Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT
NCT ID: NCT04822792
Last Updated: 2021-06-02
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
11879 participants
OBSERVATIONAL
2021-03-23
2023-06-30
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 cancer, from whom blood samples will be collected
Multi-cancer early detection test
Blood collection and multi-cancer early detection test
Benign Diseases Arm
Participants with benign diseases corresponding to the tumor types in the Cancer Arm, 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 disease, 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
* Confirmed diagnosis or suspicious cases of one of the 22 types of malignancies within 42 days prior to study blood draw
* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
* Confirmed diagnosis of benign diseases corresponding to the tumor types in the Cancer Arm by histopathological or radiological assessments within 90 days prior to study blood draw
* No prior treatment of benign diseases prior to study blood draw
* No cancer-related symptoms or discomfort within 30 days prior to study blood draw
* No clinically significant finding by LDCT or ultrasound
* No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants
* No active hepatitis B or hepatitis C infection
Exclusion Criteria
* 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
* 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 by histopathological assessments, or inability to characterize whether the lesion is malignant or benign
* Non-small-cell lung cancer patients with ground-class nodularity by radiological examination
* History of malignancies
* Current malignancies or precancerous lesions
* No confirmed diagnosis of a benign disease by radiological, endoscopic or histopathological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign
* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
* Clinically significant or uncontrolled comorbidities
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 Hospital Chinese Academy of Medical Sciences
Beijing, Beijing 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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RSCD2020002
Identifier Type: -
Identifier Source: org_study_id
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