Colorectal Cancer, Gastrointestinal Neoplasms, GI Cancer, GI Cancers, Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
Conditions
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
Interventions
None listed
Sponsors
Canopy Cancer Collective, LLC
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTCanopy Support
STUDY_CHAIRMichael Pishvaian, MD, PhD
Johns Hopkins University
Outcome results
None listed