Clinical trial NCT06023121: Use of a Liquid Biopsy Signature to Detect Early-onset Gastric Cancer
Official title: Use of a Liquid Biopsy Signature as Blood Biomarker for Early Detection and Monitoring Early-onset Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample Shanxi - Hospital and community sample Beijing -Hospital

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.

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

Primary outcomes:
measure: Detection of levels of an exosome-based liquid biopsy signature
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital Ethics Committee
state: Beijing
Study officials:
References: