Cancer
Conditions
Keywords
Cancer, liquid biopsy, cell-free DNA (cfDNA) methylation, circulating tumor DNA (ctDNA) mutation, whole blood miRNA
Brief summary
ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.
Interventions
DIAGNOSTIC_TESTBlood draw and blood-based biomarkers analyses
blood-based biomarkers analyses
Sponsors
Guangzhou Burning Rock Bioengineering Ltd.
Shanghai Zhongshan Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
for Cancer Arm Participants: * Age 40-75 years at the day of consenting to the study. * 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 at the day of consenting to the study. * 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 gastric cancer. | 30 months |
Secondary
| Measure | Time frame |
|---|---|
| The differences of sensitivity and specificity in gastric cancer participants at different clinical stages. | 30 months |
| Sensitivity and specificity for detecting gastric 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 gastric cancer, respectively. | 30 months |
Other
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of a blood miRNA-based model in detecting gastric cancer. | 30 months |
Countries
China
Contacts
Primary ContactYihong Sun, MD
Backup ContactXuefei Wang, MD
Outcome results
None listed