Prospectively Predict the Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy

Completed

• Conditions: Advanced Gastric Carcinoma; Immunotherapy

• Registration Number: NCT05334849
• Lead Sponsor: Lin Chen

Brief Summary

To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring immunotherapeutic outcomes of GC

Detailed Description

The investigator's previous work identified circulating exosomal lncRNA-GC1 as a GC-specific tumor burden marker and this novel biomarker showed promising efficiency in monitoring disease progression during treatment.

Hence in this stuty, the investigator plan to recruit a prospective cohort to support the conclusions, and provide biomarkers to realize predicting and monitoring immunotherapeutic outcomes of GC.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-19
• Primary Completion: 2022-08-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Having signed informed consent
• Age≥ 18 years old
• Histologically confirmed gastric adenocarcinoma
• Unresectable recurrent or metastatic disease
• Measurable disease according to the RECIST criteria
• Life expectancy of ≥3 month
• No prior chemotherapy of the study more than 4 weeks
• Immunotherapy regimens were included in the treatment

Exclusion Criteria

• Other previous malignancy within 5 year
• Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
• Pregnancy or lactation period
• Legal incapacity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Levels of circulating exosomal lncRNA-GC1	Circulating exosomal lncRNA-GC1 was detected, analysis and reported through study completion, average 1 year	Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.

Secondary Outcome Measures

Name	Time	Method
Survival outcomes of circulating exosomal lncRNA-GC1	up to 3 years	Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 detected by RT-PCR.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China