Proposals to Advance Health Equity Research in Precision Medicine

As part of Foundation Medicine’s Advancing Inclusive Diagnostics initiative, we invite the oncology research community to submit applications for retrospective data collaborations focused on the intersection of cancer disparities and genomic testing.

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Expert Review Committee

Rachna T. Shroff, MD, MS, FASCO

Rachna T. Shroff, MD, MS, FASCO, is associate director of Clinical Investigations and co-leader of the Gastrointestinal Clinical Research Team at the University of Arizona Cancer Center (UACC). She also is a professor with tenure in the Department of Medicine, Chief of the Division of Hematology and Oncology, and Medical Director for the Oncology Service Line. Dr. Shroff also served as Associate Dean for Clinical and Translational Research for the University of Arizona College of Medicine – Tucson; 2021 – 2024. She came to UACC from MD Anderson Cancer Center in Houston, where she was on faculty from 2010-18 after completing her medical oncology fellowship there.

Kashyap Patel, MD

Kashyap Patel, MD is the CEO of Carolina Blood and Cancer Care Associates. Dr. Patel is a practicing medical oncologist, board certified in Hematology, Oncology, and Internal Medicine. He has published/presented over 120 papers. He is frequently interviewed and cited in mainstream newspapers including NY times, Washington Post, NPR just to name a few including on key issues like Covid 19, Healthcare disparities (CHD), value-based care. He is also frequently invited by WH team to opine of Cancer Moonshot program. He has been honored by the US Congress for his exceptional contribution to healthcare.

Aakash Desai, MBBS, MPH

Dr. Aakash Desai, MBBS, MPH, is an Assistant Professor of Medicine at O'Neal Cancer Center, University of Alabama Birmingham. Specializing in Thoracic Oncology,  phase 1 clinical trials, and drug development, his work focuses on evidence-based oncology, clinical trials, and improving cancer care quality. Dr. Desai has received numerous accolades, including the Conquer Cancer Foundation ASCO Young Investigator Award and International Association for the Study of Lung Cancer Early Career Award in 2021, multiple ASCO Merit Awards, and education awards at international conferences. He was also a patient education ambassador for the Cancer GRACE Foundation and most recently was awarded the Robert Winn CDA for Diversity in Clinical Trials.

Introduction and Scientific Rationale

It is well documented in the literature that each innovation in oncology takes approximately ten to fifteen years to reach all corners of the United States. Innovation such as next generation sequencing (NGS) represents a critical consideration in delivering precision medicine to people impacted by cancer. Disparities in testing have been documented, but many questions remain unanswered and worthy of additional research as the cancer community works to address historic inequities.


Foundation Medicine’s Advancing Inclusive Diagnostic Initiative, includes multiple dimensions, including a commitment to genomic and real-world outcomes research. Over 35 abstracts/manuscripts have been published to date and can be found here.


Foundation Medicine is deeply committed to collaborating with members of the oncology researchers community to advance the field, leveraging high quality real-word data sets, including the Foundation Medicine – Flatiron Health Clinico-Genomic Database (CGDB). With over 125,000 patient clinical records and outcomes linked to tumor genomic profiles, CGDB has the potential to answer questions otherwise challenging to evaluate using other available genomic data sets. Through this Request for Collaboration, we invite clinician-researchers to submit ideas where real-world data can potentially provide tangible, valuable insights resulting in immediate impact to the field of cancer health equity.

This RFC provides public notice. 
 

Purpose

The purpose of this RFC is to solicit collaborative research ideas focused on focused on the intersection of cancer disparities and genomic testing.

Support requests must be healthcare-related and consistent with therapeutic or technological area(s) in which Foundation Medicine, Inc is active. 
 

Approach to Collaborative Research

Foundation Medicine believes in harnessing the power of real-world data to contribute to the field by answering questions that are challenging to answer using other available data sets. Input from clinicians caring for people impacted by cancer with expertise in specific disease states results in high-impact and relevant abstracts and manuscripts. This call for proposals presumes the following approach to collaborative research:

  • Oncology researchers from US institutions and practices will bring forth ideas that are reasonably able to be examined using the available data set and will meet the additional criteria described below.
  • Foundation Medicine will defer to the clinical and research expertise of the awardee to direct the approved research. No patient-level data will be transferred. Instead, awardees will work with Foundation Medicine’s Real-World Outcomes Research (RWOR) Team on statistical analysis plans and co-creation of abstracts or manuscripts, consistent with International Committee of Medical Journal Editors best practices. Together with collaborators, Foundation Medicine’s RWOR Team has published insights related to predictive biomarkers to aid clinical decisions3-13, when, where, and how to optimally perform NGS testing in clinical practice9,14-16, tumor evolution5,9,10, and treatment inequities17.
  • No financial support will be provided to investigators for awarded projects. 
     

