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

November 14, 2020 updated by: Bin Cheng, Huazhong University of Science and Technology

Diagnostic and Prognostic Values of EUS-FNA Specimens and Circulating Exosomal Small RNA in Patients With Pancreatic Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College, HUST
        • Contact:
        • Sub-Investigator:
          • Yuchong Zhao, M.D.
        • Principal Investigator:
          • Bin Cheng, M.D./Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
senstivity
Time Frame: up to 8 weeks
sensitivity of exo-sRNA
up to 8 weeks
specificity
Time Frame: up to 8 weeks
specificity of exo-sRNA to differentiate between PAAD and other benigh or malignant pancreatic occupying lesions
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival time
Time Frame: up to 18 months
relationship between expression level of chosen exosomal RNA and patients' survival time in PAAD group
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 14, 2020

First Posted (ACTUAL)

November 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 14, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-sR2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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