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

  • STATUS
    Recruiting
  • End date
    Feb 3, 2026
  • participants needed
    130
  • sponsor
    Federico II University
Updated on 10 March 2022
lymphoma

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.

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.

Details
Condition Hodgkin Lymphoma
Clinical Study IdentifierNCT05254821
SponsorFederico II University
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

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)
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