Use of Circulating Exosomal LncRNA-GC1 to Monitor Gastric Cancer

NCT ID: NCT05397548

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-12-31

Brief Summary

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Background:

Although its incidence and mortality has decreased, gastric cancer (GC) is the fourth most common cancer and the second leading cause of cancer-related death worldwide, particularly in China. The number of new cases and deaths may comprise approximately one-half of the global total. The high mortality of GC is partially attributed to late detection and nonspecific symptoms. The current gold standard for diagnosing GC is endoscopic biopsy. However, because of its discomfort to the patient and high cost, screening for early GC (EGC) is a major difficulty in clinical practice, particularly for asymptomatic individuals. Unfortunately, gastric precursor lesions such as intestinal metaplasia (IM), chronic atrophic gastritis (CAG), and persistent Helicobacter pylori (HP) infection increase the difficulty of screening for EGC. Furthermore, the standard serum biomarkers for GC, such as CEA, CA72-4, and CA19-9 achieve a low positive rate. Thus, it is critically important to develop new approaches for diagnosing EGC with high specificity and sensitivity.

Objective:

To study circulating exosomal lncRNA-GC1 as a potential biomarker for detection of gastric cancer.

Eligibility:

Participants from two medical centers in China

Design:

Investigators will use blood samples from participants in the two medical centers. Investigators will use samples from some who developed gastric cancer. The other samples will be from some who stayed cancer free in that time.

Participants already gave written informed consent.

Investigators will take exosomes from the samples and look for lncRNA-GC1.

Detailed Description

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Late detection is a major reason for the poor prognosis of patients with gastric cancer. For example, the proportion of patients diagnosed with early gastric cancer is as low as 9% in China. The survival rate of patients with early gastric cancer ranges from 60%-80% compared with 15%-24% of patients with advanced gastric cancer. It is therefore imperative to develop novel, relatively noninvasive approaches to improve early diagnosis of gastric cancer. Endoscopy has been considered as the gold standard for diagnosis of gastric cancer but endoscopy-based mass screening may not be feasible in relatively low-risk or less developed regions. Therefore, identification of biomarkers for early stage disease is crucial to in the development of effective screening strategies. With the recent advances in cancer genetics and assay technologies, this is an opportune time to discover minimally invasive, specific, and cost-effective biomarkers. The investigators' previous study has identified circulating exosomal lncRNA-GC1 as a potential biomarker for gastric cancer. The investigators then conducted this prospective study to further investigate the predictive value of circulating exosomal lncRNA-GC1 for early-detection and monitoring progression of gastric cancer.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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case

Gastric cancer cases from two medical centers in China

Measurement of levels of circulating exosomal lncRNA-GC1

Intervention Type DIAGNOSTIC_TEST

Each participant was enrolled to assess the levels of circulating exosomal lncRNA-GC1

control

Controls from two medical centers in China

Measurement of levels of circulating exosomal lncRNA-GC1

Intervention Type DIAGNOSTIC_TEST

Each participant was enrolled to assess the levels of circulating exosomal lncRNA-GC1

Interventions

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Measurement of levels of circulating exosomal lncRNA-GC1

Each participant was enrolled to assess the levels of circulating exosomal lncRNA-GC1

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Having signed informed consent
* Age≄ 18 years old
* Histologically confirmed gastric adenocarcinoma

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role collaborator

Lin Chen

OTHER

Sponsor Role lead

Responsible Party

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Lin Chen

Vice Director of Department of General Surgery, Chinese PLA General Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Qiying Song, MD

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Locations

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Xinxin Wang

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinxin Wang, MD, PhD

Role: CONTACT

86(10)-66938428

Facility Contacts

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XinXin Wang, MD

Role: primary

86-13354879656

Other Identifiers

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GC-biomarker

Identifier Type: -

Identifier Source: org_study_id

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