Clinical trial NCT03280394: Liquid Biopsy in Mature B-cell Tumors
Official title: Prospective, Observational, Multi-centred, Non-interventional Research Project on Plasma Cell Free DNA Genotyping as a Tool to Inform Mature B-cell Tumor Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mature B-Cell Neoplasm
Keywords: Liquid biopsy
Classical Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Mutations
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female adults 18 years or older with a documented diagnosis of mature B-cell tumor according to WHO 2008 criteria

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).

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of interim plasma cell free DNA genotyping for cHL patients
timeFrame: 24 months from treatment
measure: Accuracy of interim plasma cell free DNA genotyping for DLBCL patients
timeFrame: 24 months from treatment
measure: Accuracy of interim plasma cell free DNA genotyping for FL patients
timeFrame: 24 months from treatment
measure: Accuracy of interim plasma cell free DNA genotyping for MCL patients
timeFrame: 24 months from treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Institute of Oncology Research
state: Tessin
Study officials:
affiliation: Oncology Institute of Southern Switzerland
name: Davide Rossi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: