The Canopy Cancer Collective Clinical Registry Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Neoplasms, Pancreatic Cancer, Colorectal Cancer, GI Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Primary outcome measures
- Number of participants enrolled in registry [Time frame: Up to 120 months]
Secondary outcome measures (8)
- Objective Response Rate (ORR) [Time frame: From start of therapy, up to 2 years on average.]
- Progression-Free Survival (PFS) [Time frame: From start of therapy to disease progression or death, up to 2 years on average.]
- Time to Selection of Next Therapy [Time frame: From start of therapy to start of subsequent therapy, up to 2 years on average]
- Molecular Testing Rate [Time frame: Through patient follow-up, up to 2 years on average.]
- Clinical Trial Offer / Enrollment Rate [Time frame: Through patient follow-up, up to 2 years on average.]
- Targeted Therapy Utilization [Time frame: Through patient follow-up, up to 2 years on average.]
- Overall Survival (OS) [Time frame: Through patient follow-up, up to 2 years on average.]
- Patient-Reported Outcomes (PROMs/PREMs) [Time frame: Through patient follow-up, up to 2 years on average.]
Eligibility criteria
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:
1\. Cases in which patient's medical chart denotes restricted use of health information.
Prospective Cohort:
1\. Prisoners will not be approached for participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 10 centers
- UC San Diego Health — San Diego
- Moffitt Cancer Center — Tampa
- Sidney Kimmel Comprehensive Cancer Center — Baltimore
- Roswell Park Comprehensive Cancer Center — Buffalo
- Northwell Health — Lake Success
- Mt. Sinai — New York
- Cleveland Clinic — Cleveland
- UT Southwestern Medical Center — Dallas
- … and 2 more centers
Identifiers
NCT: NCT07605702 · CCC001