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
14026 participants
OBSERVATIONAL
2021-03-29
2023-03-31
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 testing
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 testing
Non-tumor (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 testing
Interventions
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Multi-cancer early detection test
Blood collection and multi-cancer early detection testing
Eligibility Criteria
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Inclusion Criteria
* 40-75 years old
* Confirmed diagnosis of a cancer or highly suspicious cases of cancer within 42 days prior to study blood draw. Tumor types in this study include lung cancer, colorectal cancer, liver cancer, ovarian cancer, gastric cancer, esophageal cancer, pancreatic cancer, biliary tract cancer, squamous cell carcinoma of the head and neck (except nasopharyngeal carcinoma)
* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
* Histopathologically confirmed or highly suspicious for benign diseases corresponding to the tumor types in the Cancer Arm within 90 days prior to study blood draw, or highly suspicious for benign diseases corresponding to the tumor types in Cancer Arm by radiological assessments or other clinical examinations
* No prior treatment of benign disease 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 abdominal ultrasound
* No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or cervical liquid-based cell (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
* Current or history of malignancies or precancerous lesions
* No confirmed diagnosis or inability to characterize a benign disease by radiological, endoscopic or histopathological assessments within 42 days of study blood draw
* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
* Unexplained weight loss
* Prior or current major diseases, including COPD, interstitial pneumonia, viral hepatitis, liver cirrhosis, inflammatory bowel disease
* Prior and current adenoma of the intestine and polyp of the intestine
* Changes in bowel habits, bowel abnormalities, hematochezia within 30 days prior to study blood draw
* Uncontrolled hypertension and other cardiovascular diseases
* Currently severe bleeding disorders
* Major surgery within 24 weeks prior to study blood draw
* Infection requiring anti-microbial therapy within 24 weeks prior to study blood draw
* Current autoimmunity disease
* Clinically significant or uncontrolled comorbidities which, in the investigator's opinion, should be excluded
40 Years
75 Years
ALL
Yes
Sponsors
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Guangzhou Burning Rock Dx Co., Ltd.
INDUSTRY
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Jia Fan, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences & China National Cancer Center
Beijing, Beijing Municipality, China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University, School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhijie Wang, M.D.
Role: primary
Xi Yang, M.D.
Role: primary
Qiang Gao, M.D.
Role: primary
Other Identifiers
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RSCD2020001
Identifier Type: -
Identifier Source: org_study_id