Genomic Evolution of Metastasis in Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Genomic Evolution of Metastasis in Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05061082
• Other study ID #: 80/GCN-HDDD 2021
• Status: Recruiting
• Start date: October 26, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2022
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: Long Duy Vo, MD, PhD
• Phone: +84. 918133915
• Email: long.vd[@]umc.edu.vn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to track tumor evolution of regional and distant metastases in gastric cancer using the Next Generation Sequencing technologies.

Description:

Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Metastasis is the leading cause of death in gastric cancer patients, with median overall survival of less than 1 year. Currently, there is no effective treatment because the molecular mechanism of metastasis remains unclear. The aim of this study is to use advanced NGS technologies to dissect the genomic changes (genetic, epigenetic and transcriptional changes) of the primary tumor and associated metastatic sites of the same patients. With that, the investigators can reconstruct the clonal evolution from primary tumor to metastasis, identify key pathways governing metastasis development that can be targeted for future therapeutic development.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or Female patients aged 18 years and older

2. Histologically proven primary gastric adenocarcinoma and clinical evidence of metastasis (N1-3M1)

3. Biopsies can be taken at multiple sites

4. No known other concomitant cancer diagnosis

5. Signed informed consent

Exclusion Criteria:

1. Gastric adnocarcinoma cannot be confirmed primary

2. Unable to undergo biopsy or surgery

Related Conditions & MeSH terms

• Gastric Cancer
• Metastasis
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Stomach Neoplasms

Locations

Country	Name	City	State
Vietnam	University Medical Center Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Ho Chi Minh City (UMC)

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic and epigenetic changes of the tumor	Ultra-deep NGS of the primary tumor and associated metastatic sites from the same patients to identify mechanism governing metastasis development	3 months after surgery