Prognostic Significance of ctDNA in HL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prognostic Cancer Model. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma
Overview
Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age \<60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy.
Detailed description
Samples of plasma from peripheral blood will be taken for investigational ctDNA examination during the specific timepoints: at diagnosis, after 2 cycles of initial chemotherapy, at the end of chemotherapy, 3 months after radiotherapy, at the diagnosis of the first relapse, after salvage chemotherapy before ASCT, 3 months after ASCT, at the diagnosis of second relapse and every 3 months during brentuximab vedotin treatment or during nivolumab treatment until progression. The buccal swab for germline DNA extraction will be performed at the time of enrollment into the study. Samples of peripheral blood for EBV-DNA analysis will be obtained from the EBV-positive cHL patients to measure EBV load at the same time-points as ctDNA. Microdissected HRS cells from fresh frozen biopsies at the diagnosis and at the relapse will be used for tumor cells next generation sequencing.
Primary outcome measures
- Identification of tumor specific mutation profiles at dg. of HL based on ctDNA [Time frame: 4 years]
- Quantitative analysis of ctDNA level during the first-line chemotherapy [Time frame: 4 years]
- Identification of tumor specific mutation profiles at relapse of classical HL [Time frame: 4 years]
Secondary outcome measures (1)
- In vitro functional characterization of identified DNA variants and/or mutations [Time frame: 4 years]
Eligibility criteria
Inclusion criteria
- Patients ≥ 18 years with newly histologically confirmed classical Hodgkin lymphoma (cHL) will be enrolled
- signing the informed consent
Exclusion criteria
- Pacients without signing the informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
Czechia · 5 centers
- University Hospital Hradec Kralove — Hradec Králové
- University Hospital Olomouc — Olomouc
- University Hospital Kralovske Vinohrady — Prague
- Charles University — Prague
- General University Hospital — Prague
Publications
- Dusek L, Majek O. Editorial. Klin Onkol. 2014;27 Suppl 2:3. No abstract available. PMID 25629123
- Mocikova H, Sykorova A, Stepankova P, Markova J, Michalka J, Kral Z, Buresova L, Belada D. [Treatment and prognosis of relapsed or refractory Hodgkin lymphoma patients ineligible for stem cell transplantation]. Klin Onkol. 2014;27(6):424-8. doi: 10.14735/amko2014424. Czech. PMID 25493581
- Sykorova A, Mocikova H, Lukasova M, Koren J, Stepankova P, Prochazka V, Belada D, Klaskova K, Gaherova L, Chroust K, Buresova L, Markova J; Czech Hodgkin's Lymphoma Study Group. Outcome of elderly patients with classical Hodgkin's lymphoma. Leuk Res. 2020 Mar;90:106311. doi: 10.1016/j.leukres.2020.106311. Epub 2020 Jan 24. PMID 32050133
Identifiers
NCT: NCT06263530 · NU22-03-00182