Cell-free Circulating DNA in Primary Cutaneous Lymphomas (MATULILA)
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ClinicalTrials.gov Identifier: NCT02883517 |
Recruitment Status :
Completed
First Posted : August 30, 2016
Last Update Posted : May 13, 2022
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Condition or disease | Intervention/treatment |
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Mycosis Fungoides Lymphoma, Large B-cell, Diffuse | Genetic: Cytogenetic and molecular studies |
Study Type : | Observational |
Actual Enrollment : | 35 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 22, 2016 |
Actual Primary Completion Date : | December 16, 2019 |
Actual Study Completion Date : | December 16, 2019 |

Group/Cohort | Intervention/treatment |
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Aggressive primary cutaneous lymphomas
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Genetic: Cytogenetic and molecular studies
Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome. |
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Amount of circulating tumor DNA (number of copies / µl) [ Time Frame: Day 1 ]
- Amount of free circulating DNA (number of copies / µl) [ Time Frame: Day 1 ]
- Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone [ Time Frame: Day 1 ]
- Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone [ Time Frame: Week 12 ]
- Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone [ Time Frame: Week 24 ]
- Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone [ Time Frame: Week 36 ]
- Number of patient with presence or absence of mutation identified in circulating blood [ Time Frame: Day 1 ]
- Number of patient with presence or absence of mutation identified in circulating blood [ Time Frame: Week 12 ]
- Number of patient with presence or absence of mutation identified in circulating blood [ Time Frame: Week 24 ]
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883517
France | |
University Hospital of Bordeaux - Hospital Saint André | |
Bordeaux, France, 33000 |
Principal Investigator: | Anne PHAM-LEDARD, MD | University Hospital, Bordeaux |
Responsible Party: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT02883517 |
Other Study ID Numbers: |
CHUBX2015/35 |
First Posted: | August 30, 2016 Key Record Dates |
Last Update Posted: | May 13, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
cell-free circulating DNA; digital PCR liquid biopsy |
Mycoses Lymphoma Mycosis Fungoides Lymphoma, Large B-Cell, Diffuse Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bacterial Infections and Mycoses Infections Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoma, B-Cell |