The Canopy Cancer Collective Clinical Registry Protocol

ClinicalTrials.gov ID

NCT07605702

Lead Sponsor

Canopy Cancer Collective, LLCNETWORK

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

100,000Estimated

Last Update Posted

May 26, 2026Actual

Start Date

May 2026Estimated

Primary Completion Date

May 2036Estimated

Completion Date

May 2038Estimated

Official Title

The Canopy Cancer Collective Clinical Registry Protocol

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

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Other

Lead Sponsor

Canopy Cancer Collective, LLCNETWORK

sarah.hoffe@moffitt.org888-663-3488

anarang2@jhmi.edu410-502-8000

Christos.fountzilas@roswellpark.org716-845-2300

dking14@northwell.edu516-734-8900

Karyn.Goodman@mountsinai.org212-241-0385

wehrlec@ccf.org216-399-9665

todd.aguilera@utsouthwestern.edu214-645-5383

tulir@uthscsa.edu210-567-7000

acoveler@uw.edu206-606-7509

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