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Trial Title:
Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance
NCT ID:
NCT05602168
Condition:
Hematologic Cancer
Conditions: Official terms:
Hematologic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
the study is interventional because there are blood samples taken outside the scope of
routine care
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
experimental:Acute leukemia/myelodysplastic or myeloproliferative disease
Description:
blood sampling, bone marrow aspirate and buccal swab
Arm group label:
experimental:Acute leukemia/myelodysplastic or myeloproliferative disease
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosis of acute leukemia, myelodysplastic syndrome, chronic myelomonocytic
leukemia (CMML) or myeloproliferative syndrome according to the WHO classification
2016,
2. Patient for whom a new line of therapy is initiated.
3. Patient older than 18 years of age.
4. Patient affiliated to the social security system or benefiting from such a system.
5. Signed consent to participate.
Exclusion Criteria:
1. Weight at inclusion < 50 kg
2. Participating in another clinical study that would cause the total amount of blood
collection to exceed the and endanger the patient
3. Person in an emergency situation, adult under legal protection (guardianship,
curatorship, etc.) protection (guardianship, curatorship or safeguard of justice),
or unable to express his or her consent.
4. Impossibility to submit to the medical follow-up of the trial for geographical
social or psychological reasons,
5. Pregnant or breastfeeding women
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 2023
Completion date:
January 2030
Lead sponsor:
Agency:
Institut Paoli-Calmettes
Agency class:
Other
Source:
Institut Paoli-Calmettes
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05602168
