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Cell-free Circulating DNA in Primary Cutaneous Lymphomas (MATULILA)

U

University Hospital of Bordeaux

Status

Completed

Conditions

Mycosis Fungoides
Lymphoma, Large B-cell, Diffuse

Treatments

Genetic: Cytogenetic and molecular studies

Study type

Observational

Funder types

Other

Identifiers

NCT02883517
CHUBX2015/35

Details and patient eligibility

About

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.

Full description

Primary cutaneous lymphomas represent the second extra nodal localization of lymphomas, and are constituted by T-cell and B-cell phenotype lymphomas. Mycosis fungoides, a T-cell epidermotropic lymphoma, is the most frequent. Its clinical behavior is usually indolent but some patients have an aggressive evolution. Among B-cell cutaneous lymphomas, primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL-LT) is the most aggressive. Cytogenetic and molecular studies on these tumours led to a genetic characterization of these entities. Therefore, there is not any biologic marker that can help monitoring these lymphomas. In solid tumors, mutations exhibited by the tumour tissue has been detected in plasma of patients, assessing the possibility to detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome. The concept of liquid biopsies, allowing the detection of tumour mutation in plasma has been validated in nodal diffuse large B-cell lymphoma. That's why the purpose is to evaluate the possibility to detect cell-free circulating tumoral DNA in primary cutaneous lymphomas, using a highly sensitive method (digital PCR), combined with a next generation sequencing panel of the tumour sample.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

35 participants in 1 patient group

Aggressive primary cutaneous lymphomas
Description:
* Mycosis fungoides ≥ T2b * Primary cutaneous T helper follicular lymphoma ≥ T2 * Primary cutaneous diffuse large B-cell lymphoma, leg type Genetic: Cytogenetic and molecular studies Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.
Treatment:
Genetic: Cytogenetic and molecular studies

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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