Neo-adjuvant Chemotherapy Evluation in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1

December 12, 2022 updated by: Lin Chen, Chinese PLA General Hospital

Non-invasive Response Assessment of Neo-adjuvant Chemotherapy in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1

The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a non-invasive biomarker for monitoring the neo-adjuvant chemotherapy response for personalized medicine for gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The LncRNA-GC1could noninvasively track dynamics of tumor burden and has been proposed as a real-time biomarker that can provide both predictive and prognostic values. But the value in monitoring the neo-adjuvant chemotherapy response is unclear. The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a monitoring biomarker for patients with gastric cancer receiving neo-adjuvant chemotherapy.

Study Type

Observational

Enrollment (Anticipated)

700

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
        • Recruiting
        • Chinese PLA General Hospital Ethics Committee

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community Sample Shanxi - Hospital and community sample Beijing -Hospital

Description

Inclusion Criteria:

  • Having signed informed consent
  • Age≥ 18 years old
  • Histologically confirmed gastric adenocarcinoma
  • radiographically identified as advanced gastric cancer

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of levels of circulating exosomal lncRNA-GC1
Time Frame: Through study completion, an average of 1 year
Levels of circulating exosomal lncRNA-GC1 are detected by RT-PCR
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

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)

January 1, 2018

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

December 4, 2022

First Submitted That Met QC Criteria

December 4, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • neo-Biomarker

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data may be shared until the final results published.

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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