Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas (LYMPHOTEQ)
Primary Purpose
Cutaneous Lymphoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biologic Samples
Sponsored by
About this trial
This is an interventional other trial for Cutaneous Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Age> 18 years old
- Informed consent signed by the patient
- Suspicion of primary cutaneous lymphoma or confirmed lymphoma according to WHO/ISCL/EORTC criteria
Exclusion Criteria:
- Patient under guardianship or curatorship
- Lack of affiliation to social security
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with primary cutaneous lymphoma
Arm Description
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Progression free survival
Progression free survival
Overall survival
Full Information
NCT ID
NCT04520529
First Posted
August 17, 2020
Last Updated
August 17, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04520529
Brief Title
Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas
Acronym
LYMPHOTEQ
Official Title
Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2020 (Anticipated)
Primary Completion Date
September 30, 2045 (Anticipated)
Study Completion Date
September 30, 2050 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cutaneous lymphomas are a heterogeneous group of extra-nodal lymphomas. The prognosis of cutaneous lymphomas is extremely variable from one subject to another. In the majority of cases, there is no cure for cutaneous lymphomas. Cutaneous lymphomas primarily affect the skin, and secondarily the blood, lymph nodes and possibly other organs. The discovery of new molecular prognostic factors will allow a better identification of patients at high risk of aggressive evolution and the implementation of a personalized therapeutic strategy. The identification of new therapeutic targets is necessary in order to develop new innovative treatments for cutaneous lymphomas.The primary objective is to identify novel molecular prognostic factors associated with 5-year overall survival in cutaneous lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Lymphoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with primary cutaneous lymphoma
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Biologic Samples
Intervention Description
An additional punch from lesion skin as part of a skin biopsy performed as part of routine care.
an additional blood sample will be collected for research during a blood test performed as part of the patient's routine care.
In patients with clinical superficial lymphadenopathy or detected by imaging, and undergoing a superficial lymph node biopsy as part of the care, a core biopsy will be dedicated to research.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
5 years
Title
Progression free survival
Time Frame
10 years
Title
Overall survival
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age> 18 years old
Informed consent signed by the patient
Suspicion of primary cutaneous lymphoma or confirmed lymphoma according to WHO/ISCL/EORTC criteria
Exclusion Criteria:
Patient under guardianship or curatorship
Lack of affiliation to social security
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adèle DE MASSON
Phone
01 42 49 43 19
Email
adele.demasson@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu RESCHE-RIGON
Phone
0142499742
Ext
0142499742
Email
matthieu.resche-rigon@univ-paris-diderot.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas
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