Tracing Dissemination of Melanoma Cells in Healthy Tissues

  • STATUS
    Recruiting
  • End date
    Oct 27, 2023
  • participants needed
    214
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 27 April 2021
BRAF
KIT
NRAS
metastasis

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.

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.

Details
Condition melanoma, skin cancer, Metastatic Melanoma, Malignant Melanoma
Treatment Melanoma and peritumoral skin excision
Clinical Study IdentifierNCT02854124
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: skin cancer or melanoma?
Do you have any of these conditions: Malignant Melanoma or melanoma or Metastatic Melanoma or skin cancer?
Do you have any of these conditions: Metastatic Melanoma or melanoma or Malignant Melanoma or skin cancer?
Do you have any of these conditions: Malignant Melanoma or melanoma or Metastatic Melanoma or skin cancer?
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
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