- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060770
Transcriptomic Study of IBD-associated Colorectal Cancer
September 29, 2021 updated by: MULLER Marie, Central Hospital, Nancy, France
Transcriptiomic Analysis of Inflammatory Bowel Disease-associated Colorectal Cancer. A French Retrospective Study of 26 Cases Identified at the Nancy University Hospital
Chronic inflammatory bowel disease (IBD) is associated with an increased risk of colorectal cancer (CRC) in historical cohorts.
The pathways of oncogenesis of these CRCs, which are very different clinically from de novo CRCs, are currently unknown.
The aim of our work is to identify specific molecular signatures of CRC occurring in the setting of IBD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
26
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
>/= 18 years old patient operated on at the Nancy university hospital for IBD associated CRC
Description
Inclusion Criteria:
- Person 18 years of age or older
- Person with colorectal cancer in the context of IBD
- Person who has received complete information on the organization of the research and who has signed an informed consent
- Person affiliated to a social security plan or beneficiary of such a plan.
Exclusion Criteria:
- Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code:
- Pregnant woman, parturient or nursing mother
- Minor (not emancipated)
- Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- Person of legal age who is unable to express his or her consent
- Person deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IBD associated CRC oncogenesis
Time Frame: 1 year
|
Percentage of gene expression variation in CRC tumor tissue samples in the following groups patients with CRC and IBD
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2010
Primary Completion (ACTUAL)
January 1, 2021
Study Completion (ACTUAL)
January 1, 2021
Study Registration Dates
First Submitted
September 19, 2021
First Submitted That Met QC Criteria
September 19, 2021
First Posted (ACTUAL)
September 29, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 7, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021PI125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.