Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer
Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment with erlotinib.
PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ECOG-E3503.
- Determine the loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients.
- Assess whether mesenchymal and epithelial markers are predictive of progression-free survival (PFS) of these patients.
- Identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS of these patients.
OUTLINE: Tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (SNP) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (E-cadherin) marker transitions. After biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed.
PROJECTED ACCRUAL: A total of 137 samples will be accrued for this study.
研究の種類
入学 (実際)
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
サンプリング方法
調査対象母集団
説明
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer, including any of the following subtypes:
- Adenocarcinoma
- Squamous cell carcinoma
- Bronchoalveolar carcinoma
- Carcinoid
- Stage IIIB or IV or recurrent disease
- Must have received treatment with erlotinib hydrochloride on clinical trial ECOG-E3503
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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
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 |
|---|---|---|
|
Mesenchymal and epithelial markers
時間枠：1 month
|
Mesenchymal and epithelial markers
|
1 month
|
|
Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression)
時間枠：1 month
|
Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers
|
1 month
|
|
Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers
時間枠：1 month
|
Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers
|
1 month
|
|
Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS
時間枠：1 month
|
Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS
|
1 month
|
協力者と研究者
捜査官
- スタディチェア：Jill Kolesar, PharmD、University of Wisconsin, Madison
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
その他の研究ID番号
- CDR0000543981
- ECOG-E3503T1
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。