Trials Sponsors Conditions Drugs Pricing

Conditions

Lymphoma, Large B-cell, Diffuse Mycosis Fungoides

Keywords

cell-free circulating DNA;digital PCRliquid biopsy

Outcome Measures

Primary Outcomes (4)

Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
Day 1
Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
Week 12
Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
Week 24
Proportion of patients who have circulating free tumor DNA (detected by Digital polymerase chain reaction) with the mutation identified on biopsy
Week 36

Secondary Outcomes (10)

Amount of circulating tumor DNA (number of copies / µl)
Day 1
Amount of free circulating DNA (number of copies / µl)
Day 1
Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
Day 1
Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
Week 12
Number of patient with presence or absence of blood lymphocyte clone identical to the tumor clone
Week 24
+5 more secondary outcomes

Study Arms (1)

Aggressive primary cutaneous lymphomas

* Mycosis fungoides ≥ T2b * Primary cutaneous T helper follicular lymphoma ≥ T2 * Primary cutaneous diffuse large B-cell lymphoma, leg type Genetic: Cytogenetic and molecular studies Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.

Genetic: Cytogenetic and molecular studies

Interventions

Cytogenetic and molecular studiesGenetic

Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.

Aggressive primary cutaneous lymphomas

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Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patient with an aggressive cutaneous Lymphomas

You may qualify if:

age \> 18 years;

Sponsors & Collaborators

University Hospital, Bordeaux
Otherlead

Study Sites (1)

University Hospital of Bordeaux - Hospital Saint André

Bordeaux, 33000, France

Biospecimen

Retention: SAMPLES WITH DNA

a collection of plasma collected at different times during the management of patients with aggressive cutaneous lymphomas followed at the University Hospital of Bordeaux. Collection of tumor tissue biopsies for Next Generation Sequencing analysis

MeSH Terms

Conditions

Mycosis FungoidesLymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, CutaneousLymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Study Officials

Anne PHAM-LEDARD, MD
University Hospital, Bordeaux
PRINCIPAL INVESTIGATOR

Enrollment

35 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

November 22, 2016

Actual (reported)

Cell-free Circulating DNA in Primary Cutaneous Lymphomas

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (10)

Study Arms (1)

Aggressive primary cutaneous lymphomas

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (10)

Study Arms (1)

Aggressive primary cutaneous lymphomas

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations