- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04383353
Pan-canceR Early DetectIon projeCT (PREDICT)
July 20, 2020 updated by: Guangzhou Burning Rock Dx Co., Ltd.
Burning Rock Pan-canceR Early DetectIon projeCT (PREDICT): a Prospective, Multicenter Study to Develop and Validate the Performance of a cfDNA Methylation Based Model on Early Cancer Detection
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.
The development and validation of the model will be conducted in participants with early stage cancers or benign diseases, along with non-tumor (healthy) individuals through a two-stage approach.
The sensitivity and specificity of the model in cancer early detection will be evaluated, and the accuracy of the identification for tissue of origin will be obtained.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
14026
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Customer Service Burning Rock
- Phone Number: 400-689-7600
- Email: info@brbiotech.com
Study Contact Backup
- Name: Shangli Cai, Ph.D
- Phone Number: +86-021 61631938
- Email: shangli.cai@brbiotech.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Cancer Hospital, Chinese Academy of Medical Sciences & China National Cancer Center
-
Contact:
- Zhijie Wang, M.D.
- Phone Number: +86-010-67781331
-
Principal Investigator:
- Jie Wang, M.D., Ph.D
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Zhongshan Hospital, Fudan University
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Principal Investigator:
- Jia Fan, M.D., Ph.D
-
Contact:
- Qiang Gao, M.D.
- Phone Number: +86-021 64041990
- Email: ec@zs-hospital.sh.cn
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Shanghai, Shanghai, China, 200011
- Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
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Contact:
- Xi Yang, M.D.
- Phone Number: +86-021-23271699
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Principal Investigator:
- Chenping Zhang, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Eligible participants will be recruited from medical centers and assigned into three arms, including participants with new diagnosis of malignancy or corresponding benign disease, and participants without the presence of malignant or benign diseases.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Cancer arm
Participants with new diagnosis of cancer, from whom a blood sample and contemporaneous tissue samples will be collected.
|
Benign disease arm
Participants with benign diseases corresponding to the tumor types in the cancer arm, from whom a blood sample and contemporaneous tissue samples will be collected.
|
Non-tumor arm (Healthy)
Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens.
Time Frame: 32 months
|
32 months
|
The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model.
Time Frame: 32 months
|
32 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in pre-specified subgroups.
Time Frame: 32 months
|
32 months
|
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in combination with clinicopathological characteristics or other biomarkers.
Time Frame: 32 months
|
32 months
|
The examinations related to cancer diagnosis from the participants who were identified as positive cases by cfDNA methylation based model while as healthy individuals by routine medical examinations.
Time Frame: 32 months
|
32 months
|
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in the independent training and validation sets.
Time Frame: 32 months
|
32 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hao Liu, M.D, Guangzhou Burning Rock Dx Co., Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 21, 2020
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
May 7, 2020
First Submitted That Met QC Criteria
May 7, 2020
First Posted (Actual)
May 12, 2020
Study Record Updates
Last Update Posted (Actual)
July 22, 2020
Last Update Submitted That Met QC Criteria
July 20, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- RSCD2020001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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