Peripheral T-cell LymphomaCIRCULATENCT06362148
Circulating Tumor DNA in Peripheral T-cell Lymphomas
An observational study of Peripheral T-cell Lymphoma and NK/T-Cell Lymphoma, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate the feasibility of circulating tumor DNA (ctDNA) measurement in blood plasma for the applicability in prognostication, treatment evaluation and measurable residual disease (MRD) surveillance in a cohort of patients with newly diagnosed or relapsed/refractory peripheral T-cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma, NK/T-Cell Lymphoma
- What is being tested?
- Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay and 18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT)
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2024to Dec 2030
- How long will I take part?
- 5 Years
- 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: Patients with peripheral T-cell lymphomas managed at tertiary care hospitals in Denmark.
Who may be able to join
- Patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma.
- All primary systemic PTCL entities from the International Consensus Classification 2022.
- ≥18 years of age.
- Life expectancy of 3 months or longer.
- ECOG performance status 0-4 at study entry (PS4 only if lymphoma-induced).
- Measurable disease.
- Written informed consent.
Who cannot join
- T-cell prolymphocytic leukemia
- T-cell large granular lymphocytic leukemia
- Chronic lymphoproliferative disorder of NK cells
- Adult T-cell leukemia / lymphoma
- Aggressive NK-cell leukemia
- Primary cutaneous T-cell lymphoma such as Sézary syndrome and Mycosis fungoides.
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- Primary cutaneous CD30 positive T-cell lymphoproliferative disorders.
- Lymphomatoid papulosis.
- Primary cutaneous anaplastic large cell lymphoma.
- Primary cutaneous small/medium CD4-positive T-cell lymphoproliferative disorder.
- Primary cutaneous gamma-delta T-cell lymphoma.
- Primary cutaneous acral CD8-positive T-cell lymphoproliferative disorder.
- Primary cutaneous CD8-positive aggressive epidermotropic cytotoxic T-cell lymphoma.
- History of active cancer during the past year, except basal cell carcinoma of the skin or stage 0 cervical carcinoma (in situ).
- Unwillingness or inability to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hematology, Aarhus University Hospital
Aarhus, Central Jutland, 8200
About this study
Official title: Next-Generation Sequencing-based, Tumor- and Plasma-informed Droplet Digital PCR Assay for Detection of Circulating Tumor DNA in Peripheral T-cell Lymphomas
The aim of this study is to evaluate the feasibility of circulating tumor DNA (ctDNA) measurement in blood plasma for the applicability in prognostication, treatment evaluation and measurable residual disease (MRD) surveillance in a cohort of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphomas (PTCL).
Read the detailed description
In this observational prospective cohort study the investigators want to test the use of minimal-invasive liquid biopsies (blood plasma) for the detection of ctDNA in patients with newly diagnosed or relapsed/refractory PTCL. In each enrolled patient a diagnostic tumor-containing tissue biopsy as well as a baseline plasma sample will be subject to targeted next-generation sequencing (NGS) with the aim of identifying tumor-specific genetic alterations and clonal T-cell receptor rearrangements. This testing will be performed on biopsies that have been obtained as a part of standard-of-care diagnostic evaluation for PTCL and no further invasive biopsies will be performed.
Based on the NGS-analysis, a droplet digital polymerase chain reaction (ddPCR) assay will be designed for each patient. ddPCR will be used to detect ctDNA in plasma at diagnosis and later at defined time points during treatment and in the follow-up period.
At the same defined time points PET/CT scans will be performed for later comparative analysis. PTCL patients routinely have PET/CT scans performed before the start of treatment, mid-treatment, at the end of treatment and after hematopoietic stem cell transplant when applicable. PET/CT scans will be conducted every 6 months for the first 2 years of routine follow-up.
Active patient participation (i.e. blood sampling for ctDNA analysis and PET/CT scans) is expected to last up to 27 months from inclusion. Follow-up for survival analysis will be done for up to 5 years from inclusion.
