Colon AdenomaSPARC-CNCT05402696
St. Paul's Advanced Resection Center Cohort for Colorectal Neoplasia (SPARC-C)
An observational study of Colon Adenoma and Colon Polyp, run by University of British Columbia at 6 sites in 3 countries.
Trial summary
The SPARC-C study is a prospective, multi-institutional observational study of patients referred for the management of large (≥ 20mm) non-pedunculated colorectal polyps (LNPCPs). Patients are managed consistent with current standards of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Adenoma, Colon Polyp, Colon Lesion
- What is being tested?
- Endoscopic tissue resection
- Type of treatment
- Surgery or procedure
- How many people
- 3,500 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 27 Jun 2022to 31 Dec 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
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: Patients ≥18 years of age who have been referred to St. Paul's Hospital from 2022 to 2032 for management of a large (≥20mm) non-pedunculated colorectal polyp (LNPCP).
Who may be able to join
- Patients ≥ 18 years of age referred for the management of an LNPCP
- Able to provide informed consent.
Who cannot join
- Unable to provide informed consent
- Pregnant or lactating women.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Canada4 sites, 3 recruiting
- Active, not recruiting
Mount Saint Joseph Hospital
Vancouver, British Columbia, V5T 3N4
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V6B2W6
Shirley X Jiang, MD, (604) 688-6332, sjiangx@alumni.ubc.ca
Cherry Galorport, (604) 688-6332, CGalorport@providencehealth.bc.ca
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Shirley X Jiang, (604) 688-6332, sjiangx@alumni.ubc.ca
Cherry Galorport, (604) 688-6332, CGalorport@providencehealth.bc.ca
- Recruiting
Pacific Gastroenterology Associates
Vancouver, British Columbia, V6Z 2K5
Shirley X Jiang, (604) 688-6332, sjiangx@alumni.ubc.ca
Cherry Galorport, (604) 688-6332, CGalorport@providencehealth.bc.ca
United States1 site, 1 recruiting
- Recruiting
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
Fateh Bazerbachi, MD
About this study
Official title: The St. Paul's Hospital Advanced Endoscopic Resection Centre Cohort for Colorectal Neoplasia (SPARC-C): A Prospective Observational Study
The SPARC-C study is a prospective, multi-institutional observational study of patients referred for the management of large (≥ 20mm) non-pedunculated colorectal polyps (LNPCPs). Patients are managed consistent with current standards of care. Prospectively collected data includes: patient clinicodemographic details, lesion details, procedural details, and clinical outcomes.
Read the detailed description
Endoscopic resection techniques, including endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and cold snare resection (CSR), have become the primary treatment strategy for the vast majority of large non-pedunculated colorectal polyps (LNPCPs). This is because of the efficacy, safety, and cost-effectiveness of endoscopic techniques compared to surgery. Site-specific technical modifications and the development of auxiliary techniques/strategies have mitigated the risk of technical failure, clinically significant post-resection bleeding (CSPEB), significant deep mural injury (S-DMI)/perforation, and recurrence. However, questions still remain about the application and selection of these techniques.
This is a prospective, multicentre cohort study of consecutive patients referred to an interventional endoscopist with a tertiary referral practice in minimally invasive endoscopic resection techniques for the management of a LNPCP. This study will be based at St. Paul's Hospital (and its affiliated sites), Vancouver General Hospital, and collaborating sites, with the aim of enrolling 3500 participants over 10 years.
This cohort serves as a platform to continue refining the management of LNPCPs. We will evaluate LNPCP management outcomes, including technical success, clinical success, clinically significant intra-procedural bleeding (CSIPB), S-DMI, CSPEB, delayed perforation, recurrence, and referral to surgery. Findings will also help to further refine mitigating strategies for intra-procedural and post-procedural adverse outcomes (CSPIB, S-DMI, CSPEB, delayed perforation, recurrence, and referral to surgery). Finally, we aim to optimize the application of minimally invasive endoscopic resection techniques for the management of LNPCPs, including the development of artificial intelligence clinical decision support solutions (AI-CDSS).
- Conditions
- Colon Adenoma, Colon Polyp, Colon Lesion
- Being tested
- Endoscopic tissue resection
- Keywords
- Colorectal neoplasia, Advanced endoscopy, Endoscopic resection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic tissue resectionProcedure or surgery
Also called Endoscopic mucosal resection, Endoscopic submucosal dissection, Colonoscopic polypectomy
Endoscopic resection techniques for removal of large polyps
| Study group | Role | What they receive |
|---|---|---|
| Large non-pedunculated colorectal polyp (LNPCP) | Patients referred to St. Paul's Hospital for endoscopic management of a large (≥20mm) non-pedunculated colorectal polyp (LNPCP). Receives: Procedure: Endoscopic tissue resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success of Endoscopic Procedure
Complete removal of all visible polypoid tissue during index procedure.
Measured: Intra-procedure
Clinical Success of Endoscopic Procedure
Technical success and the avoidance of surgery for large non-pedunculated colorectal polyps (LNPCPs) referred for endoscopic resection, assessed at first surveillance colonoscopy. LNPCPs with features consistent with invasive disease and directly referred for surgery are excluded.
Measured: 6 months
Secondary outcomes (1)
Peri-Procedural Adverse Outcomes
Frequency and management of peri-procedural adverse outcomes including clinically significant intra-procedural bleeding, significant deep mural injury, clinically significant post-resection bleeding, delayed perforation, recurrence, and referral to surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start27 Jun 2022
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenomaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 3,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- CentraCare, Hadassah Medical Organization, Vancouver Coastal Health Research Institute, Providence Healthcare
- Responsible party
- Principal investigator, Neal Shahidi, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402696
- Sponsor's protocol ID
- H22-00037
- Acronym
- SPARC-C
- Status last verified
- May 2026
- First submitted
- 28 May 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No