NCT05060770

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
Last Updated

October 7, 2021

Status Verified

September 1, 2021

Enrollment Period

11 years

First QC Date

September 19, 2021

Last Update Submit

September 29, 2021

Conditions

Keywords

inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

  • IBD associated CRC oncogenesis

    Percentage of gene expression variation in CRC tumor tissue samples in the following groups patients with CRC and IBD

    1 year

Interventions

transcriptomic analysis on preserved tumor tissue

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\>/= 18 years old patient operated on at the Nancy university hospital for IBD associated CRC

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGastroenteritis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor (MD, PhD Student), Principal investigator

Study Record Dates

First Submitted

September 19, 2021

First Posted

September 29, 2021

Study Start

January 1, 2010

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

October 7, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share