Cell-free Circulating DNA in Primary Cutaneous Lymphomas

NCT02883517 | Completed

• 1 other identifier: CHUBX2015/35
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycosis Fungoides; Lymphoma, Large B-cell, Diffuse

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

Study Arms (1)

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

Interventions

Cytogenetic and molecular studies GENETIC

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

Aggressive primary cutaneous lymphomas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with an aggressive cutaneous Lymphomas

You may qualify if:

• 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.

You may not qualify if:

• Another cancer (except "in situ" and surgery treated cutaneous carcinomas) in the precedent 5 years.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital of Bordeaux - Hospital Saint André

Bordeaux, 33000, France

Location

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

MeSH Terms

Conditions

Mycosis Fungoides; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Study Officials

• Anne PHAM-LEDARD, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: November 22, 2016
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)