Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer

NCT06181201 | Terminated

• 2 other identifiers: NéoFloRect-2202N° Id RCB: 2022-A00572-41
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational, single-centre study (RIPH3) for patients with rectal cancer soon to be treated with chemotherapy (+/- neo-adjuvant radio-chemotherapy) looking at the relationship between the composition of the gut microbiota before treatment and the tumour response after chemotherapy +/- radio-chemotherapy

Conditions

Cancer of Rectum

Outcome Measures

Primary Outcomes (2)

• Gut microbiota description at T0

  gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) Measurement of gut microbiota composition at T0 by high-throughput sequencing of the 16S subunit of bacterial ribosomes

  at baseline

• histological response according to Ryan classification

  complete histological response assessed on the surgical resection specimen in patients with histologically proven stage II and III rectal tumours treated with neo-adjuvant chemotherapy followed or not by Cap50 radiochemotherapy before surgery and according to Ryan classification. TRG (TRG0-TRG3) TRG 3: extensive residual cancer with no evident tumor regression (poor or not response

  after surgery, an average of 8 months after inclusion

Study Arms (1)

Person with rectal cancer

People with locally advanced rectal cancer who are to receive induction chemotherapy with FLOFIRINOX followed or not by neo-adjuvant radio-chemotherapy of the Cap50 type.

Procedure: Stool collection

Interventions

Stool collection PROCEDURE

Stool collection is done with the "Coll-off" device (Zymo research, reference R1101-2-5) provided to the patient before and after the induction treatment and after the reference chemo-radiotherapy treatment (Cap50, Capecitabine). Collection must be carried out by the patient at home (collection using the "Coll-off" device and then transfer to a coproculture jar provided). The fresh sample is then picked up the same day by an approved transporter mandated by the promoter and will be stored at -20°C until the start of the analyses

Person with rectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with locally advanced rectal cancer who are to receive induction chemotherapy with FLOFIRINOX followed or not by neo-adjuvant radio-chemotherapy of the Cap50 type

You may qualify if:

• Histologically proven stage II and III adenocarcinoma of the lower and middle rectum
• Patient undergoing preoperative treatment with induction chemotherapy (Folfirinox) followed or not by radio-chemotherapy of the Cap50 type
• Male or female patient aged 18 years or older
• Normal weight, overweight or moderately obese (BMI between 18.5 and 34.9)
• Patient residing in the Lille metropolitan area
• Patient affiliated to a French social protection scheme
• Patient having given his non-opposition

You may not qualify if:

• History of other concurrent cancers
• Presence of an intestinal (internal or external) or external urinary diversion
• Uncooperative patient for geographical, family, social or psychological reasons
• Limited legal capacity or legal incapacity

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• L'Institut des sciences moléculaires (iSm2 UMR CNRS 7313): collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, 59000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

stools

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mathias CHAMAILLARD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

• Mehrdad JAFARI

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 26, 2023
• Study Start: February 19, 2024
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)