Clinical trial NCT02883517: Cell-free Circulating DNA in Primary Cutaneous Lymphomas
Official title: Detection of Somatic Mutations on Cell-free Circulating DNA in Potentially Aggressive Cutaneous Lymphomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycosis Fungoides
Lymphoma, Large B-cell, Diffuse
Keywords: cell-free circulating DNA;
digital PCR
liquid biopsy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with an aggressive cutaneous Lymphomas

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.

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.

Primary outcomes:
measure: Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
timeFrame: Day 1
measure: Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
timeFrame: Week 12
measure: Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
timeFrame: Week 24
measure: Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
timeFrame: Week 36
Secondary outcomes:
measure: Amount of circulating tumor DNA (number of copies / µl)
timeFrame: Day 1
measure: Amount of free circulating DNA (number of copies / µl)
timeFrame: Day 1
measure: Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
timeFrame: Day 1
measure: Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
timeFrame: Week 12
measure: Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
timeFrame: Week 24
measure: Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
timeFrame: Week 36
measure: Number of patient with presence or absence of mutation identified in circulating blood
timeFrame: Day 1
measure: Number of patient with presence or absence of mutation identified in circulating blood
timeFrame: Week 12
measure: Number of patient with presence or absence of mutation identified in circulating blood
timeFrame: Week 24
measure: Number of patient with presence or absence of mutation identified in circulating blood
timeFrame: Week 36
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux - Hospital Saint André
Study officials:
affiliation: University Hospital, Bordeaux
name: Anne PHAM-LEDARD, MD
role: PRINCIPAL_INVESTIGATOR
References: