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

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.

This is a multicenter, retrospective and prospective study designed to build a database and a virtual biospecimen repository of patients with GI cancers.

De-identified participant-level registry data and de-identified biospecimen data; consistent with consent, IRB approvals, and governance review.

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.