The Canopy Cancer Collective Clinical Registry Protocol

NCT07605702 — Not yet recruiting, 100000 participants, Canopy Cancer Collective, LLC

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Registry	NCT07605702
Status	Not yet recruiting
Study type	Observational
Enrollment	100000 (Estimated)
Sponsor	Canopy Cancer Collective, LLC (Network)
Conditions	Gastrointestinal Neoplasms, Pancreatic Cancer, Colorectal Cancer, GI Cancers, PDAC - Pancreatic Ductal Adenocarcinoma, PDAC, GI Cancer
Dates	start 2026-05-01 (estimated), primary completion 2036-05-01 (estimated), completion 2038-05-01 (estimated), first posted 2026-05-26, last updated 2026-05-26
Locations	10 sites in United States

-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

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+Outcome measures

Primary outcomes

Number of participants enrolled in registry [Up to 120 months]: Count of participants enrolled in the Canopy Cancer Collective GI cancer registry (prospective + retrospective).

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (10)

Facility	City	Country
UC San Diego Health	San Diego, California	United States
Moffitt Cancer Center	Tampa, Florida	United States
Sidney Kimmel Comprehensive Cancer Center	Baltimore, Maryland	United States
Roswell Park Comprehensive Cancer Center	Buffalo, New York	United States
Northwell Health	Lake Success, New York	United States
Mt. Sinai	New York, New York	United States
Cleveland Clinic	Cleveland, Ohio	United States
UT Southwestern Medical Center	Dallas, Texas	United States
UT Health San Antonio	San Antonio, Texas	United States
Fred Hutch	Seattle, Washington	United States

+Investigators

Michael Pishvaian, MD, PhD, Study chair, Johns Hopkins University