Data

The Flatiron Health-Foundation Medicine Clinico-genomic Database contains de-identified patient data from approximately 280 US cancer clinics (~800 sites of care) derived from electronic health records (EHR), linked to genomic data derived from FMI testing1. The database currently has extensive genomic, demographic, clinical, laboratory, granular treatment timing, and survival data on over 125,000 patients. The representativeness of the database relative to the broader population of patients with cancer in the United States has previously been established by comparison to SEER2.


Examples of variables include: self-reported race; genetic ancestry as determined by a classifier trained to distinguish between the five ancestral superpopulations of the 1000 Genomes Project2,3; socioeconomic status; timing of treatments and prior treatments in relation to timing of Foundation Medicine testing; and, clinical trial information.


Additionally, patients with liquid biopsy results will have records of ctDNA tumor fraction, a prognostic feature4 and proxy for disease burden that is completely algorithmic and independent of potential clinical subjective biases. 
 

Application Mechanism and Notification

Eligibility Criteria and Geographic Scope:

Applicants must be US-based, and actively involved in the care of people with cancer or research related to health equity in cancer care.

Submission Instructions for RFC Proposal:
  1. Applicants who meet the eligibility criteria and are interested in submitting a response to this Request for Collaboration (RFC) are encouraged to submit a feasibility assessment in CGDB prior to full submission by contacting a Medical Science Liaison for a research discussion. 
  2. The deadline for full submission will be June 16, 2025. Please submit your submission HERE.
  3. A member of the Medical Affairs team at Foundation Medicine, Inc. will email a notification of acceptance to applicants.

 

Award Decision Date/Mechanism: 

All received applications will undergo rigorous review by a committee including experts in the field of cancer health equity research, as well as select Foundation Medicine scientists to ensure data fit for purpose in the Flatiron Health-Foundation Medicine Clinico-genomic Database. The below scoring criteria will be used to rank applications: 

CriteriaRating (1-3)
Scientific Rationale & Priors 
Hypothesis 
Feasibility 
Immediacy of Impact 
Breadth of Impact 
Criteria for assessment:
  • Scientific Rationale & Priors: Diligent background of clinical and biological context and rationale for the project (1-2 paragraphs, 5+ scientific references recommended).
  • Hypothesis: Clear, testable, directional hypothesis. Example: we hypothesize that patients with de novo metastatic prostate cancer with SPOP mutations will have exceptionally good outcomes on 2nd generation hormonal therapy without chemotherapy compared to those without SPOP mutations, whereas this effect will not be seen with chemotherapy alone.
  • Feasibility: Fit for purpose of the Flatiron Health-Foundation Medicine Clinico-genomic Database to test the hypothesis, especially in relation to publicly available databases. While not mandatory, potential applicants to this RFC are strongly encouraged to request a feasibility assessment in CGDB prior to submission. Such a request can be submitted through the Medical Science Liaison or scientific representative and has a turnaround time of roughly one week.
  • Immediacy of Impact: Clear path to tangibly and immediately improve the treatment of patients with cancer. Example: If our hypothesis is correct, patients with de novo metastatic prostate cancer and SPOP mutations might be de-risked to attempt a chemotherapy-free treatment regimen.
  • Breadth of Impact: Maximizes number of patients whose care might be improved, and potentially, the degree of benefit anticipated if hypothesis is correct. 
     

There have been no pre-determined approvals. All submissions will be reviewed equally and thoroughly. 
 

Applicants should not respond to this RFC unless they have read and understood the terms, purpose and requests identified below. Applicants are expected to identify and address issues that are aligned to this RFC. 
 

