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NCT Number: NCT03280394

Liquid Biopsy in Mature B-cell Tumors

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.

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Key information

Conditions

Mature B-Cell Neoplasm Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Oncology Research

Bellinzona, Canton Ticino, 6500, Switzerland

Location status: Recruiting

Location contact

Davide Rossi, MD, PhD

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid Biopsy

Diagnostic Test

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Davide Rossi, MD, PhD

CONTACT

[email protected]

+41 091 811 8540

Sponsors and collaborators

Lead sponsor

Oncology Institute of Southern Switzerland

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Sep 12, 2017
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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