Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detection Platform Through Whole-Genome Sequencing Analysis of Circulating DNA in Cancer and Non-Cancer Subjects
研究概览
详细说明
Written informed consent will be obtained from each participant, and screening will begin after obtaining consent according to the study's inclusion and exclusion criteria.
The informed consent form (ICF) approved by each institution's IRB/EC must be used, and a copy of the signed ICF will be provided to the participant.
For participants who meet the eligibility criteria (meeting all inclusion criteria and none of the exclusion criteria), 20 mL of peripheral whole blood will be collected via standard venipuncture; the time of blood collection will be considered the time of study enrollment.
The collected 20 mL of blood will be divided into two Streck tubes (approximately 10 mL per tube) and must be handled, stored, and submitted according to the most recent laboratory manual.
Cancer participants: Blood will be collected before initiation of any treatment (surgery, chemotherapy, etc.) following cancer diagnosis.
Non-cancer participants: Blood will be collected during routine health examinations.
For domestic (Korean) cases, collected specimens should be stored at room temperature and transported as whole blood (without centrifugation) to the location designated by the sponsor by the following day after collection.
Clinical data of participants (cancer patients and healthy adults)-including sex, age, race, medical history, laboratory tests, imaging, and pathology results-will be collected in the electronic case report form (eCRF).
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Chang Gon Kim
- 电话号码：+82-2-2228-8130
- 邮箱：inspector@yuhs.ac
学习地点
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Seoul、韩国、03722
- 招聘中
- Yonsei Cancer Center
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Adults aged 19 years or older
- Individuals who understand the study and voluntarily provide informed consent.
(only for cancer participants) Participants with newly diagnosed solid tumors (Stage I-IV, including brain tumors) or hematologic malignancies who:
- Have a histologically confirmed diagnosis (including bone marrow biopsy), or
- Are highly suspected of having cancer based on clinical and/or radiologic evaluation and are scheduled for surgical resection after blood collection; and
- Have not yet initiated any treatment (chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, surgical resection, etc.).
- (only for non-cancer participants) Individuals with no prior history of cancer.
- (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.
Exclusion Criteria:
- Pregnancy (self-reported pregnancy status).
- Individuals for whom blood collection is deemed difficult by the investigator.
- Individuals with a history of infection with HIV, HTLV, or syphilis.
- (only for non-cancer participants) Individuals diagnosed with another malignancy within the past 5 years (exceptions: non-melanoma skin cancer, in-situ malignancies, thyroid cancer, and cervical intraepithelial neoplasia treated with curative intent).
- (only for non-cancer participants) Individuals with cancer of unknown primary origin.
- (only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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健康志愿者
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Cancer patients
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test.
大体时间：Assessed up to 36 months
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Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated to evaluate its diagnostic performance for cancer detection.
Sensitivity is defined as the proportion of participants with cancer who test positive on the MCED assay, while specificity is defined as the proportion of participants without cancer who test negative.
Positive predictive value and negative predictive value will be calculated based on the proportion of true-positive and true-negative results among all positive and negative test results, respectively.
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Assessed up to 36 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To evaluate the accuracy of tumor of origin prediction of MCED test.
大体时间：Assessed up to 36 months
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To assess whether tumor of origin predictions from the MCED test are concordant with clinically diagnosed tumor types.
The numbers of concordant and discordant cases will be summarized to evaluate prediction accuracy.
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Assessed up to 36 months
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To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test by stage.
大体时间：Assessed up to 36 months
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Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated according to cancer stage to evaluate stage-specific diagnostic performance.
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Assessed up to 36 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 4-2024-1061
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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