Cancer
Conditions
Keywords
pancreatic cancer, liquid biopsy, cell-free DNA (cfDNA) methylation, whole blood miRNA, others
Brief summary
DAYBREAK is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, serum protein markers, blood miRNA markers and others, in which of 450 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers and benign disease through a two-stage approach. The sensitivity and specificity of the model in pancreatic cancer early detection will be evaluated.
Interventions
None listed
Sponsors
Guangzhou Burning Rock Bioengineering Ltd.
Changhai Hospital
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 42 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 42 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 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 42 days after study blood draw.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of multi-cancer early detection by the combined model in cancer arm and benign disease arm | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages. | 12 months |
| Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers. | 12 months |
| Sensitivity and specificity for detecting pancreatic cancer of a the protein panel-based model, in combination with other biomarkers. | 12 months |
| Sensitivity and specificity of the blood miRNA-based model in detecting pancreatic cancer. | 12 months |
Countries
China
Contacts
Primary ContactShiwei Guo, M.D.
Backup ContactYuzi Zhang, M.D.
Outcome results
None listed