The Canopy Cancer Collective Clinical Registry Protocol

NCT07605702 | Not Yet Recruiting

• 1 other identifier: CCC001
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 10

Brief Summary

The Canopy Cancer Collective Clinical Registry Protocol Non-Interventional Data and Sample Collection Registry Protocol Number of study sites 15 Study Design - Observational, registry Primary Objective To systematically collect and store comprehensive data on gastrointestinal cancer patients, encompassing both their past medical history and future clinical experiences, to address specific future research questions related to these malignancies, to establish and share best practices, and to support quality improvement initiatives focused on enhancing patient care and outcomes. Secondary Objective(s) 1. Leverage the collective to increase access to molecular profile and biomarker (ctDNA) matched clinical trials across the treatment trajectory. 2\. Use real world data and patient reported outcomes to improve patient care throughout the treatment trajectory. Research Procedure(s) Collection of clinical and outcome data and cataloging and facilitating access to physical biological specimens and their associated data for future research purposes. Drugs/Devices used on Study None Study Population Patients with diagnosis of gastrointestinal (GI) cancers who seek care at one of the canopy centers and/or their affiliates Sample Size Up to 30000 patients in the prospective component Up to 70000 subjects will be enrolled on the retrospective component Study Duration for Individual Participants Anticipated to be at least 1 year Study Specific Abbreviations AE: Adverse Event CEC: Clinical Events Committee CT: Computed Tomography iCCA: Intrahepatic cholangiocarcinoma MRI: Magnetic Resonance Imaging OS: Overall Survival PFS: Progression Free Survival

Conditions

GI Cancers; PDAC; Pancreatic Cancer; Colorectal Cancer; PDAC - Pancreatic Ductal Adenocarcinoma; GI Cancer; Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of participants enrolled in registry

  Count of participants enrolled in the Canopy Cancer Collective GI cancer registry (prospective + retrospective).

  Up to 120 months

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  From start of therapy, up to 2 years on average.

• Progression-Free Survival (PFS)

  From start of therapy to disease progression or death, up to 2 years on average.

• Time to Selection of Next Therapy

  From start of therapy to start of subsequent therapy, up to 2 years on average

• Molecular Testing Rate

  Through patient follow-up, up to 2 years on average.

• Clinical Trial Offer / Enrollment Rate

  Through patient follow-up, up to 2 years on average.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a multicenter, retrospective and prospective study designed to build a database and a virtual biospecimen repository of patients with GI cancers.

You may qualify if:

• Retrospective Cohort:
• Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama/Nebraska 19; Puerto Rico 21).
• Must have histologically proven GI cancer seen at the site within the 20 years preceding activation, and are:
• Deceased, or
• Lost to follow-up ( \>1 year lapse in contact since last visit).
• Prospective Cohort:
• Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama/Nebraska 19; Puerto Rico 21).
• Must have histologically proven Gastrointestinal (GI) cancer.
• Patient or legally authorized representative capable of understanding and willing to provide signed informed consent (assent if applicable).
• Patient/Legally Authorized Representative (LAR) agrees to collection of clinical data and information available on archival tissue and subsequent excess specimens obtained as part of standard-of-care.

You may not qualify if:

• Retrospective Cohort:
• \. Cases in which patient's medical chart denotes restricted use of health information.
• Prospective Cohort:
• \. Prisoners will not be approached for participation.

Sponsors & Collaborators

• Canopy Cancer Collective, LLC: lead

Study Sites (10)

UC San Diego Health

San Diego, California, 92093, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Mt. Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Fred Hutch

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Michael Pishvaian, MD, PhD

  Johns Hopkins University

  STUDY CHAIR

Central Study Contacts

Canopy Support

CONTACT

408-907-0137; CanopySupport@canopycancer.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2036
• Study Completion (Estimated): May 1, 2038
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Access Criteria: IRB approval as applicable; CCC Research Governance Committee / Research Committee review; execution of a data use agreement (DUA) defining permitted uses, prohibitions on re-identification, security controls, and sharing/open access expectations.

Locations

US (10)