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NCT05647941 Clinical Trial

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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05647941
Other study ID # neo-Biomarker
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 30, 2022

Study information
Verified date December 2022
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 700
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Detection of levels of circulating EV-derived lncRNA-GC1
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.

Locations
Country Name City State
China Chinese PLA General Hospital Ethics Committee Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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