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Trial record 6 of 2318 for:    melanoma

Molecular Characterization of Advanced Stage Melanoma by Blood Sampling (MELCIRC)

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ClinicalTrials.gov Identifier: NCT02862743
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.

In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.


Condition or disease Intervention/treatment
Metastatic Melanoma Other: patients with metastatic melanoma

Detailed Description:

The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.

The secondary objectives of this study will be:

  • Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
  • Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: patients with metastatic melanoma
patients with metastatic melanoma (stage III unresectable or stage IV)
Other: patients with metastatic melanoma
Blood sample to realize molecular characterization of melanoma


Outcome Measures

Primary Outcome Measures :
  1. Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood [ Time Frame: Day 0 ]
    Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel)


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • patient with melanoma confirmed histologically
  • patient with metastatic melanoma (stage III unresectable or stage IV)
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

Exclusion Criteria:

- Metastatic tumor whose origin is doubtful (uncertain melanoma)

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): NCT02862743


Contacts
Contact: Florent GRANGE fgrange@chu-reims.fr

Locations
France
Chu de Reims Recruiting
Reims, France, 51092
Contact: Florent GRANGE       fgrange@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
More Information

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02862743     History of Changes
Other Study ID Numbers: PO15097
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

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