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

NCT ID: NCT05498194

Condition: Gastric Cancer
Neoantigens

Conditions: Official terms:
Stomach Neoplasms

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
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 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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. Male or Female patients aged 15 years and older 2. 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) 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: 18 Years

Locations:

Facility:
Name: University Medical Center Ho Chi Minh City

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

Start date: August 15, 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/NCT05498194

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