NCT03280394

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Sep 2017Dec 2027

Study Start

First participant enrolled

September 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

10.3 years

First QC Date

September 6, 2017

Last Update Submit

October 31, 2023

Conditions

Mature B-Cell Neoplasm

Keywords

Liquid biopsyClassical Hodgkin LymphomaDiffuse Large B Cell LymphomaFollicular LymphomaMantle Cell LymphomaMutations

Outcome Measures

Primary Outcomes (4)

  • Accuracy of interim plasma cell free DNA genotyping for cHL patients

    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

    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

    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

    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

Interventions

Liquid BiopsyDIAGNOSTIC_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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Research

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes)

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, Mantle-Cell

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingInvestigative Techniques

Study Officials

  • Davide Rossi, MD, PhD

    Oncology Institute of Southern Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide Rossi, MD, PhD

CONTACT

+41 091 811 8540davide.rossi@eoc.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 12, 2017

Study Start

September 1, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

CH(1)