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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cutaneous Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 17, 2020
    Last Updated
    August 17, 2020
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    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

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    Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas

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