Cell-free Circulating DNA in Primary Cutaneous Lymphomas

Lymphoma, Large B-cell, Diffuse Clinical Trial

— MATULILA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883517
• Other study ID #: CHUBX2015/35
• Status: Completed
• Start date: November 22, 2016
• Est. completion date: December 16, 2019

Study information

• Verified date: May 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-cell, Diffuse
• Mycoses
• Mycosis Fungoides

Intervention

Genetic:
• Cytogenetic and molecular studies
Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.

Locations

Country	Name	City	State
France	University Hospital of Bordeaux - Hospital Saint André	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy		Day 1
Primary	Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy		Week 12
Primary	Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy		Week 24
Primary	Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy		Week 36
Secondary	Amount of circulating tumor DNA (number of copies / µl)		Day 1
Secondary	Amount of free circulating DNA (number of copies / µl)		Day 1
Secondary	Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone		Day 1
Secondary	Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone		Week 12
Secondary	Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone		Week 24
Secondary	Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone		Week 36
Secondary	Number of patient with presence or absence of mutation identified in circulating blood		Day 1
Secondary	Number of patient with presence or absence of mutation identified in circulating blood		Week 12
Secondary	Number of patient with presence or absence of mutation identified in circulating blood		Week 24
Secondary	Number of patient with presence or absence of mutation identified in circulating blood		Week 36