Cell-free Circulating DNA in Primary Cutaneous Lymphomas (MATULILA)

• ClinicalTrials.gov Identifier: NCT02883517
• Recruitment Status: Unknown
• First Posted: August 30, 2016
• Last Update Posted: February 23, 2017
• Sponsor: University Hospital, Bordeaux
• Information provided by (Responsible Party): University Hospital, Bordeaux

Study Description

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.

Condition or disease	Intervention/treatment
Mycosis Fungoides; Lymphoma, Large B-cell, Diffuse	Genetic: Cytogenetic and molecular studies

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Detection of Somatic Mutations on Cell-free Circulating DNA in Potentially Aggressive Cutaneous Lymphomas
• Actual Study Start Date: November 2016
• Estimated Primary Completion Date: September 2018
• Estimated Study Completion Date: September 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Genetic: Cytogenetic and molecular studies; Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy [ Time Frame: Day 1 ]
2. Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy [ Time Frame: Week 12 ]
3. Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy [ Time Frame: Week 24 ]
4. Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy [ Time Frame: Week 36 ]

Secondary Outcome Measures :

1. Amount of circulating tumor DNA (number of copies / µl) [ Time Frame: Day 1 ]
2. Amount of free circulating DNA (number of copies / µl) [ Time Frame: Day 1 ]
3. Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone [ Time Frame: Day 1 ]
4. Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone [ Time Frame: Week 12 ]
5. Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone [ Time Frame: Week 24 ]
6. Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone [ Time Frame: Week 36 ]
7. Number of patient with presence or absence of mutation identified in circulating blood [ Time Frame: Day 1 ]
8. Number of patient with presence or absence of mutation identified in circulating blood [ Time Frame: Week 12 ]
9. Number of patient with presence or absence of mutation identified in circulating blood [ Time Frame: Week 24 ]
10. Number of patient with presence or absence of mutation identified in circulating blood [ Time Frame: Week 36 ]

Biospecimen Retention:   Samples With DNA

a collection of plasma collected at different times during the management of patients with aggressive cutaneous lymphomas followed at the University Hospital of Bordeaux.

Collection of tumor tissue biopsies for Next Generation Sequencing analysis

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patient with an aggressive cutaneous Lymphomas

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.

Contacts and Locations

Contacts

Contact: Anne PHAM-LEDARD, MD; +335 56 79 47 05; anne.pham-ledard@chu-bordeaux.fr

Contact: Christine ALFARO; +335 56 79 49 52; christine.alfaro@chu-bordeaux.fr

Locations

France

University Hospital of Bordeaux - Hospital Saint André; Recruiting

Bordeaux, France, 33000

Contact: Anne PHAM-LEDARD, MD +335 56 79 49 52 anne.pham-ledard@chu-bordeaux.fr

Contact: Christine ALFARO +335 56 79 49 52 christine.alfaro@chu-bordeaux.fr

Principal Investigator: Anne PHAM-LEDARD, MD

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

• Principal Investigator: Anne PHAM-LEDARD, MD; University Hospital, Bordeaux

More Information

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT02883517 History of Changes
• Other Study ID Numbers: CHUBX2015/35
• First Posted: August 30, 2016
• Last Update Posted: February 23, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University Hospital, Bordeaux:

cell-free circulating DNA; digital PCR; liquid biopsy

Additional relevant MeSH terms:

Mycoses; Lymphoma; Mycosis Fungoides; Lymphoma, Large B-Cell, Diffuse; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell