Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker for Gastric Cancer

January 10, 2025 updated by: Affiliated Hospital of Nantong University

Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker for Gastric Cancer and Exploring Its Correlation With Prognostic Diagnosis

Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early. Small non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as an auxiliary diagnostic biomarker for gastric cancer.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early.

Small non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated by previous scientific researches that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as a new biomarker panel for gastric cancer.

The purpose of the present clinical trail is to explore the correlation between small non-coding RNAs panel and early gastric cancer, and to elucidate the possibility of small non-coding RNAs panel as a biomarker for gastric cancer. Verify the experimental purpose by monitoring the relative quantification of small non-coding RNAs panel through high-throughput sequencing and qRT PCR technology.

Study Type

Observational

Enrollment (Estimated)

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 Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226001
        • Affiliated Hospital of Nantong University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

AFFILIATED HOSPITAL OF NANTONG UNIVERSITY

Description

Inclusion Criteria:

  • Having signed informed consent
  • Age≥ 18 years old and ≤ 85 years old
  • Histologically confirmed gastric cancer

Exclusion Criteria:

  • Other previous malignancy within 5 year
  • Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
  • Pregnancy or lactation period
  • Legal incapacity

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
Intervention / Treatment
Gastric cancer cases from medical centers in China
Measurement of levels of circulating small non-coding RNAs
Diagnostic test: Analysis of relative quantitative of small non-coding RNAs
Each participant was enrolled to assess the of relative quantitative of small non-coding RNAs
Controls from medical centers in China
Measurement of levels of circulating small non-coding RNAs
Diagnostic test: Analysis of relative quantitative of small non-coding RNAs
Each participant was enrolled to assess the of relative quantitative of small non-coding RNAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of relative quantitative of small non-coding RNAs
Time Frame: an average of 2 years
Relative quantitative of small non-coding RNAs are detected by quantitative RT-PCR
an average of 2 years

Collaborators and Investigators

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

Sponsor

Affiliated Hospital of Nantong University

Collaborators

Jiangsu Cancer Institute & Hospital
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

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)

December 10, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-L166

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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