Lymphoma, Large B-cell, Diffuse Clinical Trial
— MATULILAOfficial title:
Detection of Somatic Mutations on Cell-free Circulating DNA in Potentially Aggressive Cutaneous Lymphomas
Verified date | May 2022 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To evaluate the possibility of detecting cell-free circulating tumoral DNA in potentially aggressive primary cutaneous lymphomas, the investigator opted to search a representative tumor sample mutation in the blood of these patients, by digital PCR. Patients with mycosis fungoides, primary cutaneous T-cell lymphoma helper follicular phenotype and primary cutaneous diffuse large B-cell lymphoma, leg-type will be included and 4 blood samples will be collected during 12 months.
Status | Completed |
Enrollment | 35 |
Est. completion date | December 16, 2019 |
Est. primary completion date | December 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age > 18 years; - French social security system affiliation or equivalent; - Patient with an aggressive cutaneous lymphoma (PCDLBCL-LT, mycosis fungoides, T helper follicular cutaneous lymphoma) diagnosed and monitored at the university hospital of Bordeaux; - Written and informed consent obtained for genetic blood test; - Biopsy sample available for molecular analysis. Exclusion Criteria: - Another cancer (except "in situ" and surgery treated cutaneous carcinomas) in the precedent 5 years. |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Bordeaux - Hospital Saint André | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy | Day 1 | ||
Primary | Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy | Week 12 | ||
Primary | Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy | Week 24 | ||
Primary | Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy | Week 36 | ||
Secondary | Amount of circulating tumor DNA (number of copies / µl) | Day 1 | ||
Secondary | Amount of free circulating DNA (number of copies / µl) | Day 1 | ||
Secondary | Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone | Day 1 | ||
Secondary | Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone | Week 12 | ||
Secondary | Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone | Week 24 | ||
Secondary | Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone | Week 36 | ||
Secondary | Number of patient with presence or absence of mutation identified in circulating blood | Day 1 | ||
Secondary | Number of patient with presence or absence of mutation identified in circulating blood | Week 12 | ||
Secondary | Number of patient with presence or absence of mutation identified in circulating blood | Week 24 | ||
Secondary | Number of patient with presence or absence of mutation identified in circulating blood | Week 36 |
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