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Liquid Biopsy in Mature B-cell Tumors

This study is currently recruiting participants.
Verified September 2017 by Davide Rossi, Oncology Institute of Southern Switzerland
Sponsor:
ClinicalTrials.gov Identifier:
NCT03280394
First Posted: September 12, 2017
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Davide Rossi, Oncology Institute of Southern Switzerland
  Purpose
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.

Condition Intervention
Mature B-Cell Neoplasm Diagnostic Test: Liquid Biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Davide Rossi, Oncology Institute of Southern Switzerland:

Primary Outcome Measures:
  • 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)

  • 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)

  • 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

  • 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


Biospecimen Retention:   Samples With DNA
Blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes)

Estimated Enrollment: 444
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: December 31, 2027
Estimated Primary Completion Date: December 31, 2027 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280394


Contacts
Contact: Davide Rossi, MD, PhD +41 091 811 8540 davide.rossi@eoc.ch

Locations
Switzerland
Institute of Oncology Research Recruiting
Bellinzona, Tessin, Switzerland, 6500
Contact: Davide Rossi, MD, PhD       davide.rossi@eoc.ch   
Sponsors and Collaborators
Oncology Institute of Southern Switzerland
Investigators
Principal Investigator: Davide Rossi, MD, PhD Oncology Institute of Southern Switzerland
  More Information

Responsible Party: Davide Rossi, MD, PhD, Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier: NCT03280394     History of Changes
Other Study ID Numbers: IOSI-EMA003
First Submitted: September 6, 2017
First Posted: September 12, 2017
Last Update Posted: September 12, 2017
Last Verified: September 2017

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

Keywords provided by Davide Rossi, Oncology Institute of Southern Switzerland:
Liquid biopsy
Classical Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Mutations

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases