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Active, not recruitingNCT01816438Updated Sep 21, 2023

A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia

An observational study in Hyperplasia and Dysplasia, sponsored by Hôpital Edouard Herriot. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Hôpital Edouard Herriot · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions.

It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion.

Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments).

The main criterion evaluation will be the surgical and endoscopic rates during the time.

The treatments offered such as surgical, endoscopic ones or none of them will be followed.

Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.

Read the detailed description

A replay centralized pathological lesion slides corresponding to the different lesion will be done

02

Conditions studied

  • Hyperplasia
  • Dysplasia

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Keywords

  • abnormal histological colorectal lesions
03

In context

Hyperplasia

891 studies on the registry are indexed under Hyperplasia; 103 are open to participants now.

This study's planned enrollment of 300 is above the median of 157 across 238 observational studies indexed under Hyperplasia.

Browse Hyperplasia studies →

Lead sponsor

Hôpital Edouard Herriot is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

In France more than 40000 persons are concerned with a high risk of cancer because of ulcerative colitis for example

Inclusion criteria

  • intestinal chronic inflammatory disease with at least one lesion such as hyperplasia or no dysplastic scalloped lesion, dysplastic scalloped lesion or low grade dysplasia or high grade dysplasia
  • compliant patient
  • endoscopic follow possible
  • no settler cancer
  • no serious pathology such as cancer

Exclusion criteria

Exclusion Criteria:

  • settler cancer
  • serious pathology such as cancer
  • no compliant patient
  • endoscopic follow not possible
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • dysplasia or colorectal lesion

    300 patients

06

What researchers measure

Primary outcomes

  1. endoscopies results

    rates of surgery and endoscopic treatments frequency of development of a cancer or a high grade dysplasia according to a type of abnormal histological colorectal lesion

    Time frame: 4 years

07

Study locations

1 site
  • Edouard Herriot Hospital
    Lyon, Rhône Alpes 69473, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01816438
Lead sponsor
Hôpital Edouard Herriot
Responsible party
Jean Christophe Saurin (Professor, Hôpital Edouard Herriot) — Principal investigator
First posted
Mar 22, 2013
Start date
Jul 2013
Primary completion
Jul 2023
Completion
Jul 2024 (estimated)
Last update
Sep 21, 2023

Study contacts

Saurin Jean Christophe, MSD
principal investigator · no affiliated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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