Esophageal CancerNCT05498168
Computational Prediction and Experimental Validation of Esophageal Cancer Associated Neoantigens
An observational study of Esophageal Cancer and Neoantigen, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
This study is to develop computational pipelines and experimental validation assays for improving the identification of neoantigens from patients with esophageal cancer. Read more about this study
- Who is it for?
- Ages 15 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer, Neoantigen
- What is being tested?
- ratio of predicted neoantigens
- How many people
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 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 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All the patients who were diagnosed with adavanced esophageal cancer and underwent surgical resection
Who may be able to join
- Male or Female patients aged 18 years and older
- Diagnosed with advanced esophageal cancer
- 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.
Thong Dang Quang contact
Vietnam1 site
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
This study is to develop computational pipelines and experimental validation assays for improving the identification of neoantigens from patients with esophageal cancer.
Read the detailed description
Esophageal cancer (EC) is the common malignant tumor with poor survival. The long-term surival rate of patients with advanced EC stages has not been improved with multidisciplinary treatments including surgery and chemotherapy and radiation. Recently, immunotherapy approaches using checkpoint inhibitors (CPI), cancer vaccine, and adoptive T cell therapy have improved survival outcomes of EC patients. The clinical outcomes are associated with expression levels as well as the immunogenicity of neoantigens which arise from soma mutations. Therefore, the identification of immunogenic neoantigens is essential for achieving effective therapies. Recent data published by the Tumor Neoantigen Selection Alliance (TESLA) show that the majority (98%) of predicted neoantigens are lack of immunogenicity and ineffective in activating antitumor immune responses. In our study, we aim to develop a pipeline with both computational prediction tools and experimental validation assays to enhance the accuracy of neoantigen identification.
- Conditions
- Esophageal Cancer, Neoantigen
- Being tested
- ratio of predicted neoantigens
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ratio of predicted neoantigensGenetic
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 esophageal cancer
The analysis of tumor DNA and RNA sequencing data will provide the mutational distribution of patients with esophageal cancer, which could give rise to neoantigens. Of those, neoantigens derived from hotspot mutations in Vietnamese esophageal cancer patients will be identified.
Measured: 3 months from the begining of study
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 begining of 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 begining of 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 start1 Sep 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 Esophageal 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
- NCT05498168
- Sponsor's protocol ID
- 61/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 Esophageal Cancer Associated Neoantigens
- ClinicalTrials.gov ID
- NCT05498168
- Acronym / sponsor ID
- 61/GCN-HDDD
- Conditions
- Esophageal Cancer, Neoantigen
- 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
- 1 Sep 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 computational pipelines and experimental validation assays for improving the identification of neoantigens from patients with esophageal cancer.
Detailed description
Esophageal cancer (EC) is the common malignant tumor with poor survival. The long-term surival rate of patients with advanced EC stages has not been improved with multidisciplinary treatments including surgery and chemotherapy and radiation. Recently, immunotherapy approaches using checkpoint inhibitors (CPI), cancer vaccine, and adoptive T cell therapy have improved survival outcomes of EC patients. The clinical outcomes are associated with expression levels as well as the immunogenicity of neoantigens which arise from soma mutations. Therefore, the identification of immunogenic neoantigens is essential for achieving effective therapies. Recent data published by the Tumor Neoantigen Selection Alliance (TESLA) show that the majority (98%) of predicted neoantigens are lack of immunogenicity and ineffective in activating antitumor immune responses. In our study, we aim to develop a pipeline with 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 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients who were diagnosed with adavanced esophageal cancer and underwent surgical resection
Key inclusion criteria (5 listed)
- Male or Female patients aged 18 years and older
- Diagnosed with advanced esophageal cancer
- 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 | Genetic | – |
Primary outcome
The neoantigen landscape of patients with esophageal cancer
Time frame: 3 months from the begining of study
The analysis of tumor DNA and RNA sequencing data will provide the mutational distribution of patients with esophageal cancer, which could give rise to neoantigens. Of those, neoantigens derived from hotspot mutations in Vietnamese esophageal cancer patients will be identified.
The ratio of predicted neoantigens being presented by HLA-I
Time frame: 6 months from the begining of study
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.
The ratio of predicted neoantigens being immunogenic
Time frame: 12 months from the begining of study
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.
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.
Thong Dang Quang contact
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 Esophageal Cancer and Neoantigen, 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, PhD (+84.8.39525656, 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 esophageal cancer (time frame: 3 months from the begining of study). The study lists 3 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 11 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.