Blinded Assessment of CancerSpot’s Screening Accuracy in Clinical Cohorts
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Validation of CancerSpotTM will aid in early detection of cancer, and aid in future population
研究概览
简要总结
CancerSpotTM is a non-invasive, blood-based test designed for the early-stage screening of different types of cancer with the ability to predict the top two possible cancer types for 10 different cancers - breast, cervix, colorectal, esophagus, lung, stomach, liver, gallbladder, pancreas, and ovary in treatment-naïve individuals. This test allows the detection of multiple cancer types simultaneously, enhancing the early identification of cancer and improving patient outcomes through earlier intervention. This study is validating CancerSpotTM, a launched blood test designed to detect early-stage cancers by analyzing cancer-specific changes in DNA found in the blood. It is a blinded study, and once the blinding is broken, the results will be used to assess how accurately CancerSpotTM detects cancer (sensitivity) and correctly identifies those without cancer (specificity). Validation of CancerSpotTM will aid in early detection of cancer, and aid in future population screening for early detection of cancer, specially through health check programs.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with pathologically confirmed malignancy of breast, cervix, colorectal, esophagus, lung, stomach, liver, gallbladder, pancreas and ovary, as identified by the site Principal Investigator or Co-Investigators.
- •Patients diagnosed with clinical staging I, II and III only
- •Patients who are treatment-naïve (no prior chemotherapy or oncosurgery or oncotherapy or any oncology investigational agent(s))
- •Willingness to be recontacted by the PI for gathering future clinical status
- •Willingness to provide informed consent Cohort 2
- •Healthy volunteers with no known symptoms suggestive of cancer including benign, precancerous lesions as identified by the site Principal Investigator or Co-Investigators through routine clinical care processes.
- •Willingness to provide informed consent.
排除标准
- •Cohorts 1 and 2
- •Subjects below 18 years
- •Subjects who have an active or chronic infection
- •Women who are pregnant or suspect they are pregnant and lactating mothers
- •Cases with prior diagnostic complications or unconventional pathology or rare/unclassified tumor subtypes
- •Subjects with prior history of malignancy (other than the current primary for Cohort 1)
- •Subjects with benign, borderline, or precancerous conditions
- •Subjects with significant comorbidities that, in the opinion of the investigator, may confound study results (e.g., autoimmune disorders, recent major surgery, organ failure, etc.).
结局指标
主要结局
Validation of CancerSpotTM will aid in early detection of cancer, and aid in future population
时间窗: Preliminary assessment at 10 percent of recruitment | Final assessment at the end of recruitment
screening for early detection of cancer.
时间窗: Preliminary assessment at 10 percent of recruitment | Final assessment at the end of recruitment
次要结局
未报告次要终点
研究者
Dr Vamsi Veeramachaneni
Strand Life Sciences Private Limited