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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05334849
Other study ID # irBiomarker
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date September 30, 2022

Study information

Verified date October 2022
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 30, 2022
Est. primary completion date August 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 - 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 Design


Intervention

Device:
Circulating exosomal lncRNA-GC1 detection
Collect peripheral blood sample of 80 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect circulating exosomal lncRNA-GC1. Tumor response evaluation will be performed after two cycles of immunotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lin Chen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Levels of circulating exosomal lncRNA-GC1 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
Primary Levels of circulating exosomal lncRNA-GC1 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 Survival outcomes of circulating exosomal lncRNA-GC1 Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 detected by RT-PCR. up to 3 years
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