NCT06776835

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Dec 2023Nov 2026

Study Start

First participant enrolled

December 10, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

2.8 years

First QC Date

January 10, 2025

Last Update Submit

January 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analysis of relative quantitative of small non-coding RNAs

    Relative quantitative of small non-coding RNAs are detected by quantitative RT-PCR

    an average of 2 years

Study Arms (2)

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

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

Interventions

Each participant was enrolled to assess the of relative quantitative of small non-coding RNAs

Controls from medical centers in ChinaGastric cancer cases from medical centers in China

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

AFFILIATED HOSPITAL OF NANTONG UNIVERSITY

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 15, 2025

Study Start

December 10, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations