NCT05647941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

5 years

First QC Date

December 4, 2022

Last Update Submit

December 12, 2022

Conditions

Gastric CancerChemotherapy Effect

Keywords

Circulating exosomal lncRNA-GC1Advanced Gastric Carcinomatreatment response

Outcome Measures

Primary Outcomes (1)

  • Detection of levels of circulating exosomal lncRNA-GC1

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

    Through study completion, an average of 1 year

Interventions

Detection of levels of circulating EV-derived lncRNA-GC1DIAGNOSTIC_TEST

For patients with gastric cancer receiving neo-adjuvant chemotherapy, the dynamic changes of EV-derived lncRNA-GC1 was detected to identify whether is can serve as a monitoring biomarker for treatment response.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community Sample Shanxi - Hospital and community sample Beijing -Hospital

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital Ethics Committee

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of General Surgery, Chinese PLA General Hospital

Study Record Dates

First Submitted

December 4, 2022

First Posted

December 13, 2022

Study Start

January 1, 2018

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Locations

CN(1)