Circulating Extracellular Exosomal Small RNA as Potential Biomarker for Human Pancreatic Cancer

Not Applicable

• Conditions: Pancreas Adenocarcinoma
• Interventions: Procedure: Venous sampling

• Registration Number: NCT04636788
• Lead Sponsor: Huazhong University of Science and Technology

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 Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-01
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-14
• Last Update Submitted: 2020-11-14
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• age >18
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pancreatic cancer group	Venous sampling	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

Primary Outcome Measures

Name	Time	Method
senstivity	up to 8 weeks	sensitivity of exo-sRNA
specificity	up to 8 weeks	specificity of exo-sRNA to differentiate between PAAD and other benigh or malignant pancreatic occupying lesions

Secondary Outcome Measures

Name	Time	Method
survival time	up to 18 months	relationship between expression level of chosen exosomal RNA and patients' survival time in PAAD group

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, HUST; 🇨🇳 Wuhan, Hubei, China