PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVEII
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer arm Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected |
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| Healthy arm Participants without a known cancer or certain benign disease, from whom blood samples will be collected |
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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 [24months]
Eligibility Criteria
Criteria
Inclusion Criteria for Cancer Arm Participants:
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Age 18 years or older
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Able to provide a written informed consent
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Confirmed diagnosis or highly suspicious cases of gynecologic malignancies within 42 days prior to blood collection
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No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
Exclusion Criteria for Cancer Arm Participants:
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Pregnancy or lactating women
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Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
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Recipients of blood transfusion within 7 days prior to study blood draw
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Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer.
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previous history of malignant tumor;
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precancerous lesions or benign diseases confirmed by biopsy or surgical specimen;
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unknown or insufficient to determine the nature of the lesion by histopathological reports;
Inclusion Criteria for healthy control Arm Participants:
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Able to provide a written informed consent.
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Able to provide sufficient and qualified blood samples for study tests.
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No cancer related symptoms within 30 days prior to study screening.
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Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.
Exclusion Criteria for healthy control Arm Participants:
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Insufficient qualified blood sample for study test.
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During pregnancy or lactation.
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Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
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Recipient of blood transfusion within 30 days prior to study blood draw.
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Recipient of anti-infectious therapy within 14 days prior to study blood draw.
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Have received or are undergoing curative cancer treatment within three years prior to study screening.
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With autoimmune or other diseases with severe comorbidities.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan university shanghai cancer center, Deparment of gynecologic oncology | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
- Guangzhou Burning Rock Dx Co., Ltd.
Investigators
- Principal Investigator: Xiaohua Wu, MD.&PHD, Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RSCD2021002