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

October 7, 2022 updated by: Lin Chen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients in this study were enrolled by the Department of General Surgery, Chinese PLA General Hospital for conventional therapy or clinical trials

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of circulating exosomal lncRNA-GC1
Time Frame: Circulating exosomal lncRNA-GC1 was detected, analysis and reported at the baseline
Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.
Circulating exosomal lncRNA-GC1 was detected, analysis and reported at the baseline
Levels of circulating exosomal lncRNA-GC1
Time Frame: 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.
Circulating exosomal lncRNA-GC1 was detected, analysis and reported through study completion, average 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival outcomes of circulating exosomal lncRNA-GC1
Time Frame: up to 3 years
Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 detected by RT-PCR.
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lin Chen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • irBiomarker

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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