Skip to main content
Clinical Trials/NCT05498168
NCT05498168
Unknown
Not Applicable

Computational Prediction and Experimental Validation of Esophageal Cancer Associated Neoantigens

University Medical Center Ho Chi Minh City (UMC)1 site in 1 country50 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
University Medical Center Ho Chi Minh City (UMC)
Enrollment
50
Locations
1
Primary Endpoint
The neoantigen landscape of patients with esophageal cancer
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Medical Center Ho Chi Minh City (UMC)
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Insufficient tumor tissues (less than 1 cm3 )
  • Unable to sign informed consent
  • Underwent treatment

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials