Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer
NCT ID: NCT06181201
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2 participants
OBSERVATIONAL
2024-01-19
2024-10-08
Brief Summary
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Detailed Description
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* the gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) on the one hand, and
* 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.
Primary endpoint: The primary endpoint will be complete histological response assessed on the surgical specimen after the neoadjuvant therapy regimen. This assessment will be performed according to the usual standards and blinded to any information on the gut microbiota and on the content of short-chain fatty acids and tryptophan derivatives.
Secondary objectives:
* To explore the profile of gut microbiota composition and short-chain fatty acid content in the two groups of patients (complete histological response or not), assessed before any treatment (T0).
* To assess the changes in the composition of the intestinal flora and the content of short chain fatty acids following treatment with induction chemotherapy (T1), then preoperative radiochemotherapy (T2) if applicable, by comparison of the preoperative sample with the initial sample (T0).
* Assess the association between these taxonomic and metabolic changes (T1-T0, T2-T0) on the one hand and the histological response on the other.
* To evaluate the association between the profile of the composition of the intestinal microbiota and the content of short-chain fatty acids, as well as calprotectin (a reliable and sensitive non-invasive marker of intestinal inflammation) assessed before any treatment (T0) on the one hand, and the occurrence of toxicity during treatment, in particular digestive toxicity.
Secondary endpoints:
* Percentage of different bacteria or families of bacteria (abundance) such as Ruminococcaceae in the intestinal flora and dosage of short-chain fatty acids;
* Rarefaction curves;
* Taxonomic indicators;
* Alpha and beta diversity indices of microbiota composition;
* Determination of calprotectin by ELISA on stool sample.
* Toxicity assessed by collecting adverse events during treatment with FOLFIRINOX and for some patients during radiochemotherapy, graded according to the NCI CTCAE v5 scale and classified according to the MEDDRA dictionary;
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Stool collection
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
Interventions
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Stool collection
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
L'Institut des sciences moléculaires (iSm2 UMR CNRS 7313)
UNKNOWN
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Mathias CHAMAILLARD
Role: STUDY_DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Mehrdad JAFARI
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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Centre Oscar Lambret
Lille, , France
Countries
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Other Identifiers
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N° Id RCB: 2022-A00572-41
Identifier Type: OTHER
Identifier Source: secondary_id
NéoFloRect-2201
Identifier Type: -
Identifier Source: org_study_id