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Trial record 3 of 2318 for:    melanoma

Tracing Dissemination of Melanoma Cells in Healthy Tissues (DISSEMELA)

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ClinicalTrials.gov Identifier: NCT02854124
Recruitment Status : Not yet recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Melanoma Procedure: Melanoma and peritumoral skin excision

Detailed Description:

In the western world, melanoma incidence has constantly risen for the last 50 years, and it is currently reported as the most frequent tumor in 20 - 29 year old women. BRAF, NRAS and c-kit genes play an important role in cell proliferation and are mutated at very high frequency in melanoma. Despite the recent therapeutical breakthroughs obtained with the use of new drugs, metastatic melanoma remains still a life threatening disease. One of the main questions in melanoma concern the initial steps leading to metastatic spread, a better understanding being a key step to its prevention and the identification of new molecular mechanisms being implemental to the improvement of our therapeutical arsenal.

The proposed work aims to study the hypothesis of early spread in human melanoma using the recently developed powerful techniques of e-ice cold PCR, as well as classical immunohistochemistry. To do so, investigators will take advantage on the fact that treatment of melanoma relies on a secondary excision of normal peritumoral skin and sentinel lymph node. This peritumoral tissue is large (measuring 2 to 6 cm diameter), contains lymphatics in the hypodermis, the tissue considered to host the metastatic route of melanocytes and remains partially available for analysis.

All 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 will be found. A PCR analysis will be done on DNA extracted from paraffin embedded sections of primary tumors. Patients who display mutations in BRAF (BRAFV600E, BRAFV600K), NRAS (codon 61) or c-kit genes will be selected. The archival paraffin embedded tissues from healthy perilesional skin as well as from healthy sentinel lymph nodes will be obtained. Pyrosequencing and e-ice cold PCR targeting the mutations of the above genes at their usual positions will be done on DNA extracted from these specimens. Immunofluorescence anti-BRAFV600E or anti tumoral/initiating/stem cells will be done on same tissues. These simple techniques will test -using a sensitive molecular biology tool- whether in humans with melanomas, there is early dissemination of melanoma cells in histopathological healthy sentinel lymph node and peritumoral skin. The presence of these clonal cells in these healthy tissues will be correlated to the survival of the patients after 5 years and will allow the development of new therapeutic follow-up and strategies.


Study Design

Study Type : Observational
Estimated Enrollment : 214 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Melanoma Cells Dissemination Study in Healthy Patients' Tissues
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients with stage Ib and II melanoma
Melanoma and peritumoral skin excision
Procedure: Melanoma and peritumoral skin excision
Surgical retrieval of the primary tumor and safety retrieval of the surrounding normal peritumoral skin and sentinel lymph node


Outcome Measures

Primary Outcome Measures :
  1. Survival at 5 years [ Time Frame: 5 years ]
    correlation to the presence of tumoral initiating stem cells in healthy tissues


Secondary Outcome Measures :
  1. Survival at 5 years without tumor recurrence [ Time Frame: 5 years ]
    correlation to the presence of tumoral initiating stem cells in healthy tissues


Biospecimen Retention:   Samples With DNA
Primary melanoma, sentinel lymph node and peritumoral skin tissu

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854124


Contacts
Contact: Selim Aractingi, MD, PhD +33140011465 selim.aractingi@gmail.com
Contact: Valérie Fauroux +33 1 58 41 12 13 valerie.fauroux@aphp.fr

Locations
France
Name:: INSERM - UMRS 938, UPMC Saint-Antoinen Hospital, Team "Stem cells and transition from pre-invasive tumors" Not yet recruiting
Paris, France, 75012
Contact: Romain Fontaine, PhD    +33140011465    romain.fontaine@inserm.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Romain Fontaine, PhD INSERM - UMRS 938
More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02854124     History of Changes
Other Study ID Numbers: NI15020
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Melanoma
Dissemination
Initiating stem cells

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas