JOURNAL ONKOLOGIE – STUDIE

Liquid Biopsy in Mature B-cell Tumors

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03280394

Studienbeginn:
September 2017

Letztes Update:
01.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lymphoma, B-Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Oncology Institute of Southern Switzerland

Collaborator:
-

Studienleiter

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

Kontakt

Davide Rossi, MD, PhD
Kontakt:
Phone: +41 091 811 8540
E-Mail: davide.rossi@eoc.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Institute of Oncology Research
6500 Bellinzona
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Davide Rossi, MD, PhD
E-Mail: davide.rossi@eoc.ch» Ansprechpartner anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

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