Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma
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
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Nice、フランス、06202
- Chu De Nice
-
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Metastatic melanoma patients
Sampling of blood before and after chemotherapy
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7,5 ml of blood
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measuring the number of circulating melanoma cells/ml in blood
時間枠：baseline and 3 months
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Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.
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baseline and 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test
時間枠：3 months
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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.
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3 months
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|
Difference in survival
時間枠：baseline and 6 months
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Difference in survival between patients depending on the number of circulating melanoma cells/ml before treatment, according to Kaplan-Meier method.
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baseline and 6 months
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Difference in tumor response
時間枠：6 months
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Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.
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6 months
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協力者と研究者
捜査官
- スタディディレクター：Damien GIACCHERO, PH、Centre Hospitalier Universitaire De Nice
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。