The Canopy Cancer Collective Clinical Registry Protocol

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

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Neoplasms; Colorectal Cancer; Pancreatic Cancer; GI Cancer; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; GI Cancers

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

• Study Contact: Name: Canopy Support; Phone Number: 408-907-0137; Email: CanopySupport@canopycancer.org

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • UC San Diego Health
      • Contact: Gregory Botta, MD; Phone Number: 866-773-2703; Email: gbotta@health.ucsd.edu
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
      • Contact: Sarah Hoffe, MD; Phone Number: 888-663-3488; Email: sarah.hoffe@moffitt.org
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Sidney Kimmel Comprehensive Cancer Center
      • Contact: Amol Narang, MD; Phone Number: 410-502-8000; Email: anarang2@jhmi.edu
  • New York
    • Buffalo, New York, United States, 14203
      • Roswell Park Comprehensive Cancer Center
      • Contact: Christos Fountzilas, MD; Phone Number: 716-845-2300; Email: Christos.fountzilas@roswellpark.org
    • Lake Success, New York, United States, 11042
      • Northwell Health
      • Contact: Dan King, MD; Phone Number: 516-734-8900; Email: dking14@northwell.edu
    • New York, New York, United States, 10029
      • Mt. Sinai
      • Contact: Karyn Goodman; Phone Number: 212-241-0385; Email: Karyn.Goodman@mountsinai.org
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
      • Contact: Chase Wehrle, MD; Phone Number: 216-399-9665; Email: wehrlec@ccf.org
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
      • Contact: Todd Aguilera, MD; Phone Number: 214-645-5383; Email: todd.aguilera@utsouthwestern.edu
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio
      • Contact: Rich Tuli, MD; Phone Number: 210-567-7000; Email: tulir@uthscsa.edu
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch
      • Contact: Andrew Coveler, MD; Phone Number: 206-606-7509; Email: acoveler@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

Retrospective Cohort:

1. Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama/Nebraska 19; Puerto Rico 21).

2. Must have histologically proven GI cancer seen at the site within the 20 years preceding activation, and are:

   1. Deceased, or
   2. Lost to follow-up ( >1 year lapse in contact since last visit).

Prospective Cohort:

1. Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama/Nebraska 19; Puerto Rico 21).
2. Must have histologically proven Gastrointestinal (GI) cancer.
3. Patient or legally authorized representative capable of understanding and willing to provide signed informed consent (assent if applicable).
4. 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.

Exclusion Criteria:

Retrospective Cohort:

1. Cases in which patient's medical chart denotes restricted use of health information.

Prospective Cohort:

1. Prisoners will not be approached for participation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	For each line of therapy, best overall response where RECIST 1.1 is available.	From start of therapy, up to 2 years on average.
Progression-Free Survival (PFS)	Time from start of each line of therapy to disease progression or death (as available).	From start of therapy to disease progression or death, up to 2 years on average.
Time to Selection of Next Therapy	Time from start of a line of therapy to initiation of subsequent therapy.	From start of therapy to start of subsequent therapy, up to 2 years on average
Molecular Testing Rate	Percent of participants undergoing germline and somatic tumor testing.	Through patient follow-up, up to 2 years on average.
Clinical Trial Offer / Enrollment Rate	Percent offered and percent enrolled in a clinical trial at any site.	Through patient follow-up, up to 2 years on average.
Targeted Therapy Utilization	Proportion receiving targeted therapy	Through patient follow-up, up to 2 years on average.
Overall Survival (OS)	OS from diagnosis and from development of advanced disease.	Through patient follow-up, up to 2 years on average.
Patient-Reported Outcomes (PROMs/PREMs)	To collect patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs).	Through patient follow-up, up to 2 years on average.

Collaborators and Investigators

• Sponsor: Canopy Cancer Collective, LLC
• Investigators: Study Chair: Michael Pishvaian, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2036
• Study Completion (Estimated): May 1, 2038

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Colonic Diseases; Colorectal Neoplasms; Pancreatic Neoplasms; Gastrointestinal Neoplasms
• Other Study ID Numbers: CCC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant-level registry data and de-identified biospecimen data; consistent with consent, IRB approvals, and governance review.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No