Mycosis FungoidesMATULILANCT02883517
Cell-free Circulating DNA in Primary Cutaneous Lymphomas
An observational study of Mycosis Fungoides and Lymphoma, Large B-cell, Diffuse, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides, Lymphoma, Large B-cell, Diffuse
- What is being tested?
- Cytogenetic and molecular studies
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2016to 16 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with an aggressive cutaneous Lymphomas
Who may be able to join
- 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.
Who cannot join
- Another cancer (except "in situ" and surgery treated cutaneous carcinomas) in the precedent 5 years.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Bordeaux - Hospital Saint André
Bordeaux, 33000
About this study
Official title: Detection of Somatic Mutations on Cell-free Circulating DNA in Potentially Aggressive 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.
Read the 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.
- Conditions
- Mycosis Fungoides, Lymphoma, Large B-cell, Diffuse
- Being tested
- Cytogenetic and molecular studies
- Keywords
- cell-free circulating DNA;, digital PCR, liquid biopsy
- Medical subject headings
- Mycosis Fungoides, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytogenetic and molecular studiesGenetic
Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Cytogenetic and molecular studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
Measured: Day 1
Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
Measured: Week 12
Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
Measured: Week 24
Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
Measured: Week 36
Secondary outcomes (10)
Amount of circulating tumor DNA (number of copies / µl)
Measured: Day 1
Amount of free circulating DNA (number of copies / µl)
Measured: Day 1
Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
Measured: Day 1
Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
Measured: Week 12
Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
Measured: Week 24
Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
Measured: Week 36
Number of patient with presence or absence of mutation identified in circulating blood
Measured: Day 1
Number of patient with presence or absence of mutation identified in circulating blood
Measured: Week 12
Number of patient with presence or absence of mutation identified in circulating blood
Measured: Week 24
Number of patient with presence or absence of mutation identified in circulating blood
Measured: Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start22 Nov 2016
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne PHAM-LEDARD, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883517
- Sponsor's protocol ID
- CHUBX2015/35
- Acronym
- MATULILA
- Status last verified
- May 2022
- First submitted
- 25 Aug 2016
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Somatic Mutations on Cell-free Circulating DNA in Potentially Aggressive Cutaneous Lymphomas
- ClinicalTrials.gov ID
- NCT02883517
- Acronym / sponsor ID
- MATULILA / CHUBX2015/35
- Conditions
- Mycosis Fungoides, Lymphoma, Large B-cell, Diffuse
- Keywords
- cell-free circulating DNA;, digital PCR, liquid biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aggressive primary cutaneous lymphomas | – | Genetic: Cytogenetic and molecular studies* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an aggressive cutaneous Lymphomas
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Another cancer (except "in situ" and surgery treated cutaneous carcinomas) in the precedent 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytogenetic and molecular studiesDetect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome. | Genetic | Aggressive primary cutaneous lymphomas |
Primary 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
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne PHAM-LEDARD, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycosis Fungoides and Lymphoma, Large B-cell, Diffuse, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022; AzTrials last refreshed its copy on 29 Oct 2026.