We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Colorectal Cancer in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04654494
Recruitment Status : Unknown
Verified December 2020 by Giuseppe Sigismondo Sica, University of Rome Tor Vergata.
Recruitment status was:  Recruiting
First Posted : December 4, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Giuseppe Sigismondo Sica, University of Rome Tor Vergata

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment
Crohn Disease Colorectal Cancer Inflammatory Bowel Diseases Procedure: Total proctocolectomy Procedure: Total colectomy Procedure: Segmental colectomy

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Colorectal Cancer in Crohn's Disease: Long Term Outcomes of Different Surgical Procedures
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Chron's disease patients with colorectal cancer
This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    percentage of patients alive

  2. disease free survival [ Time Frame: 5 years ]
    percentage of patients disease free


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654494


Contacts
Layout table for location contacts
Contact: Bruno Sensi, MD 3385352902 brunosensi@outlook.it
Contact: Giuseppe S Sica, MD, PhD 3385333659 sigisica@gmail.com

Locations
Layout table for location information
Italy
Policlinico Tor Vergata Recruiting
Roma, RM, Italy, 00133
Contact: Bruno Sensi, MD    3385352902    brunosensi@outlook.it   
Contact: Giuseppe S Sica, MD, PhD    3385333659    sigisica@gmail.com   
Sponsors and Collaborators
University of Rome Tor Vergata
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Giuseppe Sigismondo Sica, Associate Professor, Head of Department, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT04654494    
Other Study ID Numbers: REGISTROSPERIMENTAZIONI120/20
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe Sigismondo Sica, University of Rome Tor Vergata:
colorectal surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Gastroenteritis