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NCT Number: NCT07605702

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

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Key information

Conditions

Gastrointestinal Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases GI Cancer GI Cancers Gastrointestinal Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site PDAC PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC San Diego Health, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Retrospective Cohort:

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

Prospective Cohort:

  • Prisoners will not be approached for participation.

Treatment and study plan

Primary outcomes

  1. Number of participants enrolled in registry

    Time frame: Up to 120 months

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

Secondary outcomes

  1. Objective Response Rate (ORR)

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

    For each line of therapy, best overall response where RECIST 1.1 is available.

  2. Progression-Free Survival (PFS)

    Time frame: 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).

  3. Time to Selection of Next Therapy

    Time frame: 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.

  4. Molecular Testing Rate

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

    Percent of participants undergoing germline and somatic tumor testing.

  5. Clinical Trial Offer / Enrollment Rate

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

    Percent offered and percent enrolled in a clinical trial at any site.

  6. Targeted Therapy Utilization

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

    Proportion receiving targeted therapy

  7. Overall Survival (OS)

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

    OS from diagnosis and from development of advanced disease.

  8. Patient-Reported Outcomes (PROMs/PREMs)

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

    To collect patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs).

Study contacts

Contact information is provided by the study sponsor or research team.

Canopy Support

CONTACT

[email protected]

408-907-0137

Sponsors and collaborators

Lead sponsor

Canopy Cancer Collective, LLC

Network

Registry information

Important dates

Study start
2026
Primary completion
2036
Study completion
2038
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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