Liquid Biopsy in Mature B-cell Tumors

Mature B-Cell Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03280394
• Other study ID #: IOSI-EMA003
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Oncology Institute of Southern Switzerland
• Contact: Davide Rossi, MD, PhD
• Phone: +41 091 811 8540
• Email: davide.rossi[@]eoc.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 444
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma, B-Cell
• Mature B-Cell Neoplasm

Intervention

Diagnostic Test:
• Liquid Biopsy
Assessing whether plasma cell free DNA improves 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, at disease presentation, refine the diagnostic workup in mature B-cell tumor patients and, upon treatment, early identify the emergence of resistance mutations.

Locations

Country	Name	City	State
Switzerland	Institute of Oncology Research	Bellinzona	Tessin

Sponsors (1)

Lead Sponsor	Collaborator
Oncology Institute of Southern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of interim plasma cell free DNA genotyping for cHL patients	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)	24 months from treatment
Primary	Accuracy of interim plasma cell free DNA genotyping for DLBCL patients	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)	24 months from treatment
Primary	Accuracy of interim plasma cell free DNA genotyping for FL patients	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	24 months from treatment
Primary	Accuracy of interim plasma cell free DNA genotyping for MCL patients	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	24 months from treatment