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Completed

NCT Number: NCT02883517

Cell-free Circulating DNA in Primary Cutaneous Lymphomas

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Bordeaux - Hospital Saint André

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cytogenetic and molecular studies

Genetic

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: MATULILA

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2016
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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