Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification
Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept
調査の概要
状態
条件
詳細な説明
As part of the study, 35 mL or 2 1/2 tablespoons of blood will be drawn from your arm at each study visit.
This study has 2 visits. Visit 1 will take about 1 hour. Visit 2 is a follow up visit at 6 months taking about 1 hour.
Visit 1- Screening and Blood Collection:
The following procedures will be done at the clinical research facility:
- The study doctor and/or study staff will explain the study and all the study procedures.
- You will be asked to review, sign and date this informed consent before any procedures are done.
- The study doctor and/or study staff will ask you questions about your health status and medical history and record this information.
- 35 mL or 2 ½ tablespoons of blood will be collected from your arm.
- The samples will not be labeled with your name but a unique identification code, which means they will be given a number which can be linked to you.
Visit 2 - Follow up:
If you have been diagnosed with cancer between visit 1 and visit 2, you will not be required to complete visit 2. If you have been diagnosed with LCIS or DCIS, you will be requested to return for visit 2. Otherwise you will return to the center for visit 2.
The following procedures will be performed:
- You will have a follow-up breast evaluation performed. Your follow-up breast evaluation may occur prior to Visit 2 if you have it performed at a different facility or it may be performed during this study visit.
- The study doctor and/or study staff will assess your health and medical history.
- 35 mL or 2 1/2 tablespoons of blood will be collected from your arm.
- The samples will not be labeled with your name but a unique identification code, which means they will be given a number which can be linked to you.
Your blood sample will be sent to the study Sponsor, Provista Diagnostics, Inc. for testing.
The test results will not be reported back to the study doctor and will not be used to determine or change your treatment. This testing will be done in addition to any routine testing that your study doctor performs. You will not receive the results of these tests.
Up to 350 subjects will take part in this study. Patients will be enrolled at one of seven sites.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85006
- Banner Health
-
-
California
-
Sacramento、California、アメリカ、95816
- Sutter Institute
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San Diego、California、アメリカ、92103
- Scripps
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Santa Barbara、California、アメリカ、93102-1200
- Sansum Clinic
-
-
Massachusetts
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Peabody、Massachusetts、アメリカ、01960
- Lahey Clinic
-
-
Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital
-
-
Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Rhode Island Hospital
-
-
South Dakota
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Sioux Falls、South Dakota、アメリカ、57105
- Avera Research Institute
-
-
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
Inclusion Criteria:
- Adult women from 25 years of age to below 50 years of age
- Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
- Study visit and blood collection within 3 weeks (21 days) of ACR BI-RADS assessment
- Patient agrees to return for diagnostic follow-up and blood collection at 6 months unless a positive cancer diagnosis is made between study visits 1 and 2. Individuals diagnosed with LCIS and DCIS will agree to return for visit 2
- Samples collected under IRB approval and Informed Consent
- Testing performed under IRB approval or waiver (as applicable)
Exclusion Criteria:
- Adults from 50 years of age or older and below 25 years of age
- Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
- Subjects that have had a breast biopsy performed at any time prior to the study visit
- Samples not collected under IRB approval and Informed Consent
- Testing not performed under IRB approval or waiver (as applicable)
- Prior breast cancer diagnosis.
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
コホートと介入
グループ/コホート |
|---|
|
Breast Cancer
ACR BI-RAD Category 3 or 4 result
|
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 |
|---|---|---|
|
Training
時間枠：Baseline
|
Part I: Establish an acceptable algorithm for generation of a single numerical score from the combination of the 5 cancer biomarkers that comprise the dtectDX-Breast Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman.
|
Baseline
|
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Blinded Validation
時間枠：6 months
|
Demonstrate proof-of-concept for use of the dtectDx-Breast Assay to assess likelihood of breast cancer malignancy in conjunction with the physicians clinical and radiological evaluations.
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Sensitivity/Specificity
時間枠：Baseline
|
Demonstrate the numerical score, collaborated via proprietary algorithm (greater then 60 is an elevated score, less then 60 is a normal score), for the dtectDx-Breast Assay increases the likelihood of malignant breast cancer detection when used adjunctively with the assessment of BI-RADS Categories 3 and 4 compared to the assessment of BI-RADS Categories 3 and 4 alone.
|
Baseline
|
協力者と研究者
出版物と役立つリンク
便利なリンク
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 (予想される)
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。