Pre Transplantation Melanoma | NCT04217382

Studies
Pre Transplantation Melanoma

NCT04217382

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Dec 10, 2021Actual

Enrollment

37Actual

Phase

Not provided

Conditions

Malignant Melanoma

Interventions

patient with melanoma pre transplantation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2020Actual

Primary Completion Date

Aug 31, 2020Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Dec 30, 2019

First Submission Date that Met QC Criteria

Jan 2, 2020

First Posted Date

Jan 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2021

Last Update Posted Date

Dec 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
patient with melanoma pre transplantation	Other	survival time without melanoma recurrence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival time without melanoma recurrence	Delay in recurrence-free survival since diagnosis and since transplantation	at enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient with an antecedent of melanoma before transplantation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emilie DUCROUX, MD	Service de Dermatologie, Hôpital Edouard Herriot, Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
service de dermatologie - hopital Edouard Herriot		Lyon	Rhone	69003	France

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided