Computational Prediction and Experimental Validation of Esophageal Cancer Associated Neoantigens
1 other identifier
observational
50
1 country
1
Brief Summary
This study is to develop computational pipelines and experimental validation assays for improving the identification of neoantigens from patients with esophageal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedAugust 11, 2022
August 1, 2022
1.3 years
August 9, 2022
August 9, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
12 months from the begining of study
Interventions
10 ml of whole blood is collected from each patient prior surgery Fresh tumor tissue samples (\~ 1cm3 ) are collected during surgery
Eligibility Criteria
All the patients who were diagnosed with adavanced esophageal cancer and underwent surgical resection
You may qualify if:
- 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
You may not qualify if:
- Insufficient tumor tissues (less than 1 cm3 )
- Unable to sign informed consent
- Underwent treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2022
First Posted
August 11, 2022
Study Start
September 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
August 11, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share