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Clinical Trials/NCT06023121
NCT06023121
Completed
Not Applicable

Use of a Liquid Biopsy Signature as Blood Biomarker for Early Detection and Monitoring Early-onset Gastric Cancer

Chinese PLA General Hospital1 site in 1 country800 target enrollmentJanuary 1, 2018
ConditionsGastric Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Chinese PLA General Hospital
Enrollment
800
Locations
1
Primary Endpoint
Detection of levels of an exosome-based liquid biopsy signature
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Early-onset gastric cancer (EOGC) is a lethal malignancy with a poor prognosis. It differs from late-onset gastric cancer (LOGC) in clinical and molecular characteristics. The current strategies for EOGC detection have certain limitations in diagnostic performance due to the rising trend in EOGC. Hence, identifying novel EOGC bioindicators is crucial.

Detailed Description

Due to widespread gastric cancer (GC) detection efforts and timely interventions (removal of precancerous lesions and early-stage GC), the GC-associated mortality rate has declined worldwide. However, epidemiological studies show rising GC incidences among young adults (\< 50 years old) without familial or hereditary origin. This illness, known as early-onset GC (EOGC), comprises 20-30% of new GC diagnoses, mainly among individuals aged 30-40 years; the median overall survival time is 11.7 months. Although the underlying cause behind this trend is poorly understood, there is a general understanding that EOGC epidemiologically, biologically, and pathologically differs from late-onset GC (LOGC, ≥ 50 years). Therefore, EOGC patients require clinical assessment and intervention distinct from those applied in LOGC. Of note, several population-based epidemiological studies have suggested that EOGC patients exhibit significantly different behaviors from LOGC patients. EOGC patients are more likely to have earlier lymph node and distal metastasis than LOGC patients during disease progression. These tough challenges raise clinical concerns: EOGC is more aggressive than LOGC; thus, a delayed diagnosis can severely affect patient survival outcomes. Moreover, the current approaches to GC detection, such as CEA, HP serology, and pepsinogen (PG), are insufficient for detecting early-stage GC and have yet to be investigated in young individuals with EOGC. Accordingly, these limitations strongly underscore the necessity to establish potent alternative indicators that facilitate the timely detection of EOGC.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
August 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lin Chen

Director of department of General Surgery

Chinese PLA General Hospital

Eligibility Criteria

Inclusion Criteria

  • Having signed informed consent
  • 50 years old ≥ 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

Outcomes

Primary Outcomes

Detection of levels of an exosome-based liquid biopsy signature

Time Frame: Through study completion, an average of 3 year

A three exo-LR (NALT1, PTENP1, and HOTTIP) liquid biopsy signature was developed for EOGC detection.

Study Sites (1)

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