p &lt; .0001), and were more likely to participate in research (p = 0.0117). Work status was found to impact CaP Knowledge (p = 0.0117). Participants with stronger beliefs about prostate cancer may have different attitudes toward testing (p = 0.0444). Age did not impact attitudes toward CaP testing (p = 0.4298). Conclusion: The knowledge of CaP was found to impact the attitudes, testing, and disposition of the participants towards research. The baseline data generated from the clinical study will curate insightful evidence that will create innovative approaches to prostate cancer education among males in Black communities. Citation Format: Opeyemi O. Bolajoko, Quincy A. Wimberly, Daniel W. Lee, Collisa Mahin, Michelle Fudge, Shaina E. Flynn, Arnold J. Merriweather, Trevanne R. Matthews Hew, Monica L. Albertie, Dery Greene, Wayne Ford, Toshiko Moultrie, Floyd B. Willis, Folakemi T. Odedina. Influence of demographic factors and knowledge on prostate cancer screening attitude and research participation among Black men [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr C138.

Abstract Introduction: This ongoing study investigates the impact of vitamin D deficiency on the immune response to prostate cancer (CaP) in Black patients and its potential contribution to CaP disparities. The study also evaluates differences in immune function, including p53 and CaP associated antibody levels, in Black men with localized versus metastatic CaP. Methodology: Eligible patients with a history of localized or metastatic CaP are enrolled following informed consent (in person or remote). At baseline, blood is collected for calcium and vitamin D3 levels, and for immune testing. Patients who participate in the screening portion of the trial and are found to have vitamin D3 levels &lt;30 ng/mL are prescribed oral vitamin D3 (2000 IU daily) and asked to record adherence in a medication diary. Follow-up includes a 4-week check-in and end-of-treatment labs at 8 weeks for calcium, vitamin D3 levels, and immune re-testing. Virtual consults occur after baseline and at 8 weeks. Quality of life is measured at baseline and EOT follow-up using the CDC HRQOL–4. The study began accruing patients in December 2021. In an attempt to accelerate patient accrual, the protocol was amended to become one of Mayo Clinic’s first fully decentralized clinical trials. Newly integrated components included at-home and community-based blood collection (outside of Mayo Clinic southern sites) and continued virtual engagement. These changes were designed to reduce barriers linked to social determinants of health (SDOH) and expand participation among medically underserved populations. This is a report on the impact of clinical trial DCT. Results: From December 2021 to September 2023 (pre-DCT), 24 patients were enrolled from 66 patients who participated in the screening portion for the trial (mean accrual: 1.09/month; SD: 1.15). Following the DCT amendment, enrollment rose to 102 patients from 213 screened (mean: 4.86/month; SD: 3.12) through June 2025. Of 126 enrolled patients, 119 (94.4%) returned medication diaries, with only 6 non-returns occurring post-DCT. QOL measures were completed by approximately 75% of participants. Importantly, 90 of 126 participants (71%) were enrolled from outside Jacksonville, FL or Scottsdale/Phoenix, AZ, indicating successful national expansion. A total of 111 patients failed the screening due to baseline vitamin D levels &gt;30 ng/ml. The total number of protocol deviations increased post-DCT (60 from 10/23–6/25 vs. 14 from 12/21–9/23), there was no change in the number of protocol deviations per enrolled patients. Minor documentation and study timeline deviations were the most common in both periods. Conclusions: The successful implementation of a fully decentralized model was associated with a marked increase in the accrual of underserved patients and allows the completion of critical clinical trials that address important cancer care disparities without impacting protocol integrity. Clinical trial DCT can potentially reduce SDOH-related barriers and improve representation of underserved populations in research. Citation Format: Sandra Casanova Leyva, Kim M. Barbel Johnson, Tufia Haddad, Lydia Mercado, Trevanne Matthews Hew, Cassandra Moore, Gerardo Colon-Otero, Devina Joshi, Roselyn Heduvor. Feasibility of an interventional clinical trial addressing prostate cancer disparities in Black men by decentralization (DCT): A potential solution to disparities in clinical trial participation [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr C064.

Abstract Introduction: Advances in treatment have led to significant increases in survival rates, with over 90% of men diagnosed with prostate cancer (CaP) living at least five years. However, surviving cancer and its treatment often weigh a hefty survivorship burden. Men from the at-risk, vulnerable populations have the greatest burden. This study aims to understand distress among Black CaP survivors (CaPS) who bear the heaviest CaP burden. Method: We conducted key informant interviews with Motivational Interviewing techniques to collect CaPS demographic information, medical history, and multilevel distress evaluation. Descriptive analyses were conducted using SAS. Results: A total of 22 CaPS (aged from 48 to 72) were involved in the study. The majority of CaPS were African American (90.9%) and were diagnosed with stage 2 (31.8%) or stage 3 (36.4%). Over half of them (68.2%) were treated by surgery; most CaPS (90.9%) experienced side effects from prostate cancer treatments. CaPS reported distress in the following domains: Emotional well-being (e.g., Feeling sad, depressed or anxious, mental health) – 40.9%, Death of someone very close to you (e.g., family) – 36.4%, Alcohol use in close family – 36.4%, Experiences of discrimination or racism – 36.4%, Healthcare costs and coverage (e.g., medication, medical services, copay, insurance premium) – 31.8%, Loneliness and isolation – 27.3%, Serious injury/illness in close family (e.g., being a caregiver) – 27.3%, Money and finance – 22.7%, Using telehealth (e.g., using a smartphone or tablet for telephone or over the computer, clinic visit, patient portal, completing online forms, virtual classes) – 22.7%, Marriage, romantic relationships – 22.7%. Discussion: Black CaP survivors (CaPS) who bear the heaviest CaP burden are considered a priority population for research and care. These CaPS identified that their psychological distress was related to both familial and socioeconomic issues. The most endorsed life-stresses included emotional wellbeing, experiences of discrimination/racism, loneliness and isolation, healthcare cost/finance, family health, personal relationship, and telehealth use. The distress data as measured by the life-stress scale are invaluable in better documenting and addressing distress in interventions responsive to specific priority communities. Our novel findings suggest the relevance of grief and loss for these men. 36% reported death of someone close, and 27% indicated distress due to loneliness and isolation. Though the sample size was small, the distress data obtained may inform the science and practice of whole-person survivorship that consider distress emphasizing emotional wellbeing. The study is ongoing, and this abstract presents preliminary results; further muti-variate analyses will be conducted for the conference presentation. Citation Format: Kimlin Ashing, Floyd Willis, Chris Williams, John Mccall, Gaole Song, Fornati Bedell, Cassandra Moore, Ewan Cobran, Che Ngufor, Timethia Bonner, Getachew Dagne, Arnold Merriweather, Ernie Kaninjing, Rotimi Oladapo, Roxana Dronca, Fullwood Dottington, Folakemi Odedina. Whole person survivorship: Multilevel distress in prostate cancer survivors from priority communities [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr A024.