Status:
COMPLETED
The Unintrusive Detection of EaRly-stage Cancers
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Guangzhou Burning Rock Dx Co., Ltd.
Conditions:
Cancer
Eligibility:
All Genders
40-75 years
Brief Summary
According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-cen...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All the Participants:
- Ability to provide a written informed consent
- 40-75 years old
- Ability to comply with study procedures
- Exclusion Criteria for All the Participants:
- 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
- Inclusion Criteria for Cancer Arm Participants:
- Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw.
- No prior anti-cancer therapy (local or systematic) prior to study blood draw
- Exclusion Criteria for Cancer Arm Participants:
- Known prior or current diagnosis of other types of malignancies or multiple primary tumors
- Diagnosis of benign diseases by histopathological assessments
- No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign
- Non-small-cell lung cancer patients with ground-class nodularity by radiological examination
- Diagnosis of precancerous lesions
- Inclusion Criteria for Healthy Arm Participants:
- No cancer-related symptoms or discomfort within 30 days prior to study blood draw
- No clinically significant finding by physical examinations, hematological assessment, urinalysis, 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 for Healthy Arm Participants:
- Prior or ongoing treatment of cancer within 3 years prior to study blood draw
- Clinically significant or uncontrolled comorbidities
Exclusion
Key Trial Info
Start Date :
April 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
2508 Patients enrolled
Trial Details
Trial ID
NCT04820868
Start Date
April 23 2021
End Date
April 30 2022
Last Update
March 16 2023
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032