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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