NCT02854124

Brief Summary

The objective of this project is to evaluate the presence of melanoma quiescent or initiating clonal cells in peritumoral healthy tissue displaying the same molecular signature than those of the tumor/metastasis and to correlate this presence to the prognostic value.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 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

July 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

4.1 years

First QC Date

July 31, 2016

Last Update Submit

November 17, 2025

Conditions

Melanoma

Keywords

MelanomaDisseminationInitiating stem cells

Outcome Measures

Primary Outcomes (1)

  • Survival at 5 years

    correlation to the presence of tumoral initiating stem cells in healthy tissues

    5 years

Secondary Outcomes (1)

  • Survival at 5 years without tumor recurrence

    5 years

Study Arms (1)

Patients with stage Ib and II melanoma

Melanoma and peritumoral skin excision

Procedure: Melanoma and peritumoral skin excision

Interventions

Melanoma and peritumoral skin excisionPROCEDURE

Surgical retrieval of the primary tumor and safety retrieval of the surrounding normal peritumoral skin and sentinel lymph node

Patients with stage Ib and II melanoma

Eligibility Criteria

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

Patients with stage Ib and II melanoma followed in the parisian cohort Melan-cohort, Cochin Hospital and Gustave Roussy Institute included between 2005 and 2009

You may qualify if:

  • Men and women age \> 18 years old.
  • Primary melanomas stage Ib and II.
  • Melanomas mutated BRAF, NRAS, c-kit.
  • Cutaneous melanomas.

You may not qualify if:

  • Metastatic melanomas stage III and IV.
  • Melanomas with invasion of the peritumoral skin tissue.
  • Congenital or acquired immunosuppression.
  • Antitumoral, immunosuppressive treatments or any other diseases during the follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Name:: INSERM - UMRS 938, UPMC Saint-Antoinen Hospital, Team "Stem cells and transition from pre-invasive tumors"

Paris, Paris, 75012, France

Location

Related Publications (4)

  • Curtin JA, Fridlyand J, Kageshita T, Patel HN, Busam KJ, Kutzner H, Cho KH, Aiba S, Brocker EB, LeBoit PE, Pinkel D, Bastian BC. Distinct sets of genetic alterations in melanoma. N Engl J Med. 2005 Nov 17;353(20):2135-47. doi: 10.1056/NEJMoa050092.

    PMID: 16291983BACKGROUND

  • Faries MB, Steen S, Ye X, Sim M, Morton DL. Late recurrence in melanoma: clinical implications of lost dormancy. J Am Coll Surg. 2013 Jul;217(1):27-34; discussion 34-6. doi: 10.1016/j.jamcollsurg.2013.03.007. Epub 2013 May 3.

    PMID: 23643694BACKGROUND

  • Quintana E, Shackleton M, Sabel MS, Fullen DR, Johnson TM, Morrison SJ. Efficient tumour formation by single human melanoma cells. Nature. 2008 Dec 4;456(7222):593-8. doi: 10.1038/nature07567.

    PMID: 19052619BACKGROUND

  • How-Kit A, Tost J. Pyrosequencing(R)-Based Identification of Low-Frequency Mutations Enriched Through Enhanced-ice-COLD-PCR. Methods Mol Biol. 2015;1315:83-101. doi: 10.1007/978-1-4939-2715-9_7.

    PMID: 26103893BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Primary melanoma, sentinel lymph node and peritumoral skin tissu

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

  • Romain Fontaine, PhD

    INSERM - UMRS 938

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 3, 2016

Study Start

October 12, 2017

Primary Completion

November 12, 2021

Study Completion

November 12, 2021

Last Updated

November 20, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)