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| Name | Class |
|---|---|
| Guangzhou Burning Rock Dx Co., Ltd. | INDUSTRY |
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This study is a prospective study aimed to validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 2935 female participants, including participants with gynecologic cancers patients and healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer arm | Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected | ||
| Healthy arm | Participants without a known cancer or certain benign disease, from whom blood samples will be collected |
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| Measure | Description | Time Frame |
|---|---|---|
| To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies. | 24months | |
| To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors |
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Inclusion Criteria for Cancer Arm Participants:
Exclusion Criteria for Cancer Arm Participants:
Inclusion Criteria for healthy control Arm Participants:
Exclusion Criteria for healthy control Arm Participants:
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Eligible participants will be recruited from the participating medical center and assigned into two arms, including participants with new diagnosis of gynecologic malignancies and healthy controls
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Wen, MD.&PHD | Contact | +86-021-64175590 | 81007 | wenhao_fdc@163.com |
| Yuzi Zhang, MD | Contact | +86-021-60293798 | Z_Zhangyuzi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohua Wu, MD.&PHD | Department of Gynecological Oncology, Fudan University Shanghai Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan university shanghai cancer center, Deparment of gynecologic oncology | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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Plasma, white blood cells
| 24months |