Diagnostic and Prognostic Values of EUS-FNA Specimens and Circulating Exosomal Small RNA in Patients With Pancreatic Cancer
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- senstivity
Study Overview
Brief Summary
This study is for the verification of biomarkers for pancreatic cancer treatment using small RNA liquid biopsy, combined with EUS-FNA tissues.
Detailed Description
CA19-9 is the FDA approved biomarker for the diagnosis of pancreatic cancer. However, the specificity of CA19-9 to differentiate between pancreatic cancer, cholangiocarcinoma, or other pancreatic lesions is not satisfying enough.
Tumor cells secret abundant exosomes in the early stage. Circulating tumor cells are detected mainly in the advanced stage. Meanwhile, the role of non-coding RNA draws more and more attention in tumor area. Exosomes protect inside RNA from plasma RNase. Compared with long RNA, small RNA, including miRNA, snoRNA, tRNA, piRNA could exist more stably.
By means of next-generation sequencing, we look forward to finding new exosomal small RNA biomarkers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •pancreatic cancer patients
- •pancreatic lesions other than PAAD
- •chronic pancreatitis
- •cholangiocarcinoma
Exclusion Criteria
- •diagnosed with other pathological types of cancer
- •treated with chemo/radio/surgery previously
Arms & Interventions
pancreatic cancer group
pancreatic cancer, anticipated participants: 68
other pancreatic lesions including MCN, SCN, IPMN, SPN without malignant pathological finding chronic pancreatitis cholangiocarcinoma healthy control anticipated participants: 34
Intervention: Venous sampling (Procedure)
Outcomes
Primary Outcomes
senstivity
Time Frame: up to 8 weeks
sensitivity of exo-sRNA
specificity
Time Frame: up to 8 weeks
specificity of exo-sRNA to differentiate between PAAD and other benigh or malignant pancreatic occupying lesions
Secondary Outcomes
- survival time(up to 18 months)
Investigators
Bin Cheng
Professor
Huazhong University of Science and Technology