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

NCT05334849 | Completed DMC

• 1 other identifier: irBiomarker
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Gastric Carcinoma; Immunotherapy

Keywords

Circulating exosomal lncRNA-GC1; Advanced Gastric Carcinoma; Immunotherapy response

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Survival outcomes of circulating exosomal lncRNA-GC1

  up to 3 years

Interventions

Circulating exosomal lncRNA-GC1 detection DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: 18 Years and older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients in this study were enrolled by the Department of General Surgery, Chinese PLA General Hospital for conventional therapy or clinical trials

You may qualify if:

• 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

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

Sponsors & Collaborators

• Lin Chen: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of General Surgery, Chinese PLA General Hospital

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 19, 2022
• Study Start: November 1, 2018
• Primary Completion: August 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

CN (1)