Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181201
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2022-12-06
Brief Title:
Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
Association Between the Composition of the Intestinal Microbiota Before Treatment and the Tumor Response After Induction Chemotherapy Followed or Not by Neo-adjuvant Radio-chemotherapy in Locally Advanced Rectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Neo-Flo-Rect
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
Detailed Description:
Main objective The main objective is to test the association between
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N Id RCB 2022-A00572-41 | OTHER | ANSM | None |