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NCT Number: NCT01573494

Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma

Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma.

Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma.

Secondary objectives:

* determine the percentage of patients with metastatic melanoma with melanoma cells circulating * seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma * seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma

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Key information

Conditions

Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Cells, Circulating Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06202, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > or = 18 years
  • Patients with advanced melanoma stage IIIC (unresectable) or stage IV
  • Patient not treated or not responding to chemotherapy with chemotherapy session last> 1 month
  • Patients who signed informed consent
  • Patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology
  • Patients with a life expectancy greater than 3 months
  • Patients with melanoma measurable by RECIST version 1.1
  • Patients with venous good for venipuncture

Exclusion criteria

  • Patients with contraindication for treatment with chemotherapy or V600E BRAF inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma
  • Pregnant women or nursing
  • People vulnerable detainees, adults under guardianship or curatorship, minors.

Treatment and study plan

Sampling of blood

Other

7,5 ml of blood

Primary outcomes

  1. Measuring the number of circulating melanoma cells/ml in blood

    Time frame: baseline and 3 months

    Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.

Secondary outcomes

  1. number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test

    Time frame: 3 months

    Calculating the number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test before and after treatment.

  2. Difference in survival

    Time frame: baseline and 6 months

    Difference in survival between patients depending on the number of circulating melanoma cells/ml before treatment, according to Kaplan-Meier method.

  3. Difference in tumor response

    Time frame: 6 months

    Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 9, 2012
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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