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

Recruiting

• Conditions: Hodgkin Lymphoma

• Registration Number: NCT05254821
• Lead Sponsor: Federico II University

Brief 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.

Study Timeline

• Study Start: 2022-01-10
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14
• Primary Completion: 2024-02-03
• Study Completion: 2026-02-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Male or female adults 18 years or older
• Documented diagnosis of Hodgkin lymphoma (both classic and nodular predominant lymphocytes subtype) according to 2016 WHO classification
• Willing and able to comply with scheduled study procedures
• Evidence of a signed informed consent
• ECOG performance status 0-2 (or 3, if disease related)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of interim ctDNA genotyping	24 months	Sensitivity of interim ctDNA genotyping in identifying chemorefractory patients or patients with good prognosis (patients who do not progress after 24 months)

Trial Locations

Locations (1)

Federico II University; 🇮🇹 Naples, Italy