Clinical trial · Observational
Circulating Tumor DNA in Peripheral T-cell Lymphomas
Next-Generation Sequencing-based, Tumor- and Plasma-informed Droplet Digital PCR Assay for Detection of Circulating Tumor DNA in Peripheral T-cell Lymphomas
NCT06362148CI-TRIAL-00110112CIRCULATEactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NK/T-Cell Lymphoma | — | UNRESOLVED | — |
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) | Diagnostic Test | — | UNRESOLVED |
| Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- ctDNA occurrence
- timeFrame
- Up to 27 months
- description
- 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.
- measure
- ctDNA quantification
- timeFrame
- Up to 27 months
- description
- 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.
Secondary outcomes (6)
- measure
- Progression free survival
- timeFrame
- Up to 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.