Colorectal Cancer in Crohn's Disease
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|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
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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 Type :||Observational|
|Estimated Enrollment :||70 participants|
|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|
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
- Overall Survival [ Time Frame: 5 years ]percentage of patients alive
- disease free survival [ Time Frame: 5 years ]percentage of patients disease free
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|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|
- 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
- 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)
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
|Contact: Bruno Sensi, MDemail@example.com|
|Contact: Giuseppe S Sica, MD, PhDfirstname.lastname@example.org|
|Policlinico Tor Vergata||Recruiting|
|Roma, RM, Italy, 00133|
|Contact: Bruno Sensi, MD 3385352902 email@example.com|
|Contact: Giuseppe S Sica, MD, PhD 3385333659 firstname.lastname@example.org|
|Responsible Party:||Giuseppe Sigismondo Sica, Associate Professor, Head of Department, University of Rome Tor Vergata|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Inflammatory Bowel Diseases
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases