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Liquid Biopsy in Mature B-cell Tumors

Sponsor
Oncology Institute of Southern Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT03280394
Collaborator
(none)
444
Enrollment
1
Location
124
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Liquid Biopsy

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 Design

Study Type:
Observational
Anticipated Enrollment :
444 participants
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
Actual Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 31, 2027

Outcome Measures

Primary Outcome Measures

  1. Accuracy of interim plasma cell free DNA genotyping for cHL patients [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Institute of Oncology Research Bellinzona Tessin Switzerland 6500

Sponsors and Collaborators

  • Oncology Institute of Southern Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Davide Rossi, MD, PhD, Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier:
NCT03280394
Other Study ID Numbers:
  • IOSI-EMA003
First Posted:
Sep 12, 2017
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
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, MD, PhD, 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

Study Results

No Results Posted as of Sep 9, 2021