A Proof of Concept Study of Pan-cancer Early Detection by Liquid Biopsy
NCT ID: NCT04972201
Last Updated: 2024-12-27
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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COMPLETED
2305 participants
OBSERVATIONAL
2021-06-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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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 cancer, from whom blood samples will be collected.
Multi-cancer early detection test
Blood collection and multi-cancer early detection test
Healthy Arm
Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected.
Multi-cancer early detection test
Blood collection and multi-cancer early detection test
Interventions
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Multi-cancer early detection test
Blood collection and multi-cancer early detection test
Eligibility Criteria
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Inclusion Criteria
* 40-75 years old
* Ability to comply with study procedures
* Confirmed diagnosis or suspicious cases of one of the 9 types of cancers within 42 days prior to study blood draw.
* No prior anti-cancer therapy (local or systematic) prior to study blood draw
* Ability to provide a written informed consent
* 40-75 years old
* No cancer-related symptoms or discomfort within 30 days prior to study blood draw
* Ability to comply with study procedures
* No clinically significant finding by laboratory tests and radiology examinations
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
* Known prior diagnosis of malignancies, other current malignant diseases or multiple primary tumors
* No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or diagnosis of a benign disease or precancerous lesions by histopathological assessments, or inability to characterize whether the lesion is malignant or benign
* Pregnancy or lactating women
* 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
* Clinically significant or uncontrolled comorbidities
* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
40 Years
75 Years
ALL
No
Sponsors
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Guangzhou Burning Rock Dx Co., Ltd.
INDUSTRY
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Jie Wang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Other Identifiers
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RSCD2020006
Identifier Type: -
Identifier Source: org_study_id