Peripheral T Cell LymphomaPTCL-SEQNCT06089941
Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas
An observational study of Peripheral T Cell Lymphoma, run by Centre Henri Becquerel at 1 site in France.
Trial summary
The purpose of this study is to assess the feasibility of analyzing circulating tumor DNA (ctDNA) as a biomarker using the shallow whole genome sequencing (lpWGS) technique coupled with deep sequencing of a targeted panel of genes (NGS), in a population of patients with newly diagnosed or relapsed/refractory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- circulating tumoral DNA detection
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 4 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 newly or relapse/refractory peripheral T Cell Lymphoma
Who may be able to join
- Aged 18 or over
- Newly diagnosed or relapsed/refractory peripheral T-cell lymphoma (PTCL), including T/NK lymphoma (NKTL)
- Pre-therapeutic FDG PET-CT already performed
- Signed informed consent
- Patients affiliated with or beneficiaries of a health insurance plan
Who cannot join
- Cutaneous T-cell lymphomas without systemic involvement
- Pregnant or breastfeeding women
- For newly diagnosed patients: patient who has already started the first systemic treatment for their lymphoma (apart from pre-phase corticosteroid therapy which is authorized)
- For patients in a relapsed/refractory situation: Patient who has already started the new specific line of lymphoma treatment planned for the current relapsed/refractory situation (apart from pre-phase corticosteroid therapy which is authorized)
- Lack of patient consent
- Patient whose weight is less than 30 kg
- Protected adult or deprived of freedoms (under guardianship or curatorship)
- Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographic problem, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Circulating Tumor DNA Sequencing in Peripheral T-cell Lymphomas
The purpose of this study is to assess the feasibility of analyzing circulating tumor DNA (ctDNA) as a biomarker using the shallow whole genome sequencing (lpWGS) technique coupled with deep sequencing of a targeted panel of genes (NGS), in a population of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma (PTCL).
Read the detailed description
Peripheral T-cell lymphomas (PTCL) are a rare and heterogeneous group of diseases resulting from the clonal proliferation of mature post-thymic lymphocytes. These T-cell neoplasms account for approximately 10-15% of all lymphomas and patients with these lymphomas have among the worst 5-year relative survivals (36%-56%, depending on prognostic factors). There are no biomarkers validated in PTCL.
Low pass whole genome sequencing (lpWGS) is an innovative molecular biology technique capable of detecting variations in the number of gene copies in patients' blood, which is a reflection of the quantity of tumor cells in the patient, lymphoma cells carrying numerous gains and deletions of certain genes at the somatic level. lpWGS is inexpensive, requires small quantities of DNA, targets the entire genome, is less time-consuming than other techniques for studying ctDNA and preliminary data in lymphomas have shown the interest of this technique. The investigators hypothesize that this study of ctDNA in PTCL will be relevant, sensitive and very informative for monitoring patients with the lpWGS technique combined with a panel of genes targeted in depth by NGS that the investigators propose to implement. This is a multicenter, prospective study, based on biological samples and clinical and imaging data to be collected.
This study will be offered to each patient suffering from PTCL, including T/NK lymphomas (NKTL) with systemic involvement (excluding cutaneous T-cell lymphomas) having an indication for systemic treatment.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- circulating tumoral DNA detection
- Keywords
- peripheral T Cell Lymphoma, Next generation sequencing, circulating tumor DNA, Low-pass whole genome sequencing
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circulating tumoral DNA detectionOther
blood samples taken at diagnosis, mid-treatment, end of treatment and in the event of relapse
| Study group | Role | What they receive |
|---|---|---|
| Detection of circulating tumoral DNA | Blood assessment to detect circultating tumoral DNA Receives: Other: circulating tumoral DNA detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of ctDNA assessement
rate of patients considered informative (i.e. patient with at least one detectable mutation from ctDNA analysis by lpWGS and/or targeted NGS). The main objective will be achieved if the proportion of informative results is at least 90%.
Measured: at the inclusion
Feasibility of ctDNA assessement
rate of patients considered informative (i.e. patient with at least one detectable mutation from ctDNA analysis by lpWGS and/or targeted NGS). The main objective will be achieved if the proportion of informative results is at least 90%.
Measured: 8 weeks
Feasibility of ctDNA assessement
rate of patients considered informative (i.e. patient with at least one detectable mutation from ctDNA analysis by lpWGS and/or targeted NGS). The main objective will be achieved if the proportion of informative results is at least 90%.
