Prospective, Observational, Multi-centred, Non-interventional Research Project on Plasma Cell Free DNA Genotyping as a Tool to Inform Mature B-cell Tumor Management

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    444
  • sponsor
    Oncology Institute of Southern Switzerland
Updated on 18 October 2022

Summary

The study aims at assessing whether cell free DNA genotyping can improve the accuracy of early prediction of cure in mature B-cell tumor patients and whether it represents an accessible source of tumor DNA for the sensitive identification of genetic biomarkers that refine the diagnostic workup, stratify prognosis and identify the emergence of drug-resistance mutations during treatment.

Description

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 mature B-cell tumor diagnosis, before treatment, at the time of interim PET/CT, at the time of end of treatment PET/CT and at the time of disease relapse.

Clinical variables, international prognostic index, results of plasma cell free DNA genotyping and of PET-CT will be analyzed descriptively.

The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of the compiled results of plasma cell free DNA genotyping and interim PET-CT (for cHL and DLBCL), or plasma cell free DNA genotyping and baseline international prognostic index (for FL and MCL) in identifying patients that are progression free for >24 months after first line therapy will be calculated and compared with those obtained by the sole interim PET-CT (cHL and DLBCL) or the sole international prognostic index (FL, MCL).

Details
Condition Mature B-Cell Neoplasm
Treatment Liquid Biopsy
Clinical Study IdentifierNCT03280394
SponsorOncology Institute of Southern Switzerland
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female adults 18 years or older
Documented diagnosis of mature B-cell tumor according to WHO 2008 criteria
Willing and able to comply with scheduled study procedures
Evidence of a signed informed consent
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