Status:
UNKNOWN
Pan-canceR Early DetectIon projeCT
Lead Sponsor:
Guangzhou Burning Rock Dx Co., Ltd.
Conditions:
Cancer
Eligibility:
All Genders
40-75 years
Brief Summary
PREDICT is a prospective, multi-center study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation based model, in which approximately 14,000 participants will be enrolled. T...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Cancer Arm Participants:
- Able to provide a written informed consent.
- Able to provide sufficient and qualified blood samples for study tests.
- No prior or undergoing cancer treatment (local or systematic) with either of the following:
- A. Pathologically confirmed cancer diagnosis within 30 (±7) days prior to the study blood draw.
- B. High suspicious for cancer diagnosis by radiological or other routine clinical assessments, with confirmed cancer diagnosis through biopsy or surgical resection within 36 (±7) days after study blood draw.
- Exclusion Criteria for Cancer Arm Participants:
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 30 days prior to study blood draw.
- With other known malignant tumors or multiple primary tumors.
- Inclusion Criteria for Benign Disease Arm Participants:
- Able to provide a written informed consent.
- Able to provide sufficient and qualified blood samples for study tests.
- Have either of the following:
- A. Pathological confirmed diagnosis of benign diseases within 90 (±7) days prior to the study blood draw, with no prior treatment such as surgical resection.
- B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 36 (±7) days after study blood draw.
- Exclusion Criteria for Benign Disease Arm Participants:
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 30 days prior to study blood draw.
- Inclusion Criteria for Non-Tumor Arm Participants:
- Able to provide a written informed consent.
- Able to provide sufficient and qualified blood samples for study tests.
- No cancer related symptoms within 30 days prior to study screening.
- Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.
- Exclusion Criteria for Non-Tumor Arm Participants:
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 30 days prior to study blood draw.
- Recipient of anti-infectious therapy within 14 days prior to study blood draw.
- Have received or are undergoing curative cancer treatment within three years prior to study screening.
- With autoimmune or other diseases with severe comorbidities.
Exclusion
Key Trial Info
Start Date :
July 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
14026 Patients enrolled
Trial Details
Trial ID
NCT04383353
Start Date
July 21 2020
End Date
March 1 2023
Last Update
July 22 2020
Active Locations (3)
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1
Cancer Hospital, Chinese Academy of Medical Sciences & China National Cancer Center
Beijing, Beijing Municipality, China, 100021
2
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
3
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032