Cell-free Circulating DNA in Primary Cutaneous Lymphomas

NCT ID: NCT02883517

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-22
• Study Completion Date: 2019-12-16

Brief Summary

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.

Detailed 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.

Conditions

Mycosis Fungoides; Lymphoma, Large B-cell, Diffuse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Aggressive primary cutaneous lymphomas

• 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.

Cytogenetic and molecular studies

Intervention Type: GENETIC

Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.

Interventions

Cytogenetic and molecular studies

Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.

Intervention Type: GENETIC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne PHAM-LEDARD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

University Hospital of Bordeaux - Hospital Saint André

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX2015/35

Identifier Type: -

Identifier Source: org_study_id