Colorectal Cancer in Crohn's Disease

• ClinicalTrials.gov Identifier: NCT04654494
• Recruitment Status: Unknown
• First Posted: December 4, 2020
• Last Update Posted: December 8, 2020
• Sponsor: University of Rome Tor Vergata
• Information provided by (Responsible Party): Giuseppe Sigismondo Sica, University of Rome Tor Vergata

Tracking Information

• First Submitted Date: November 29, 2020
• First Posted Date: December 4, 2020
• Last Update Posted Date: December 8, 2020
• Actual Study Start Date: July 1, 2020
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 29, 2020)

• Overall Survival [ Time Frame: 5 years ]
  percentage of patients alive
• disease free survival [ Time Frame: 5 years ]
  percentage of patients disease free

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Colorectal Cancer in Crohn's Disease
• Official Title: Colorectal Cancer in Crohn's Disease: Long Term Outcomes of Different Surgical Procedures

Brief Summary

Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset.

Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible.

The study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR).

Primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL).

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with Crohn's disease complicated by occurrence of colorectal cancer, treated surgically between 01/2010 and 01/2020

Condition

• Crohn Disease
• Colorectal Cancer
• Inflammatory Bowel Diseases

Intervention

• Procedure: Total proctocolectomy
  excision of the whole large bowel including colon and rectum and end ileostomy fashioning
• Procedure: Total colectomy
  excision of the colon with preservation of the rectum
• Procedure: Segmental colectomy
  excision of a segment of colon

Study Groups/Cohorts

Chron's disease patients with colorectal cancer

This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically

Interventions:

• Procedure: Total proctocolectomy
• Procedure: Total colectomy
• Procedure: Segmental colectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 29, 2020): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2021
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All patients with a diagnosis of Crohn's disease and concomitant primary colorectal cancer who underwent surgery in an expert centre between 01/01/2010 and 01/01/2020

Exclusion Criteria:

• Patients who underwent non-oncologic segmental resection will be excluded from outcome analysis.
• Patients with known genetic colorectal cancer syndromes (eg. Familial Adenomatous Polyposis, Hereditary Non-Polyposis ColoRectal Cancer Syndrome)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04654494
• Other Study ID Numbers: REGISTROSPERIMENTAZIONI120/20
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Giuseppe Sigismondo Sica, University of Rome Tor Vergata
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Rome Tor Vergata
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Rome Tor Vergata
• Verification Date: December 2020