Gastrointestinal NeoplasmsNCT07605702
The Canopy Cancer Collective Clinical Registry Protocol
An observational study of Gastrointestinal Neoplasms and Pancreatic Cancer, run by Canopy Cancer Collective, LLC at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms, Pancreatic Cancer, Colorectal Cancer
- How many people
- 100,000 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2026to May 2038
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a multicenter, retrospective and prospective study designed to build a database and a virtual biospecimen repository of patients with GI cancers.
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Amol Narang, MD, 410-502-8000, anarang2@jhmi.edu
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Christos Fountzilas, MD, 716-845-2300, Christos.fountzilas@roswellpark.org
Cleveland Clinic
Cleveland, Ohio, 44195
Chase Wehrle, MD, 216-399-9665, wehrlec@ccf.org
UT Southwestern Medical Center
Dallas, Texas, 75390
Todd Aguilera, MD, 214-645-5383, todd.aguilera@utsouthwestern.edu
Northwell Health
Lake Success, New York, 11042
Dan King, MD, 516-734-8900, dking14@northwell.edu
Mt. Sinai
New York, New York, 10029
Karyn Goodman, 212-241-0385, Karyn.Goodman@mountsinai.org
UT Health San Antonio
San Antonio, Texas, 78229
Rich Tuli, MD, 210-567-7000, tulir@uthscsa.edu
UC San Diego Health
San Diego, California, 92093
Gregory Botta, MD, 866-773-2703, gbotta@health.ucsd.edu
Fred Hutch
Seattle, Washington, 98109
Andrew Coveler, MD, 206-606-7509, acoveler@uw.edu
Moffitt Cancer Center
Tampa, Florida, 33612
Sarah Hoffe, MD, 888-663-3488, sarah.hoffe@moffitt.org
About this study
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.
Read more
Secondary Objective(s) 1. Leverage the collective to increase access to molecular profile and biomarker (ctDNA) matched clinical trials across the treatment trajectory.
- 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
- Conditions
- Gastrointestinal Neoplasms, Pancreatic Cancer, Colorectal Cancer, GI Cancers, PDAC - Pancreatic Ductal Adenocarcinoma, PDAC
- Medical subject headings
- Gastrointestinal Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled in registry
Count of participants enrolled in the Canopy Cancer Collective GI cancer registry (prospective + retrospective).
Measured: Up to 120 months
Secondary outcomes (8)
Objective Response Rate (ORR)
For each line of therapy, best overall response where RECIST 1.1 is available.
Measured: From start of therapy, up to 2 years on average.
Progression-Free Survival (PFS)
Time from start of each line of therapy to disease progression or death (as available).
Measured: From start of therapy to disease progression or death, up to 2 years on average.
Time to Selection of Next Therapy
Time from start of a line of therapy to initiation of subsequent therapy.
Measured: From start of therapy to start of subsequent therapy, up to 2 years on average
Molecular Testing Rate
Percent of participants undergoing germline and somatic tumor testing.
Measured: Through patient follow-up, up to 2 years on average.
Clinical Trial Offer / Enrollment Rate
Percent offered and percent enrolled in a clinical trial at any site.
Measured: Through patient follow-up, up to 2 years on average.
Targeted Therapy Utilization
Proportion receiving targeted therapy
Measured: Through patient follow-up, up to 2 years on average.
Overall Survival (OS)
OS from diagnosis and from development of advanced disease.
Measured: Through patient follow-up, up to 2 years on average.
Patient-Reported Outcomes (PROMs/PREMs)
To collect patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs).
Measured: Through patient follow-up, up to 2 years on average.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2036 (estimated)
- Study completionMay 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Canopy Cancer Collective, LLC
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Michael Pishvaian, MD, PhD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605702
- Sponsor's protocol ID
- CCC001
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level registry data and de-identified biospecimen data; consistent with consent, IRB approvals, and governance review.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Canopy Cancer Collective Clinical Registry Protocol
- ClinicalTrials.gov ID
- NCT07605702
- Acronym / sponsor ID
- CCC001
- Conditions
- Gastrointestinal Neoplasms, Pancreatic Cancer, Colorectal Cancer, GI Cancers, PDAC - Pancreatic Ductal Adenocarcinoma, PDAC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Canopy Cancer Collective, LLCResearch network
- Study start
- May 2026 (estimated)
- Primary completion
- May 2036 (estimated)
- Study completion
- May 2038 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multicenter, retrospective and prospective study designed to build a database and a virtual biospecimen repository of patients with GI cancers.
Key inclusion criteria (10 listed)
- 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:
- 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).
Key exclusion criteria (4 listed)
- 1. Cases in which patient's medical chart denotes restricted use of health information.
- 1. Prisoners will not be approached for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level registry data and de-identified biospecimen data; consistent with consent, IRB approvals, and governance review.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Pishvaian, MD, PhD study chair
Johns Hopkins University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Neoplasms and Pancreatic Cancer, run by Canopy Cancer Collective, LLC at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Canopy Support (408-907-0137, CanopySupport@canopycancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants enrolled in registry (time frame: Up to 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.