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Prospectively Predict the Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy

Sponsor
Lin Chen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05334849
Collaborator
(none)
80
Enrollment
1
Location
46.9
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Circulating exosomal lncRNA-GC1 detection

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospectively Predict the Efficacy of Precise Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy
Actual Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Levels of circulating exosomal lncRNA-GC1 [Circulating exosomal lncRNA-GC1 was detected, analysis and reported at the baseline]

    Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.

  2. Levels of circulating exosomal lncRNA-GC1 [Circulating exosomal lncRNA-GC1 was detected, analysis and reported through study completion, average 1 year]

    Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.

Secondary Outcome Measures

  1. Survival outcomes of circulating exosomal lncRNA-GC1 [up to 3 years]

    Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 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

  • 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Lin Chen

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:
NCT05334849
Other Study ID Numbers:
  • irBiomarker
First Posted:
Apr 19, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Jul 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
Immunotherapy response
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Jul 5, 2022