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NCT04103567Recruiting

Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Treatment in Rectal Cancers

Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Therapy in Rectal Cancers: Focus on Cyclomodulin-producing Escherichia Coli

Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The objective of this project is to determine in a non-invasive manner (fecal samples) the predictive value of the intestinal microbiota and the presence of genotoxin-producing bacteria on the response to neoadjuvant treatment in rectal cancer. This could lead to a better understanding and selection of patients for personalized treatment in rectal cancer.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
220 (estimated)
First submitted
24 Sept 2019
Start date
14 Jan 2020
Primary completion date
30 Jan 2026
Lead sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
NCT number
NCT04103567

What you commit to

  • Study type: Interventional
  • Planned participants: 220
  • From 14 Jan 2020 to the primary completion date, 30 Jan 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment for rectal cancer
  • Prior radiation therapy or pelvic curia in the year prior to inclusion

Other illness

  • History of other cancers in the last 5 years (except for in-situ cervical carcinomas and non-melanoma skin carcinomas treated optimally)

Other

  • Antibiotic treatment at the time or in the month preceding stool sampling
  • Presence of an ostomy
  • Patient not affiliated to a French social protection system
  • Patient not in favour of good compliance with treatment for psychological, family, social or geographical reasons
  • Legal incapacity (Patient under curatorship or guardianship)
  • Pregnant or breastfeeding woman

Who the study is looking for

  • Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III
  • Patient is to receive neoadjuvant treatment (radiochemotherapy or chemotherapy or radiotherapy). Induction chemotherapy such as folfox or folfirinox is allowed
  • Patient who has signed the informed consent of the study
  • Male or female ≥ 18 years old
  • Appropriate contraceptive measures should be used by both men and non-menopausal women before entering the trial until at least 8 weeks after the last course of radiochemotherapy. The investigator should inform the patient about the contraceptive measures to be used.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceNot yet recruiting
Institut Regional Du Cancer de Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.