Advanced Gastric CarcinomaNCT05334849
Prospectively Predict the Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy
An observational study of Advanced Gastric Carcinoma and Immunotherapy, run by Lin Chen at 1 site in China.
Trial summary
To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring immunotherapeutic outcomes of GC Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Gastric Carcinoma, Immunotherapy
- What is being tested?
- Circulating exosomal lncRNA-GC1 detection
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 30 Sep 2022
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Other previous malignancy within 5 year
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
- Pregnancy or lactation period
- Legal incapacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospectively Predict the Efficacy of Precise Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy
To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring immunotherapeutic outcomes of GC
Read the 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.
- Conditions
- Advanced Gastric Carcinoma, Immunotherapy
- Being tested
- Circulating exosomal lncRNA-GC1 detection
- Keywords
- Circulating exosomal lncRNA-GC1, Advanced Gastric Carcinoma, Immunotherapy response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating exosomal lncRNA-GC1 detectionDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of circulating exosomal lncRNA-GC1
Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.
Measured: 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.
Measured: 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
Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 detected by RT-PCR.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Nov 2018
- Primary completion30 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Lin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334849
- Sponsor's protocol ID
- irBiomarker
- Status last verified
- Oct 2022
- First submitted
- 6 Apr 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospectively Predict the Efficacy of Precise Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy
- ClinicalTrials.gov ID
- NCT05334849
- Acronym / sponsor ID
- irBiomarker
- Conditions
- Advanced Gastric Carcinoma, Immunotherapy
- Keywords
- Circulating exosomal lncRNA-GC1, Advanced Gastric Carcinoma, Immunotherapy response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lin ChenUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring immunotherapeutic outcomes of GC
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- Having signed informed consent
- Age≥ 18 years old
- Histologically confirmed gastric adenocarcinoma
- Unresectable recurrent or metastatic disease
- Measurable disease according to the RECIST criteria
Key exclusion criteria (4 listed)
- Other previous malignancy within 5 year
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
- Pregnancy or lactation period
- Legal incapacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating exosomal lncRNA-GC1 detectionCollect 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. | Device | – |
Primary outcome
Levels of circulating exosomal lncRNA-GC1
Time frame: 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.
Levels of circulating exosomal lncRNA-GC1
Time frame: 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.
1 secondary outcome
Survival outcomes of circulating exosomal lncRNA-GC1
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Gastric Carcinoma and Immunotherapy, run by Lin Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of circulating exosomal lncRNA-GC1 (time frame: Circulating exosomal lncRNA-GC1 was detected, analysis and reported at the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.