Status:
UNKNOWN
Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Guangzhou Burning Rock Dx Co., Ltd.
Conditions:
Cancer
Eligibility:
All Genders
40-75 years
Brief Summary
PRESCIENT is a multi-center, prospective observational study aimed to detect cancers early by combined assays for serum protein markers and cell-free DNA (cfDNA) methylation markers. Blood RNA markers...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All the Participants:
- Ability to provide a written informed consent
- 40-75 years old
- Exclusion Criteria for All the Participants:
- Inability to comply with study procedures
- 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 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
- Exclusion Criteria for Cancer Arm Participants:
- 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
- Inclusion Criteria for Benign Diseases Arm Participants:
- 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
- Exclusion Criteria for Benign Diseases Arm Participants:
- 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
- Inclusion Criteria for Non-tumor (Healthy) Arm Participants:
- 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 for Non-tumor (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 :
March 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
11879 Patients enrolled
Trial Details
Trial ID
NCT04822792
Start Date
March 23 2021
End Date
June 30 2023
Last Update
June 2 2021
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021