Cancer
Conditions
Keywords
Cancer, liquid biopsy, cell-free DNA (cfDNA) methylation, circulating tumor DNA (ctDNA) mutation, whole blood miRNA
Brief summary
ASCEND-PANCREATIC is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, circulating tumor DNA (ctDNA) mutation, serum protein markers and blood miRNA markers, in which of 7,062 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 healthy individuals. The performance of the pancreatic cancer detection test will be evaluated in participants with high risk of pancreatic cancer.
Interventions
None listed
Sponsors
Guangzhou Burning Rock Dx Co., Ltd.
Ruijin 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: * Age 40-75 years old. * Able to provide a written informed consent. * No prior cancer treatment (local or systematic) with either of the following: A. Pathologically confirmed cancer diagnosis within 42 days prior to blood draw. B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.
Exclusion criteria
for Cancer Arm Participants: * Insufficient qualified blood samples. * During pregnancy or lactation. * Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. * Recipient of blood transfusion within 7 days prior to blood draw. * Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw. * With other known malignant tumors or multiple primary tumors. Inclusion Criteria for Benign Disease Arm Participants: * Age 40-75 years old. * 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 |
|---|---|
| Sensitivity and specificity of the cfDNA methylation-based model in detecting pancreatic cancer. | 30 months |
| The performance of the cfDNA methylation-based model in pancreatic cancer early detection in participants at high risk for pancreatic cancer. | 90 months |
Secondary
| Measure | Time frame |
|---|---|
| The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages. | 30 months |
| Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers. | 30 months |
| Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting pancreatic cancer, respectively. | 30 months |
Other
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of a blood miRNA-based model in detecting pancreatic cancer. | 30 months |
Countries
China
Contacts
Primary ContactQian Zhan, M.D.
Backup ContactYuzi Zhang, M.D.
Outcome results
None listed