Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay (TM-B1)
調査の概要
詳細な説明
Prospective, two arms, observational, blinded, cohort study enrolling 200 women which intended to validate the cut-off points between women with malignant tumors, benign tumors, and women without tumors (controls) and to validate the sensitivity and specificity of TM-B1 for the detection of an invasive breast tumor.
Two cohorts will be tested with TM-B1. The cohorts will differ in the percentage of women that are expected to yield a positive finding for breast cancer. Any finding in TM-B1 will not influence medical standards of care.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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-
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Rehovot、イスラエル、76100
- 募集
- Kaplan Medical Center
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コンタクト：
- Tanir Alweis, M.D.
- 電話番号：972-50-787-4268
- メール：taniral@clalit.org.il
-
主任研究者：
- Tanir Alweis, MD
-
-
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
Cohort 1: Screening Population - Women presenting for routine XRM and / or breast US.
Cohort 2: Breast Cancer Population - Women who were diagnosed with malignant breast tumors, as determined by biopsy, and have not yet begun any treatment for the disease.
説明
Inclusion Criteria:
Screening Population:
- Subject signed the informed consent.
- Subject is aged 25 years and older.
- Subject is presenting for routine screening or diagnostic XRM and / or breast US.
Breast Cancer Population
- Subject signed the informed consent form.
- Subject is aged 25 years and older.
- Subject was diagnosed with a malignant breast tumor, and has not yet started treatment.
Exclusion Criteria:
All Subjects:
- Subject has been diagnosed with any type of malignancy apart from breast cancer.
- Subject has been previously treated for breast cancer.
- Subject underwent any surgery within the previous year (apart from benign nevus removal).
- Subject was treated for benign tumor within the previous year (e.g. polyps or cysts).
- Subject has an active infection or inflammation from any type of infection (bacterial or viral) as determined clinically at screening.
- Subject is currently taking medications related directly to, or that can affect, the immune system such as steroids.
- Subject has any type of active autoimmune disease such as lupus or rheumatoid arthritis.
- Diagnostic drugs (e.g. contrast materials) were injected or given orally to subject within the last 7 days prior to sample collection for TM-B1 analysis.
- Subject has been taking any investigational drug which influence her health status within 30 days prior to sample collection for TM-B1 analysis.
- Subject is not feeling well at the time of blood collection for TM-B1 analysis due to suspected bacterial or viral infection or subject has symptoms such as high fever, diarrhea, headache, vomiting, dizziness etc.
- Subject is pregnant, lactating, or undergoing fertility treatment.
- Subject has participated in this study, in another cohort, and the TM-B1 test was performed.
Breast Cancer Population only:
- The subject's tumor has been surgically removed before sample collection for TM-B1 analysis.
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：コホート
- 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 |
|---|---|
|
Screening Population
Cohort 1:Screening Population - Women presenting for routine XRM and / or breast US. Participants will be followed for one year and the outcome of those who undergo an annual XRM / breast ultrasound will be recorded. |
Blood samples taken from screening population
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|
Breast Cancer Population
Cohort 2:Breast Cancer Population - Women who were diagnosed with malignant breast tumors, as determined by biopsy, and have not yet begun any treatment for the disease.
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Blood samples taken from Breast Cancer population
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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 |
|---|---|---|
|
This study is intended to evaluate the sensitivity and specificity of the TM-B1 test compared to the Gold Standard diagnostic methods and clinical evaluations based on Digital X-Ray Mammography (XRM), and / or ultrasound, and / or MRI and / or pathology.
時間枠：Timepoint 1, day 1
|
the subject's blood (Groups 1 and 2)will be tested for the presence of breast cancer
|
Timepoint 1, day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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For asymptomatic women who have dense breast tissue (parenchymal density > 50% on XRM), evaluate the performance, in terms of sensitivity and specificity, of the TM-B1 test and XRM together as a breast cancer screening procedure compared to the XRM alone
時間枠：Timepoint one, day 1
|
The subject's blood (Groups 1 and 2) will be tested for the presence of breast cancer
|
Timepoint one, day 1
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Tanir N Alweis, M.D.、Kaplan Medical Center,Pasternak St., POB 1, Rehovot 76100, Israel
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
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 (実際)
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
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