NCT05254821

Cell-free Tumor DNA as Minimal Residual Disease in Hodgkin Lymphoma Patients

Cell-free Tumor DNA Analysis for Minimal Residual Disease Detection in Patients With Hodgkin Lymphoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Molecular analysis identifies residual disease by overcoming the sensitivity of imaging methods and therefore has the potential for integrating with therapy provided by FDG-PET alone. It is a well known fact that tumor DNA circulating in plasma (ctDNA) reflects the mutational profile of tumor cells and can be used to non-invasively detect specific mutations of Hodgkin's lymphoma without the need for microdissecting the histological sample.

Detailed description

A clinical need, not yet met for the Hodgkin lymphoma disease, brings about the early and accurate identification of chemo-refractory patients who require stepping up of treatment as also, patients with good prognosis receiving treatment de-escalation.Molecular methods identify residual disease by overcoming the sensitivity of imaging methods and therefore have the potential to integrate the response to therapy provided by FDG-PET alone. ctDNA modification from the basal time point to the interim can be used as a predictor of response to the ABVD scheme and as a complement to the interim-PET in the possible variation of the therapeutic schedule. Clinical data and peripheral blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes) will be collected during the clinico/laboratory visits that are planned as per clinical routine at the time of diagnosis, at each cycle of chemotherapy, at the time of interim PET/CT, at the time of end of treatment PET/CT and during follow up.

Conditions

• Hodgkin Lymphoma

Timeline

• Start date: 2022-01-10
• Primary completion: 2024-02-03
• Completion: 2026-02-03
• First posted: 2022-02-24
• Last updated: 2022-11-14

Locations

1 site across 1 country: Italy