Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT05602168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-11-01
First Post:
2022-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance
Sponsor:
Institut Paoli-Calmettes
Organization:
Study Overview
Official Title:
Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance: HEMATOBIO.02-IPC 2021-061
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-10
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:
None
Brief Summary:
The main objective is to study the genomic, transcriptomic, proteomic epigenomic, metabolomic and immune mechanisms of blasts and microenvironment cells associated with IT resistance through the constitution of a collection associating blood or marrow samples from patients with LA, MDS and MPS marrow samples from patients with LA, MDS and MPS at diagnosis, during treatment and at relapse and relapse and clinical annotations.
Detailed Description:
It is a collection of blood, marrow and oral epithelial cell samples taken longitudinally and oral epithelial cells taken longitudinally for each patient included, with each patient included, with the corresponding clinical data. An oral epithelial cell sample will be collected at inclusion from 2 swabs, which will allow extraction of DNA from healthy from healthy cells. During blood sampling necessary for care, an additional 40 ml of blood will be collected of 40 ml of blood will be collected in 10 tubes of 4 ml: 4 EDTA tubes, 4 heparinized heparinized tubes and 2 dry tubes. These additional collections will take place at the following times:
* At inclusion
* 7 days (+/- 2 days) after initiation of treatment
* 14 days (+/- 2 days) after initiation of therapy
* 21-42 days after initiation of therapy (early response assessment)
* In case of complete remission
* In case of relapse or progression During bone marrow punctures required for treatment, 6 ml of bone marrow bone marrow will be collected in 2 tubes of 3 ml: 1 EDTA tube and 1 heparinized tube.
heparinized tube. These additional collections will take place at the following times following times:
* At inclusion
* 21-42 days after initiation of treatment (assessment of early response) early response)
* In case of complete remission
* In case of relapse or progression Patients will be followed for up to 2 years after inclusion.
* At inclusion
* 7 days (+/- 2 days) after initiation of treatment
* 14 days (+/- 2 days) after initiation of therapy
* 21-42 days after initiation of therapy (early response assessment)
* In case of complete remission
* In case of relapse or progression During bone marrow punctures required for treatment, 6 ml of bone marrow bone marrow will be collected in 2 tubes of 3 ml: 1 EDTA tube and 1 heparinized tube.
heparinized tube. These additional collections will take place at the following times following times:
* At inclusion
* 21-42 days after initiation of treatment (assessment of early response) early response)
* In case of complete remission
* In case of relapse or progression Patients will be followed for up to 2 years after inclusion.
Study Oversight
Has Oversight DMC:
False
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?: