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

• Sponsor: Huazhong University of Science and Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04636788
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

This study is for the verification of biomarkers for pancreatic cancer treatment using small RNA liquid biopsy, combined with EUS-FNA tissues.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Adenocarcinoma	Procedure: Venous sampling	N/A

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
• Anticipated Enrollment: 102 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Diagnostic and Prognostic Values of EUS-FNA Specimens and Circulating Exosomal Small RNA in Patients With Pancreatic Cancer
• Actual Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Procedure: Venous sampling; venous sampling of 12ml

Outcome Measures

Primary Outcome Measures

1. senstivity [up to 8 weeks]

   sensitivity of exo-sRNA

2. specificity [up to 8 weeks]

   specificity of exo-sRNA to differentiate between PAAD and other benigh or malignant pancreatic occupying lesions

Secondary Outcome Measures

1. survival time [up to 18 months]

   relationship between expression level of chosen exosomal RNA and patients' survival time in PAAD group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital, Tongji Medical College, HUST	Wuhan	Hubei	China	430030

Sponsors and Collaborators

• Huazhong University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bin Cheng, Professor, Huazhong University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04636788
• Other Study ID Numbers: E-sR2020
• First Posted: Nov 19, 2020
• Last Update Posted: Nov 19, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bin Cheng, Professor, Huazhong University of Science and Technology: exosome; snoRNA; endoscopic ultrasound; liquid biopsy

Study Results

No Results Posted as of Nov 19, 2020