Liquid Biopsy in Mature B-cell Tumors

Recruiting

• Conditions: Mature B-Cell Neoplasm

• Registration Number: NCT03280394
• Lead Sponsor: Oncology Institute of Southern Switzerland

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 444

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of interim plasma cell free DNA genotyping for MCL patients	24 months from treatment	Assessment of interim plasma cell free DNA genotyping accuracy in the identification of patients in continuous complete remission at 24 months from first line treatment vs patients not in continuous complete remission at 24 months from first line treatment in MCL
Accuracy of interim plasma cell free DNA genotyping for cHL patients	24 months from treatment	Assessment of interim plasma cell free DNA genotyping accuracy in the identification of cured vs non cured patients in cHL (patients not progressed after 24 months)
Accuracy of interim plasma cell free DNA genotyping for FL patients	24 months from treatment	Assessment of interim plasma cell free DNA genotyping accuracy in the identification of patients in continuous complete remission at 24 months from first line treatment vs patients not in continuous complete remission at 24 months from first line treatment in FL and other indolent B-cell lymphoproliferative disorders
Accuracy of interim plasma cell free DNA genotyping for DLBCL patients	24 months from treatment	Assessment of interim plasma cell free DNA genotyping accuracy in the identification of cured vs non cured patients in DLBCL (patients not progressed after 24 months)

Trial Locations

Locations (1)

Institute of Oncology Research; 🇨🇭 Bellinzona, Tessin, Switzerland