NCT04217382

Brief Summary

Melanoma incidence is increase in global population and number of transplantation also. However immunosuppressor increase recurrence risk of melanoma. There are more and more cases of eligible patients to transplant with an antecedent of melanoma. There is no guideline yet. Main objective is survival time without melanoma recurrence in this population to do guideline of time limit or not between melanoma and transplantation by stage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 27, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

December 30, 2019

Last Update Submit

December 9, 2021

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

  • survival time without melanoma recurrence

    Delay in recurrence-free survival since diagnosis and since transplantation

    at enrollment

Interventions

patient with melanoma pre transplantationOTHER

survival time without melanoma recurrence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient with an antecedent of melanoma before transplantation

You may qualify if:

  • patient with an antecedent of melanoma before transplantation
  • Not opposite to participate

You may not qualify if:

  • Under the age of 18
  • patient under Guardianship
  • patient not affiliated with a health system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

service de dermatologie - hopital Edouard Herriot

Lyon, Rhone, 69003, France

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Emilie DUCROUX, MD

    Service de Dermatologie, Hôpital Edouard Herriot, Lyon

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 3, 2020

Study Start

February 27, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

December 10, 2021

Record last verified: 2021-12

Locations

FR(1)