Cell-free Circulating DNA in Primary Cutaneous Lymphomas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Detection of Somatic Mutations on Cell-free Circulating DNA in Potentially Aggressive Cutaneous Lymphomas

Conditions
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Mycosis Fungoides, Lymphoma, Large B-cell, Diffuse

Intervention / Treatment
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* Genetic: Cytogenetic and molecular studies


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aggressive primary cutaneous lymphomas<br>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. | Genetic: Cytogenetic and molecular studies<br>* Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy |  | Day 1 | 
| Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy |  | Week 12 | 
| Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy |  | Week 24 | 
| Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy |  | Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of circulating tumor DNA (number of copies / µl) |  | Day 1 | 
| Amount of free circulating DNA (number of copies / µl) |  | Day 1 | 
| Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone |  | Day 1 | 
| Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone |  | Week 12 | 
| Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone |  | Week 24 | 
| Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone |  | Week 36 | 
| Number of patient with presence or absence of mutation identified in circulating blood |  | Day 1 | 
| Number of patient with presence or absence of mutation identified in circulating blood |  | Week 12 | 
| Number of patient with presence or absence of mutation identified in circulating blood |  | Week 24 | 
| Number of patient with presence or absence of mutation identified in circulating blood |  | Week 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cell-free circulating DNA;, digital PCR, liquid biopsy