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Cell-free Circulating DNA in Primary Cutaneous Lymphomas

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02883517
Acronym
MATULILA
Enrollment
35
Registered
2016-08-30
Start date
2016-11-22
Completion date
2019-12-16
Last updated
2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Large B-cell, Diffuse, Mycosis Fungoides

Keywords

cell-free circulating DNA;, digital PCR, liquid biopsy

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.

Interventions

GENETICCytogenetic and molecular studies

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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsyDay 1

Secondary

MeasureTime 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 cloneDay 1
Number of patient with presence or absence of mutation identified in circulating bloodDay 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026