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Trial Title: Computational Prediction and Experimental Validation of Esophageal Cancer Associated Neoantigens

NCT ID: NCT05498168

Condition: Esophageal Cancer
Neoantigen

Conditions: Official terms:
Esophageal Neoplasms

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Genetic
Intervention name: ratio of predicted neoantigens
Description: 10 ml of whole blood is collected from each patient prior surgery Fresh tumor tissue samples (~ 1cm3 ) are collected during surgery

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.

Criteria for eligibility:

Study pop:
All the patients who were diagnosed with adavanced esophageal cancer and underwent surgical resection

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. Male or Female patients aged 18 years and older 2. Diagnosed with advanced esophageal cancer 3. Treatment-Naive 4. Not known for other concomitant cancers 5. Provide written informed consent Exclusion Criteria: 1. Insufficient tumor tissues (less than 1 cm3 ) 2. Unable to sign informed consent 3. Underwent treatment

Gender: All

Minimum age: 15 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University Medical Center Ho Chi Minh City

Address:
City: Ho Chi Minh City
Zip: 700000
Country: Vietnam

Start date: September 1, 2022

Completion date: December 31, 2023

Lead sponsor:
Agency: University Medical Center Ho Chi Minh City (UMC)
Agency class: Other

Source: University Medical Center Ho Chi Minh City (UMC)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05498168

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