Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04103567

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

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-02-12

220

Participants Needed

2

Research Sites

524 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven lower and mid-rectal adenocarcinoma at clinical stage II and III
  • Planned neoadjuvant treatment including radiochemotherapy, chemotherapy, or radiotherapy; induction chemotherapy such as folfox or folfirinox allowed
  • Signed informed consent for the study
  • Male or female aged 18 years or older
  • Use of appropriate contraceptive measures by men and non-menopausal women before and at least 8 weeks after last radiochemotherapy course
Not Eligible

You will not qualify if you...

  • Antibiotic treatment at the time of or within one month before stool sampling
  • Presence of an ostomy
  • Previous treatment for rectal cancer
  • Not affiliated with a French social protection system
  • Poor treatment compliance due to psychological, family, social, or geographical reasons
  • Legal incapacity such as under curatorship or guardianship
  • Prior radiation therapy or pelvic curia within one year before inclusion
  • History of other cancers in the last 5 years except treated in-situ cervical carcinomas or non-melanoma skin carcinomas
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Institut régional du Cancer de Montpellier

Montpellier, Hérault, France, 34298

Actively Recruiting

2

CHU Clermont-Ferrand

Clermont-Ferrand, Puy De Dôme, France, 63000

Not Yet Recruiting

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Research Team

A

Aurore MOUSSION, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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