PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-II
NCT ID: NCT06001099
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2935 participants
OBSERVATIONAL
2023-02-22
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cancer arm
Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected
No interventions assigned to this group
Healthy arm
Participants without a known cancer or certain benign disease, from whom blood samples will be collected
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able to provide a written informed consent
* Confirmed diagnosis or highly suspicious cases of gynecologic malignancies within 42 days prior to blood collection
* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* No cancer related symptoms within 30 days prior to study screening.
* Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.
Exclusion Criteria
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer.
* previous history of malignant tumor;
* precancerous lesions or benign diseases confirmed by biopsy or surgical specimen;
* unknown or insufficient to determine the nature of the lesion by histopathological reports;
* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 30 days prior to study blood draw.
* Recipient of anti-infectious therapy within 14 days prior to study blood draw.
* Have received or are undergoing curative cancer treatment within three years prior to study screening.
* With autoimmune or other diseases with severe comorbidities.
18 Years
FEMALE
Yes
Sponsors
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Guangzhou Burning Rock Dx Co., Ltd.
INDUSTRY
Fudan University
OTHER
Responsible Party
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Zhong Zheng MD
Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
Principal Investigators
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Xiaohua Wu, MD.&PHD
Role: PRINCIPAL_INVESTIGATOR
Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
Locations
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Fudan university shanghai cancer center, Deparment of gynecologic oncology
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RSCD2021002
Identifier Type: -
Identifier Source: org_study_id
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