Cancer
Conditions
Keywords
cancer, cell-free DNA (cfDNA) methylation, early detection
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.
Interventions
None listed
Sponsors
Guangzhou Burning Rock Dx Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens. | 32 months |
| The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model. | 32 months |
Secondary
| 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. | 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. | 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. | 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. | 32 months |
Countries
China
Contacts
Primary ContactCustomer Service Burning Rock
Backup ContactShangli Cai, Ph.D
Outcome results
None listed