NCT04520529

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
297mo left

Started Sep 2020

Longer than P75 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Sep 2020Sep 2050

First Submitted

Initial submission to the registry

August 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
25 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2045

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2050

Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

25 years

First QC Date

August 17, 2020

Last Update Submit

August 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • overall survival

    5 years

Secondary Outcomes (3)

  • Progression free survival

    5 years

  • Progression free survival

    10 years

  • Overall survival

    10 years

Study Arms (1)

Patients with primary cutaneous lymphoma

OTHER
Other: Biologic Samples

Interventions

* 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.

Patients with primary cutaneous lymphoma

Eligibility Criteria

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

You may qualify if:

  • Age\> 18 years old
  • Informed consent signed by the patient
  • Suspicion of primary cutaneous lymphoma or confirmed lymphoma according to WHO/ISCL/EORTC criteria

You may not qualify if:

  • Patient under guardianship or curatorship
  • Lack of affiliation to social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 20, 2020

Study Start

September 30, 2020

Primary Completion (Estimated)

September 30, 2045

Study Completion (Estimated)

September 30, 2050

Last Updated

August 20, 2020

Record last verified: 2020-08