The investigators hypothesize that the NGS-based tumor- and plasma-informed ddPCR assay applied in this study, will provide a highly sensitive and specific tool for prognostication, response evaluation and detection of relapse in patients with PTCL.
- Conditions
- Peripheral T-cell Lymphoma, NK/T-Cell Lymphoma
- Being tested
- Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay, 18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT)
- Keywords
- Liquid biopsy, Circulating Tumor DNA, ctDNA, Cell Free DNA, cfDNA, mutational profiling
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assayDiagnostic test
Blood sampling for circulating tumor DNA analysis at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of induction/end of treatment, 100 day follow-up, 6 month, 12 month, 18 month and 24 month follow-up. Blood sampling will also be done in case of relapsing/refractory disease at any point prior to the abovementioned time points.
18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT)Diagnostic test
FDG-PET/CT performed at baseline, mid-treatment, end of induction/end of treatment and 6 month, 12 month, 18 month and 24 month follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA occurrence
Proportion of patients with one or more measurable genetic alterations detected in plasma ctDNA by a tumor-informed, NGS-based patient-specific droplet digital PCR assay at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of treatment, 6 month, 12 month, 18 month and 24 month follow-up.
Measured: Up to 27 months
ctDNA quantification
Median ctDNA levels in plasma by a tumor- and plasma-informed, NGS-based patient-specific droplet digital PCR assay at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of treatment, 6 month, 12 month, 18 month and 24 month follow-up.
Measured: Up to 27 months
Secondary outcomes (6)
Progression free survival
Time from date of diagnosis until the date of disease progression or relapse or death from any cause, whichever occurred first.
Measured: Up to 5 years
Overall survival
Time from date of diagnosis to the date of death from any cause or the date of last follow-up. Patients who are event-free at their last follow-up evaluation will be censored at that time point.
Measured: Up to 5 years
Radiographic assessment by PET/CT
Description of tumor staging, metabolic tumor volume and total lesion glycolysis by 18F-fludeoxyglucose positron emission tomography/computed tomography (PET/CT) before treatment. Therapeutic response evaluation based on the 2014 Lugano classification criteria at mid-treatment, end of treatment, 6 month, 12 month, 18 month and 24 month follow-up.
Measured: Up to 27 months
Comparison of molecular and radiographic response
Concordance between detection of ctDNA (MRD-positive or MRD-negative) and therapeutic response assessed by PET/CT at mid-treatment, end of treatment, 6 month, 12 month, 18 month and 24 month follow-up.
Measured: Up to 27 months
Spatial and temporal mutational homo- or heterogeneity
Characterization of the con- or discordance between the genetic profile in tumor and plasma ctDNA at diagnosis and at relapse.
Measured: Up to 27 months
Fragment pattern analysis
Description of fragment sizes of ctDNA by capillary electrophoresis at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of treatment, 6 month, 12 month, 18 month and 24 month follow-up.
Measured: Up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2030 (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
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Francesco A d'Amore, MD, DMSc, Study chair, Aarhus University Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362148
- Sponsor's protocol ID
- 1-10-72-134-23
- Acronym
- CIRCULATE
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2024
- Last updated
- 1 May 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next-Generation Sequencing-based, Tumor- and Plasma-informed Droplet Digital PCR Assay for Detection of Circulating Tumor DNA in Peripheral T-cell Lymphomas
- ClinicalTrials.gov ID
- NCT06362148
- Acronym / sponsor ID
- CIRCULATE / 1-10-72-134-23
- Conditions
- Peripheral T-cell Lymphoma, NK/T-Cell Lymphoma
- Keywords
- Liquid biopsy, Circulating Tumor DNA, ctDNA, Cell Free DNA, cfDNA, mutational profiling
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Apr 2024 (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 aim of this study is to evaluate the feasibility of circulating tumor DNA (ctDNA) measurement in blood plasma for the applicability in prognostication, treatment evaluation and measurable residual disease (MRD) surveillance in a cohort of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphomas (PTCL).
