Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05397548
Status:
UNKNOWN
Last Update Posted:
2022-06-27
First Post:
2022-05-23
Brief Title:
Use of Circulating Exosomal LncRNA-GC1 to Monitor Gastric Cancer
Sponsor:
Lin Chen
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Use of Circulating Exosomal lncRNA-GC1 as Blood Biomarker for Early Detection and Monitoring Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UCELMGC
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None