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

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05647941
Collaborator
(none)
700
Enrollment
1
Location
59.9
Anticipated Duration (Months)
11.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Detection of levels of circulating EV-derived lncRNA-GC1

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 Design

Study Type:
Observational
Anticipated Enrollment :
700 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Non-invasive Response Assessment of Neo-adjuvant Chemotherapy in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Detection of levels of circulating exosomal lncRNA-GC1 [Through study completion, an average of 1 year]

    Levels of circulating exosomal lncRNA-GC1 are detected by RT-PCR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Having signed informed consent

  • Ageā‰„ 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese PLA General Hospital Ethics Committee Beijing Beijing China 100853

Sponsors and Collaborators

  • Chinese PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lin Chen, Director of Department of General Surgery, Chinese PLA General Hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT05647941
Other Study ID Numbers:
  • neo-Biomarker
First Posted:
Dec 13, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lin Chen, Director of Department of General Surgery, Chinese PLA General Hospital, Chinese PLA General Hospital
Circulating exosomal lncRNA-GC1
Advanced Gastric Carcinoma
treatment response
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Dec 14, 2022