Gastric CancerNCT05498194
Computational Prediction and Experimental Validation of Gastric Cancer Associated Neoantigens
An observational study of Gastric Cancer and Neoantigens, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
This study is to develop methods for identification of neoantigens from patients with gastric cancer. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Gastric Cancer, Neoantigens
- What is being tested?
- ratio of predicted neoantigens
- How many people
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Aug 2022to 31 Dec 2023
- 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 15 to 18 years
- All sexes
- Child, Adult
Study population: All the patients who were diagnosed with adavanced gastric cancer and underwent surgical resection
Who may be able to join
- Male or Female patients aged 15 years and older
- Diagnosed with advanced gastric cancer (T2-4b/N0-3/M0-1 stage, according to the eighth edition of the American Joint Committee on Cancer TNM (AJCC TNM) system)
- Treatment-Naive
- Not known for other concomitant cancers
- Provide written informed consent
Who cannot join
- Insufficient tumor tissues (less than 1 cm3)
- Unable to sign informed consent
- Underwent treatment
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
This study is to develop methods for identification of neoantigens from patients with gastric cancer.
Read the detailed description
Gastric cancer (GC) is the fourth most common cancer type and one of the leading causes of cancer-related death in Vietnam. Immunotherapy using checkpoint inhibitors (CPI) in combination with certain types of chemotherapy has been clinically shown to offer survival benefits for patients diagnosed with advanced stomach cancer. However, clinical outcomes of CPI are associated with the quantity as well as the quality of neoantigens which arise due to mutations in coding regions of cancer associated genes. Such neoantigens can be presentable by cancer cells to the host adaptive immune system and activate antitumor responses. Hence, the identification of neoantigens would be of significance for immunotherapeutic approaches. Recent data published by the Tumor Neoantigen Selection Alliance (TESLA) indicate that a large proportion (98%) of predicted neoantigens are not immunogenic and ineffective in activating anti-tumor responses. In the present study, we aim to develop a comprehensive pipeline incorporating both computational prediction tools and experimental validation assays to enhance the accuracy of neoantigen identification.
- Conditions
- Gastric Cancer, Neoantigens
- Being tested
- ratio of predicted neoantigens
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ratio of predicted neoantigensDiagnostic test
10 ml of whole blood is collected from each patient prior surgery Fresh tumor tissue samples (~ 1cm3 ) are collected during surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The neoantigen landscape of patients with gastric cancer
The analysis of tumor DNA and RNA sequencing data will provide the mutational distribution of patients with gastric cancer, which could give rise to neoantigens. Of those, neoantigens derived from hotspot mutations in Vietnamese gastric cancer patients will be identified.
Measured: 3 months from the beginning of the study
Secondary outcomes (2)
The ratio of predicted neoantigens being presented by HLA-I
Computational pipelines will be employed to predict the pairing of neoantigens and HLA molecules. Subsequently, the ratio of those predicted neoantigens will be validated by co-immunoprecipitation with anti-HLA antibodies and mass spectrometry analysis for their binding to corresponding HLA molecules.
Measured: 6 months from the beginning of the study
The ratio of predicted neoantigens being immunogenic.
Immunoassays will be employed to identify neoantigens that could activate CD4 and CD8 T cells to kill tumor cells and serve as putative candidates for immunotherapy.
Measured: 12 months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start15 Aug 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498194
- Sponsor's protocol ID
- 62/GCN-HDDD
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Prediction and Experimental Validation of Gastric Cancer Associated Neoantigens
- ClinicalTrials.gov ID
- NCT05498194
- Acronym / sponsor ID
- 62/GCN-HDDD
- Conditions
- Gastric Cancer, Neoantigens
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Aug 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.
This study is to develop methods for identification of neoantigens from patients with gastric cancer.
Detailed description
Gastric cancer (GC) is the fourth most common cancer type and one of the leading causes of cancer-related death in Vietnam. Immunotherapy using checkpoint inhibitors (CPI) in combination with certain types of chemotherapy has been clinically shown to offer survival benefits for patients diagnosed with advanced stomach cancer. However, clinical outcomes of CPI are associated with the quantity as well as the quality of neoantigens which arise due to mutations in coding regions of cancer associated genes. Such neoantigens can be presentable by cancer cells to the host adaptive immune system and activate antitumor responses. Hence, the identification of neoantigens would be of significance for immunotherapeutic approaches. Recent data published by the Tumor Neoantigen Selection Alliance (TESLA) indicate that a large proportion (98%) of predicted neoantigens are not immunogenic and ineffective in activating anti-tumor responses. In the present study, we aim to develop a comprehensive pipeline incorporating both computational prediction tools and experimental validation assays to enhance the accuracy of neoantigen identification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All the patients who were diagnosed with adavanced gastric cancer and underwent surgical resection
Key inclusion criteria (5 listed)
- Male or Female patients aged 15 years and older
- Diagnosed with advanced gastric cancer (T2-4b/N0-3/M0-1 stage, according to the eighth edition of the American Joint Committee on Cancer TNM (AJCC TNM) system)
- Treatment-Naive
- Not known for other concomitant cancers
- Provide written informed consent
Key exclusion criteria (3 listed)
- Insufficient tumor tissues (less than 1 cm3)
- Unable to sign informed consent
- Underwent treatment
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 |
|---|---|---|
| ratio of predicted neoantigens10 ml of whole blood is collected from each patient prior surgery Fresh tumor tissue samples (~ 1cm3 ) are collected during surgery | Diagnostic test | – |
Primary outcome
The neoantigen landscape of patients with gastric cancer
Time frame: 3 months from the beginning of the study
The analysis of tumor DNA and RNA sequencing data will provide the mutational distribution of patients with gastric cancer, which could give rise to neoantigens. Of those, neoantigens derived from hotspot mutations in Vietnamese gastric cancer patients will be identified.
2 secondary outcomes
The ratio of predicted neoantigens being presented by HLA-I
Time frame: 6 months from the beginning of the study
The ratio of predicted neoantigens being immunogenic.
Time frame: 12 months from the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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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 Gastric Cancer and Neoantigens, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
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 5 inclusion and 3 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 11 Aug 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 Vietnam. 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?
Contact Long Vo Duy (+84.918133915, long.vd@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The neoantigen landscape of patients with gastric cancer (time frame: 3 months from the beginning of the study). 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 11 Aug 2022.