Building a patient-driven, integrated research infrastructure to accelerate therapeutic advances in colorectal cancer.

K Kimberley Lynn Newcomer (Colorectal Cancer Alliance, Washington, DC) T Travis Hyams (Colorectal Cancer Alliance, Washington, DC) T Tina Zeff (Colorectal Cancer Alliance, Washington, DC) M Marc Mason (Colon Cancer Alliance, Washington, DC) D David A. Fenstermacher (Colorectal Cancer Alliance, Washington, DC) E Erin Siegel (10NIH, Bethesda, United States) M Michael Sapienza (Colorectal Cancer Alliance, Washington, DC)

Abstract

e15615 Background: Despite major scientific advances, colorectal cancer (CRC) remains a leading cause of cancer-related mortality. Progress toward improved outcomes has been constrained by siloed datasets, limited inclusion of diverse patient populations, and slow translation of discovery science into clinical impact. To address these challenges, the Colorectal Cancer Alliance initiated Project Cure CRC in 2023 as a national, patient-centered research infrastructure designed to integrate data, clinical investigation, and collaborative discovery. The initiative seeks to shorten the path from biological insight to effective therapies while improving survival and equity in CRC care. Methods: Project Cure CRC integrates four complementary pillars into a unified ecosystem. First, an adaptive clinical trial framework evaluating perioperative, neoadjuvant, and minimal residual disease (MRD) strategies across CRC subtypes. Second, BlueLake serves as a real-world evidence and data integration platform, linking clinical, molecular, and patient-reported outcomes to support hypothesis generation and care optimization. Third, BlueHQ provides a digital engagement environment that enables patient navigation, peer connection, longitudinal data contribution, education, and participation in research. Fourth, a competitive and peer-reviewed funding program supports early-career investigators, senior investigators, pilot studies, and team science initiatives, with an explicit mandate to feed discoveries into the adaptive clinical trial and BlueLake for rapid validation and translation. Results: Since inception, Project Cure CRC has reviewed more than 525 research proposals and allocated over $15 million in funding to 33 projects spanning biomarker development, translational science, and health equity. The program has engaged more than 150 academic investigators, 20 industry collaborators, and a growing cohort of patient participants, establishing the largest philanthropic CRC research network in the United States. Governance structures supporting FDA submission of the adaptive trial platform have been completed, and in 2025 a diverse patient advisory council was launched to guide ecosystem development and ensure patient-centered priorities. Conclusions: Project Cure CRC represents a scalable model for aligning patients, data, and discovery within an integrated research infrastructure. By combining adaptive clinical trials, real-world data, sustained patient engagement, and targeted research investment, the initiative is accelerating translational progress and redefining how colorectal cancer research is conducted. This ecosystem approach offers a blueprint for advancing cures across complex disease landscapes.

Article Details

Volume / Issue Vol. 44, Issue 16_suppl
Published June 01, 2026
ISSN 0732-183X
Publisher Lippincott Williams & Wilkins

Journal Info

Journal of Clinical Oncology

Lippincott Williams & Wilkins

ISSN: 0732-183X Health Sciences

Authors (7)

K

Kimberley Lynn Newcomer

Colorectal Cancer Alliance, Washington, DC

T

Travis Hyams

Colorectal Cancer Alliance, Washington, DC

T

Tina Zeff

Colorectal Cancer Alliance, Washington, DC

M

Marc Mason

Colon Cancer Alliance, Washington, DC

D

David A. Fenstermacher

Colorectal Cancer Alliance, Washington, DC

E

Erin Siegel

10NIH, Bethesda, United States

M

Michael Sapienza

Colorectal Cancer Alliance, Washington, DC