Advanced Gastric AdenocarcinomaNCT04993378
Prospectively Predict the Efficacy of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy
An observational study of Advanced Gastric Adenocarcinoma and Immunotherapy, run by Shen Lin at 1 site in China.
Trial summary
To vertify the function of EV-score on predicting \& monitoring immunotherapeutic outcomes of GC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastric Adenocarcinoma, Immunotherapy
- What is being tested?
- EV-array
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 30 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients in this study were enrolled by the Department of gastrointestinal oncology, Peking University Cancer Hospital \& Institute 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.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing
lin shen, MD, (86)10-88196175, lin100@medmail.com.cn
lin shen, MD
About this study
Official title: A Clinical Study Initiated by Investigator:Prospectively Predict the Efficacy of Precise Treatment of Gastrointestinal Tumors Based on Peripheral Blood Multi-omics Liquid Biopsy
To vertify the function of EV-score on predicting \& monitoring immunotherapeutic outcomes of GC
Read the detailed description
Our previous work identified four plasma EV-derived proteins and combined them to generate a signature score that robustly predicting immunotherapeutic outcomes at baseline and dynamically monitoring disease progressions along with the whole treatment.
Hence in this stuty, we plan to recruit a prospective cohort to support our conclusions, and provide possible method to realize predicting and monitoring immunotherapeutic outcomes of GC.
- Conditions
- Advanced Gastric Adenocarcinoma, Immunotherapy
- Being tested
- EV-array
- Keywords
- plasma-based liquid biopsy protein biomarker, extracellular vesicles, protein biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV-arrayDevice
Collect peripheral blood sample of 40 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect EV-score by EV-array. Tumor response evaluation will be performed after two cycles of chemotherapy 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.
| Study group | Role | What they receive |
|---|---|---|
| GC patients receiving immunotherapy | Not described Receives: Device: EV-array |
What is being measured
The primary outcome is the main question the study is designed to answer.
EV-Score
EV-Score was calculated by the expression level of four tumor-associated proteins on plasma EV
Measured: EV-Score was detected, analysis and reported at the baseline of the treatment.
Secondary outcomes (1)
Survival significance of EV-Score
Analysis patients' survival with different EV-Score.
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 posted6 Aug 2021
- Study start1 Nov 2018
- Primary completion30 Apr 2021
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric AdenocarcinomaStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993378
- Sponsor's protocol ID
- CGOG-EV-1001
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- 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 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Initiated by Investigator:Prospectively Predict the Efficacy of Precise Treatment of Gastrointestinal Tumors Based on Peripheral Blood Multi-omics Liquid Biopsy
- ClinicalTrials.gov ID
- NCT04993378
- Acronym / sponsor ID
- CGOG-EV-1001
- Conditions
- Advanced Gastric Adenocarcinoma, Immunotherapy
- Keywords
- plasma-based liquid biopsy protein biomarker, extracellular vesicles, protein biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shen LinUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 6 Aug 2021 (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 EV-score on predicting \& monitoring immunotherapeutic outcomes of GC
Detailed description
Our previous work identified four plasma EV-derived proteins and combined them to generate a signature score that robustly predicting immunotherapeutic outcomes at baseline and dynamically monitoring disease progressions along with the whole treatment.
Hence in this stuty, we plan to recruit a prospective cohort to support our conclusions, and provide possible method to realize predicting and monitoring immunotherapeutic outcomes of GC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC patients receiving immunotherapy | – | Device: EV-array |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in this study were enrolled by the Department of gastrointestinal oncology, Peking University Cancer Hospital \& Institute 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 |
|---|---|---|
| EV-arrayCollect peripheral blood sample of 40 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect EV-score by EV-array. Tumor response evaluation will be performed after two cycles of chemotherapy 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 | GC patients receiving immunotherapy |
Primary outcome
EV-Score
Time frame: EV-Score was detected, analysis and reported at the baseline of the treatment.
EV-Score was calculated by the expression level of four tumor-associated proteins on plasma EV
1 secondary outcome
Survival significance of EV-Score
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- 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.
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 Adenocarcinoma and Immunotherapy, run by Shen Lin 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: status not confirmed, as of the sponsor's last update on 6 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EV-Score (time frame: EV-Score was detected, analysis and reported at the baseline of the treatment.). 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 6 Aug 2021.