Research on the Value of Genomics Research Based on Ultrasound Endoscopic Biopsy in the Differential Diagnosis and Prognostic Evaluation of Pancreatic Occupancy

July 29, 2021 updated by: Xiangyu Kong, Changhai Hospital
To clarify the value of genomic testing in the clinical diagnosis or prognosis of pancreatic space occupation, provide a basis for the selection of clinical diagnosis methods for pancreatic space occupation, optimize clinical management strategies, and improve the prognosis of patients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

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
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Occupying lesions of the pancreas, specifically including benign diseases and malignant diseases, mainly pancreatic cancer has a very high incidence. Elderly patients, especially those who drink alcohol all year round, have a lot of occurrences, and many patients are already in the middle or advanced stage when they are diagnosed.

Description

Inclusion Criteria:

  1. Age 18-85, no gender limit
  2. Imaging examinations suggest that the clear pancreas has clear space-occupying lesions
  3. Admitted to our department, ready to undergo endoscopic ultrasound biopsy to confirm the diagnosis

Exclusion Criteria:

  1. There are contraindications for endoscopic ultrasound biopsy
  2. Failed to join the group or refused follow-up due to various reasons

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

Cohorts and Interventions

Group / Cohort
Benign pancreatic space occupying group
Malignant pancreatic space occupying group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differential microRNA detected by sequencing
Time Frame: June 2023
The diagnosis of microRNA in pancreatic space occupying
June 2023
Differential mRNA detected by sequencing
Time Frame: June 2023
The diagnosis of mRNA in pancreatic space occupying
June 2023
Differential lncRNA detected by sequencing
Time Frame: June 2023
The diagnosis of lncRNA in pancreatic space occupying
June 2023

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

October 1, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-PC-Maker(V1.1）

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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