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Status unknownNCT05172713ColonoScopyUpdated Dec 29, 2021

Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test

An observational study in Colorectal Cancer, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-12-29.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
50 Years to 75 Years
Sex
All
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Study summary

In France, colorectal cancer (CRC) is the second leading cause of cancer death. Its organized screening (Organized ColoRectal Cancer Screening: DOCCR), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. When the immunological test is positive, the Haute Autorité de Santé recommends a total colonoscopy. In 5 to 10% of cases, this colonoscopy is incomplete. The renewal of the endoscopic procedure or the performance of additional second-line examinations are then recommended. At present, however, the respective place of second-line examinations to be performed in this situation is not the subject of specific and validated recommendations.

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Conditions studied

  • Colorectal Cancer

Keywords

  • Colorectal cancer
  • Immunological test
  • Colonoscopy
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 100 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 968 studies on the registry; 344 are open to participants now.

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

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Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subject aged between 50 and 75 years old at the time of the colonoscopy with incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR

Inclusion criteria

  • Age between 50 and 75 years old at the time of the colonoscopy
  • With incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR
  • Patient whose follow-up has ended
  • Patient living in the Grand-Est region and in the department of the site concerned
  • Examination carried out by a gastroenterologist from the Grand-Est region
  • Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria

Exclusion criteria:

  • Age ≥ 76 years at the time of colonoscopy
  • Colonoscopy performed after a positive Hemoccult® test (screening technique older than the immunological test and different sensitivity / specificity)
  • Colonoscopy performed before the fecal immunological test
  • Gastroenterologist performing the examination practicing outside the Grand-Est region
  • Subject not able to understand the objectives of this research
  • Subject under judicial control
  • Subject under tutorship or curatorship
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Retrospective study of the patient outcomes who had an incomplete colonoscopy after a positive immunological fecal test

    Time frame: Files analysed retrospectively from January 01, 2018 to December 31, 2018 will be examined]

07

Study locations

1 of 1 sites recruiting
  • Service Hépato-Gastroentérologie et Assistance Nutritive - Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
    • Jean-Marie REIMUND, MD, PhD · Contact · jean-marie.reimund@chru-strasbourg.fr · 33 3 88 12 74 41
    • Saïd CHAYER, PhD, HDR · Contact · said.chayer@chru-strasbourg.fr
    • Jean-Marie REIMUND, MD, PhD · Principal investigator
    • Isabelle GENDRE, MD · Sub investigator
    • Victor NARDON, MD · Sub investigator
    • Bénédicte CARON, MD · Sub investigator
    • Myriam GUERBAZ, MD · Sub investigator
    • Maurice TANGUY, MD · Sub investigator
    • Joël LACROUTE, MD · Sub investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05172713
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Dec 29, 2021
Start date
Jan 16, 2021
Primary completion
Apr 2022 (estimated)
Completion
Apr 16, 2022 (estimated)
Last update
Dec 29, 2021

Study contacts

Jean-Marie REIMUND, MD, PhD
Contact
jean-marie.reimund@chru-strasbourg.fr
33 3 88 12 74 41
Saïd CHAYER, PhD, HDR
Contact
said.chayer@chru-strasbourg.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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