Use of Circulating Exosomal LncRNA-GC1 to Monitor Gastric Cancer
UCELMGC
Use of Circulating Exosomal lncRNA-GC1 as Blood Biomarker for Early Detection and Monitoring Gastric Cancer
1 other identifier
observational
700
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
1 active site
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 Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 27, 2022
June 1, 2022
5 months
May 23, 2022
June 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of levels of circulating exosomal lncRNA-GC1
Levels of circulating exosomal lncRNA-GC1 are detected by RT-PCR
Through study completion, an average of 1 year
Study Arms (2)
case
Gastric cancer cases from two medical centers in China
control
Controls from two medical centers in China
Interventions
Each participant was enrolled to assess the levels of circulating exosomal lncRNA-GC1
Eligibility Criteria
Community Sample Shanxi - Hospital and community sample Beijing -Hospital
You may qualify if:
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
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
- Lin Chenlead
- Xijing Hospitalcollaborator
Study Sites (1)
Xinxin Wang
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Qiying Song, MD
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice Director of Department of General Surgery, Chinese PLA General Hospital
Study Record Dates
First Submitted
May 23, 2022
First Posted
May 31, 2022
Study Start
May 1, 2022
Primary Completion
October 1, 2022
Study Completion
December 1, 2023
Last Updated
June 27, 2022
Record last verified: 2022-06