Use of a Liquid Biopsy Signature to Detect Early-onset Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06023121
• Other study ID #: EOGC-biomarker
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2023
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 30, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Diagnostic Test:
• Measurement of levels of an exosome-based liquid biopsy signature
Each participant was enrolled to assess the levels of an exosome-based liquid biopsy signature

Locations

Country	Name	City	State
China	Chinese PLA General Hospital Ethics Committee	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of levels of an exosome-based liquid biopsy signature	A three exo-LR (NALT1, PTENP1, and HOTTIP) liquid biopsy signature was developed for EOGC detection.	Through study completion, an average of 3 year