NCT04927130Unknown不适用
An International Multicenter Blind Retrospective Comparative in Vitro Case-controlled Study of the ARNA Breast Liquid Biopsy Test System in Women With Biopsy Confirmed Breast Cancer
ARNA Genomics US Inc.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The number of true positive cases
研究概览
简要总结
Proof of Concept retrospective study. Women who have the diagnosis Breast Cancer ( confirmed by biopsy) will donate a blood samples. Tubes with blood will be transferred to the Sponsors Laboratory and ARNA Breast Test will be performed. The result of test will be compared with the biopsy result for each person.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Availability of signed and dated informed consent.
- •Women from 35 to 65 years old, who are generally healthy, with confirmed breast cancer. Or without any neoplasms in breast (control group)
- •Presence of a documented biopsy
- •Presence of mammography, ultrasound or MRI of the mammary glands no later than three months.
排除标准
- •Pregnancy.
- •Any other cancers diagnosed now or previously, with the exception of breast cancer.
- •Therapy with cytostatic during the last three months.
- •Chemotherapy within the past three months.
- •Therapy with hormonal drugs, including all forms of contraceptive drugs.
- •Therapy with other prohibited groups of drugs.
- •Systolic blood pressure > 180 mm Hg. and / or diastolic blood pressure > 120 mm Hg. with repeated measurements.
- •Simultaneous participation in another clinical study.
- •Relative affiliation to the clinic, for example, the patient is a close relative of the researcher or a dependent person (for example, a clinic employee or student or a sponsor employee).
- •A clinically significant condition or laboratory result that, in the opinion of the investigator, threatens the safety of the test subject, may interfere with assessments, or prevent the completion of the study.
- •Failure to cooperate to participate in planned procedures, including the following examples: lack of understanding of language, mental illness, inability to visit the clinic.
- •Diseases or conditions that may affect the conduct of the study or the interpretation of the results.
- •History of organ transplantation.
- •Blood transfusions within the last 6 months.
结局指标
主要结局
The number of true positive cases
时间窗: through study completion, an average of 1 year
the absolute total number of matches between the results of the test system and histological confirmation of the diagnosis.
次要结局
未报告次要终点
研究者
研究点 (1)
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