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Pan-canceR Early DetectIon projeCT (PREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04383353
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Guangzhou Burning Rock Dx Co., Ltd.

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. 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.

Condition or disease
Cancer

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Study Type : Observational
Estimated Enrollment : 14026 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : July 21, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : March 2023

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.



Primary Outcome Measures :
  1. The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens. [ Time Frame: 32 months ]
  2. The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model. [ Time Frame: 32 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04383353


Contacts
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Contact: Customer Service Burning Rock 400-689-7600 info@brbiotech.com
Contact: Shangli Cai, Ph.D +86-021 61631938 shangli.cai@brbiotech.com

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences & China National Cancer Center
Beijing, Beijing, China, 100021
Contact: Zhijie Wang, M.D.    +86-010-67781331      
Principal Investigator: Jie Wang, M.D., Ph.D         
China, Shanghai
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai, China, 200011
Contact: Xi Yang, M.D.    +86-021-23271699      
Principal Investigator: Chenping Zhang, M.D.         
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Contact: Qiang Gao, M.D.    +86-021 64041990    ec@zs-hospital.sh.cn   
Principal Investigator: Jia Fan, M.D., Ph.D         
Sponsors and Collaborators
Guangzhou Burning Rock Dx Co., Ltd.
Investigators
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Study Director: Hao Liu, M.D Guangzhou Burning Rock Dx Co., Ltd.
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Responsible Party: Guangzhou Burning Rock Dx Co., Ltd.
ClinicalTrials.gov Identifier: NCT04383353    
Other Study ID Numbers: RSCD2020001
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangzhou Burning Rock Dx Co., Ltd.:
cancer
cell-free DNA (cfDNA) methylation
early detection