Liquid Biopsy in Mature B-cell Tumors

October 31, 2023 updated by: Davide Rossi, Oncology Institute of Southern Switzerland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Estimated)

444

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Tessin
      • Bellinzona, Tessin, Switzerland, 6500
        • Recruiting
        • Institute of Oncology Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of interim plasma cell free DNA genotyping for cHL patients
Time Frame: 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)
24 months from treatment
Accuracy of interim plasma cell free DNA genotyping for DLBCL patients
Time Frame: 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)
24 months from treatment
Accuracy of interim plasma cell free DNA genotyping for FL patients
Time Frame: 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
24 months from treatment
Accuracy of interim plasma cell free DNA genotyping for MCL patients
Time Frame: 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
24 months from treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncology Institute of Southern Switzerland

Investigators

  • Principal Investigator: Davide Rossi, MD, PhD, Oncology Institute of Southern Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOSI-EMA003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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