References:

  1. Singal G, Miller PG, Agarwala V, et al: Association of Patient Characteristics and Tumor Genomics With Clinical Outcomes Among Patients With Non-Small Cell Lung Cancer Using a Clinicogenomic Database. JAMA 321:1391-1399, 2019
  2. Mata DA, Rotenstein LS, Ramos MA, et al: Disparities According to Genetic Ancestry in the Use of Precision Oncology Assays. New England Journal of Medicine 388:281-283, 2023
  3. Auton A, Brooks LD, Durbin RM, et al: A global reference for human genetic variation. Nature 526:68-74, 2015
  4. Reichert ZR, Morgan TM, Li G, et al: Prognostic value of plasma circulating tumor DNA fraction across four common cancer types: a real-world outcomes study. Ann Oncol 34:111-120, 2023
  5. Graf RP, Fisher V, Creeden J, et al: Real-world Validation of TMB and Microsatellite Instability as Predictive Biomarkers of Immune Checkpoint Inhibitor Effectiveness in Advanced Gastroesophageal Cancer. Cancer Research Communications, 2022
  6. Graf RP, Fisher V, Huang RSP, et al: Tumor Mutational Burden as a Predictor of First-Line Immune Checkpoint Inhibitor Versus Carboplatin Benefit in Cisplatin-Unfit Patients With Urothelial Carcinoma. JCO Precis Oncol 6:e2200121, 2022
  7. Graf RP, Fisher V, Mateo J, et al: Predictive Genomic Biomarkers of Hormonal Therapy Versus Chemotherapy Benefit in Metastatic Castration-resistant Prostate Cancer. European Urology, 2021
  8. Graf RP, Fisher V, Weberpals J, et al: Comparative Effectiveness of Immune Checkpoint Inhibitors vs Chemotherapy by Tumor Mutational Burden in Metastatic Castration-Resistant Prostate Cancer. JAMA Netw Open 5:e225394, 2022
  9. Hill BL, Graf RP, Shah K, et al: Mismatch repair deficiency, next-generation sequencing-based microsatellite instability, and tumor mutational burden as predictive biomarkers for immune checkpoint inhibitor effectiveness in frontline treatment of advanced stage endometrial cancer. Int J Gynecol Cancer 33:504-513, 2023
  10. Swami U, Graf RP, Nussenzveig RH, et al: SPOP mutations as a Predictive Biomarker for Androgen Receptor-Axis-Targeted Therapy in De Novo Metastatic Castration-Sensitive Prostate Cancer. Clin Cancer Res, 2022
  11. Zurita AJ, Graf RP, Villacampa G, et al: Genomic Biomarkers and Genome-Wide Loss-of-Heterozygosity Scores in Metastatic Prostate Cancer Following Progression on Androgen-Targeting Therapies. JCO Precision Oncology:e2200195, 2022
  12. Emmett MJ, Quintanilha JCF, Graf RP, et al: Toward optimizing patient selection for EGFR antibody therapies in metastatic colorectal cancer: outcomes and resistance features in real-world data. ESMO Real World Data and Digital Oncology 4, 2024
  13. Quintanilha JCF, Graf RP, Fisher VA, et al: Comparative Effectiveness of Immune Checkpoint Inhibitors vs Chemotherapy in Patients With Metastatic Colorectal Cancer With Measures of Microsatellite Instability, Mismatch Repair, or Tumor Mutational Burden. JAMA Network Open 6:e2252244-e2252244, 2023
  14. Quintanilha JCF, Graf RP, Oxnard GR: BRAF V600E and RNF43 Co-mutations Predict Patient Outcomes with Targeted Therapies in Real-World Cases of Colorectal Cancer. The Oncologist 28:e171-e174, 2023
  15. Quintanilha JCF, Storandt MH, Graf RP, et al: Tumor Mutational Burden in Real-World Patients With Pancreatic Cancer: Genomic Alterations and Predictive Value for Immune Checkpoint Inhibitor Effectiveness. JCO Precis Oncol 7:e2300092, 2023
  16. Rolfo CD, Madison RW, Pasquina LW, et al: Measurement of ctDNA Tumor Fraction Identifies Informative Negative Liquid Biopsy Results and Informs Value of Tissue Confirmation. Clin Cancer Res, 2024
  17. Antonarakis ES, Tierno M, Fisher V, et al: Clinical and pathological features associated with circulating tumor DNA content in real-world patients with metastatic prostate cancer. Prostate 82:867-875, 2022
  18. Hiemenz MC, Graf RP, Schiavone K, et al: Real-World Comprehensive Genomic Profiling Success Rates in Tissue and Liquid Prostate Carcinoma Specimens. Oncologist 27:e970-e972, 2022
  19. Sivakumar S, Lee JK, Moore JA, et al: Comprehensive genomic profiling and treatment patterns across ancestries in advanced prostate cancer: a large-scale retrospective analysis. Lancet Digit Health 5:e380-e389, 2023