Detailed description
In this observational prospective cohort study the investigators want to test the use of minimal-invasive liquid biopsies (blood plasma) for the detection of ctDNA in patients with newly diagnosed or relapsed/refractory PTCL. In each enrolled patient a diagnostic tumor-containing tissue biopsy as well as a baseline plasma sample will be subject to targeted next-generation sequencing (NGS) with the aim of identifying tumor-specific genetic alterations and clonal T-cell receptor rearrangements. This testing will be performed on biopsies that have been obtained as a part of standard-of-care diagnostic evaluation for PTCL and no further invasive biopsies will be performed.
Based on the NGS-analysis, a droplet digital polymerase chain reaction (ddPCR) assay will be designed for each patient. ddPCR will be used to detect ctDNA in plasma at diagnosis and later at defined time points during treatment and in the follow-up period.
At the same defined time points PET/CT scans will be performed for later comparative analysis. PTCL patients routinely have PET/CT scans performed before the start of treatment, mid-treatment, at the end of treatment and after hematopoietic stem cell transplant when applicable. PET/CT scans will be conducted every 6 months for the first 2 years of routine follow-up.
Active patient participation (i.e. blood sampling for ctDNA analysis and PET/CT scans) is expected to last up to 27 months from inclusion. Follow-up for survival analysis will be done for up to 5 years from inclusion.
The investigators hypothesize that the NGS-based tumor- and plasma-informed ddPCR assay applied in this study, will provide a highly sensitive and specific tool for prognostication, response evaluation and detection of relapse in patients with PTCL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral T-cell lymphomas managed at tertiary care hospitals in Denmark.
Key inclusion criteria (7 listed)
- Patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma.
- All primary systemic PTCL entities from the International Consensus Classification 2022.
- ≥18 years of age.
- Life expectancy of 3 months or longer.
- ECOG performance status 0-4 at study entry (PS4 only if lymphoma-induced).
Key exclusion criteria (15 listed)
- T-cell prolymphocytic leukemia
- T-cell large granular lymphocytic leukemia
- Chronic lymphoproliferative disorder of NK cells
- Adult T-cell leukemia / lymphoma
- Aggressive NK-cell leukemia
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 |
|---|---|---|
| Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assayBlood sampling for circulating tumor DNA analysis at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of induction/end of treatment, 100 day follow-up, 6 month, 12 month, 18 month and 24 month follow-up. Blood sampling will also be done in case of relapsing/refractory disease at any point prior to the abovementioned time points. | Diagnostic test | – |
| 18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT)FDG-PET/CT performed at baseline, mid-treatment, end of induction/end of treatment and 6 month, 12 month, 18 month and 24 month follow-up. | Diagnostic test | – |
Primary outcome
ctDNA occurrence
Time frame: Up to 27 months
Proportion of patients with one or more measurable genetic alterations detected in plasma ctDNA by a tumor-informed, NGS-based patient-specific droplet digital PCR assay at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of treatment, 6 month, 12 month, 18 month and 24 month follow-up.
ctDNA quantification
Time frame: Up to 27 months
Median ctDNA levels in plasma by a tumor- and plasma-informed, NGS-based patient-specific droplet digital PCR assay at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of treatment, 6 month, 12 month, 18 month and 24 month follow-up.
6 secondary outcomes
Progression free survival
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Radiographic assessment by PET/CT
Time frame: Up to 27 months
Comparison of molecular and radiographic response
Time frame: Up to 27 months
Spatial and temporal mutational homo- or heterogeneity
Time frame: Up to 27 months
Fragment pattern analysis
Time frame: Up to 27 months
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 1 May 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.
Francesco A d'Amore, MD, DMSc study chair
Aarhus University Hospital and Aarhus University
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 and NK/T-Cell Lymphoma, run by University of Aarhus at 1 site in Denmark.
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 7 inclusion and 15 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 1 May 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 Denmark. 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?
ctDNA occurrence (time frame: Up to 27 months). The study lists 2 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 1 May 2026.