Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease
Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up
RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.
PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast disease.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
Primary
- To establish a specimen bank from peripheral blood specimens collected from women with a full spectrum of breast disease (invasive breast cancer [IBC], ductal or lobular carcinoma in situ [CIS], or benign breast disease [BBD]) with standardized clinical follow up and serial specimen collection for those with IBC.
- To determine the ability of quantitative real-time reverse-transcriptase PCR (qRT-PCR) to discriminate between patients with IBC, CIS, and BBD by comparing baseline assay values from pre-biopsy specimens to the histologic diagnosis.
- To determine the ability of qRT-PCR to predict treatment response by comparing serial assay values from patients with evaluable IBC to their objective response.
- To determine the ability of qRT-PCR to predict relapse by comparing the serial assay values from all patients with IBC to their disease status.
- To determine the ability of qRT-PCR to perform as an independent prognostic factor by comparing baseline assay values from all patients with IBC to their disease status, stratified by known breast cancer prognostic factors.
Secondary
- To perform exploratory studies identifying potential targets for novel nucleic acid and proteomic-based early detection assays.
OUTLINE: Patients undergo baseline peripheral blood specimen collection pre-biopsy and then periodically for up to 10 years. Specimens are analyzed for circulating tumor cells via quantitative real-time reverse-transcriptase PCR, immunofluorescence, and bidirectional pyrophosphorolysis-activated polymerization allele-specific amplification; and for protein profiles via mass spectometry, liquid chromatography, enzyme digestion, and tandem mass spectometry. Patients' tumor tissue (invasive breast cancer [IBC] only) is analyzed for p53 via IHC. Medical records are reviewed periodically.
Patients with IBC complete a quality of life assessment at baseline and every 6 months for up to 10 years.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
California
-
Beverly Hills、California、アメリカ、90211
- Tower Cancer Research Foundation
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Duarte、California、アメリカ、91010-3000
- City of Hope Comprehensive Cancer Center
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Pasadena、California、アメリカ、91105
- City of Hope Medical Group
-
-
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:
Biopsy-confirmed diagnosis of one of the following:
Stage I-IV infiltrating ductal or infiltrating lobular carcinoma
- Patients with early-stage disease must not have started systemic treatment; if no systemic treatment is planned, patients must be either preoperative or ≤ 120 days since definitive breast surgery
- Patients with locally advanced disease must be scheduled for neoadjuvant chemotherapy prior to initiation of systemic treatment
- Ductal carcinoma in situ
- Lobular carcinoma in situ
Benign breast disease
- Proliferative or non-proliferative
- With or without atypia
PATIENT CHARACTERISTICS:
- Karnofsky performance status 50-100%
- Not pregnant
- No prior invasive cancer diagnosis within the past 5 years except for squamous cell or basal cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic therapy (chemotherapy or hormonal therapy) for patients with stage I-III disease
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
- 観測モデル：ケースコントロール
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Normal benign breast disease or ductal carcinoma in situ
|
|
|
Invasive breast cancer
|
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 |
時間枠 |
|---|---|
|
Establishment of a specimen bank
時間枠：5 Years of specimen collection
|
5 Years of specimen collection
|
|
Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results
時間枠：5 years
|
5 years
|
|
Ability of the qRT-PCR to predict treatment response
時間枠：5 years
|
5 years
|
|
Ability of the qRT-PCR to predict relapse
時間枠：5 years
|
5 years
|
|
Ability of the qRT-PCR to perform as an independent prognostic factor
時間枠：5 years
|
5 years
|
協力者と研究者
捜査官
- 主任研究者：Robert Hickey, Ph.D.、City of Hope Comprehensive Cancer Center
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 (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
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。
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