Measured: 16 weeks
Secondary outcomes (4)
Concordance between ctDNA and tumor mutational profile
Description of the concordance between the mutational profile on the tumor and on plasma ctDNA at diagnosis and at relapse
Measured: at the inclusion
Progression free survival
Time beetween inclusion and progression
Measured: one year
Overal survival
Time beetween inclusion and death
Measured: one year
Imaging assessment by PET-CT
Description of metabolic tumor volume before treatment, and therapeutic response (based on Lugano 2014 criteria) end of treatment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jan 2024
- Primary completion4 Nov 2025
- Study completion4 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Collaborators
- IDEOGEN
- Responsible party
- Sponsor
- Investigators
- Vincent Camus, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089941
- Sponsor's protocol ID
- CHB23.03
- Acronym
- PTCL-SEQ
- Status last verified
- Feb 2026
- First submitted
- 9 Oct 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Circulating Tumor DNA Sequencing in Peripheral T-cell Lymphomas
- ClinicalTrials.gov ID
- NCT06089941
- Acronym / sponsor ID
- PTCL-SEQ / CHB23.03
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- peripheral T Cell Lymphoma, Next generation sequencing, circulating tumor DNA, Low-pass whole genome sequencing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Collaborators
- IDEOGEN
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- 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.
The purpose of this study is to assess the feasibility of analyzing circulating tumor DNA (ctDNA) as a biomarker using the shallow whole genome sequencing (lpWGS) technique coupled with deep sequencing of a targeted panel of genes (NGS), in a population of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma (PTCL).
Detailed description
Peripheral T-cell lymphomas (PTCL) are a rare and heterogeneous group of diseases resulting from the clonal proliferation of mature post-thymic lymphocytes. These T-cell neoplasms account for approximately 10-15% of all lymphomas and patients with these lymphomas have among the worst 5-year relative survivals (36%-56%, depending on prognostic factors). There are no biomarkers validated in PTCL.
Low pass whole genome sequencing (lpWGS) is an innovative molecular biology technique capable of detecting variations in the number of gene copies in patients' blood, which is a reflection of the quantity of tumor cells in the patient, lymphoma cells carrying numerous gains and deletions of certain genes at the somatic level. lpWGS is inexpensive, requires small quantities of DNA, targets the entire genome, is less time-consuming than other techniques for studying ctDNA and preliminary data in lymphomas have shown the interest of this technique. The investigators hypothesize that this study of ctDNA in PTCL will be relevant, sensitive and very informative for monitoring patients with the lpWGS technique combined with a panel of genes targeted in depth by NGS that the investigators propose to implement. This is a multicenter, prospective study, based on biological samples and clinical and imaging data to be collected.
This study will be offered to each patient suffering from PTCL, including T/NK lymphomas (NKTL) with systemic involvement (excluding cutaneous T-cell lymphomas) having an indication for systemic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Detection of circulating tumoral DNA | – | Other: circulating tumoral DNA detectionBlood assessment to detect circultating tumoral DNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with newly or relapse/refractory peripheral T Cell Lymphoma
Key inclusion criteria (5 listed)
- Aged 18 or over
- Newly diagnosed or relapsed/refractory peripheral T-cell lymphoma (PTCL), including T/NK lymphoma (NKTL)
- Pre-therapeutic FDG PET-CT already performed
- Signed informed consent
- Patients affiliated with or beneficiaries of a health insurance plan
Key exclusion criteria (8 listed)
- Cutaneous T-cell lymphomas without systemic involvement
- Pregnant or breastfeeding women
- For newly diagnosed patients: patient who has already started the first systemic treatment for their lymphoma (apart from pre-phase corticosteroid therapy which is authorized)
- For patients in a relapsed/refractory situation: Patient who has already started the new specific line of lymphoma treatment planned for the current relapsed/refractory situation (apart from pre-phase corticosteroid therapy which is authorized)
- Lack of patient consent
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 |
|---|---|---|
| circulating tumoral DNA detectionblood samples taken at diagnosis, mid-treatment, end of treatment and in the event of relapse | Other | Detection of circulating tumoral DNA |
Primary outcome
Feasibility of ctDNA assessement
Time frame: at the inclusion
rate of patients considered informative (i.e. patient with at least one detectable mutation from ctDNA analysis by lpWGS and/or targeted NGS). The main objective will be achieved if the proportion of informative results is at least 90%.
Feasibility of ctDNA assessement
Time frame: 8 weeks
rate of patients considered informative (i.e. patient with at least one detectable mutation from ctDNA analysis by lpWGS and/or targeted NGS). The main objective will be achieved if the proportion of informative results is at least 90%.
Feasibility of ctDNA assessement
Time frame: 16 weeks
rate of patients considered informative (i.e. patient with at least one detectable mutation from ctDNA analysis by lpWGS and/or targeted NGS). The main objective will be achieved if the proportion of informative results is at least 90%.
4 secondary outcomes
Concordance between ctDNA and tumor mutational profile
Time frame: at the inclusion
Progression free survival
Time frame: one year
Overal survival
Time frame: one year
Imaging assessment by PET-CT
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- 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.
Vincent Camus principal investigator
Centre Henri Becquerel
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 Peripheral T Cell Lymphoma, run by Centre Henri Becquerel 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 8 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of ctDNA assessement (time frame: at the inclusion). The study lists 3 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 20 Feb 2026.