Clinical trial NCT05397548: Use of Circulating Exosomal LncRNA-GC1 to Monitor Gastric Cancer
Official title: Use of Circulating Exosomal lncRNA-GC1 as Blood Biomarker for Early Detection and Monitoring Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: Circulating exosomal lncRNA-GC1
Advanced Gastric Carcinoma
early detection
progression
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Xijing Hospital
First posted: 2022-05-31
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample Shanxi - Hospital and community sample Beijing -Hospital

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of levels of circulating exosomal lncRNA-GC1
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xinxin Wang
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Qiying Song, MD
role: STUDY_DIRECTOR
References: