NCT06263530

Prognostic Significance of ctDNA in HL

Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Interni hematologicka klinika FNKV · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Prognostic Cancer Model

Timeline

• Start date: 2022-01-02
• Primary completion: 2023-12-31
• Completion: 2027-12-31
• First posted: 2024-02-16
• Last updated: 2024-02-16

Locations

5 sites across 1 country: Czechia