Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy Study Description
Study Details
Study Description
Brief Summary
This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Patients at early stages undergo radical gastrectomy with curative intent, but the remaining tumor cells, termed as minimal residual disease (MRD), can later cause relapse. Conventional methods to monitor MRD such as imaging and blood tests for biomarkers such as CEA are not sensitive and specific enough. ctDNA has recently emerged as a promising noninvasive marker with high accuracy to monitor MRD and detect relapse in many cancers such as breast and colorectal cancers. However, its application in gastric cancer has not been extensively evaluated. Therefore, this study aims to use advanced NGS technologies to detect ctDNA in liquid biopsy as a biomarker to monitor MRD after radical gastrectomy.
Study Design
Outcome Measures
Primary Outcome Measures
- The sensitivity of MRD detection using ctDNA as the biomarker [2 years after surgery]
The percentage of positive ctDNA detection among participants who experience disease recurrence or metastasis
- The specificity of MRD detection using ctDNA as the biomarker [2 years after surgery]
The percentage of positive ctDNA detection among participants who do not experience disease recurrence or metastasis
Secondary Outcome Measures
- Leading time between ctDNA detection and cancer recurrence detected by conventional methods [2 years after surgery]
Time is measured between first positive ctDNA detection and first cancer recurrence detected by conventional methods
- Mean ctDNA level (MTM/ml) of gastric cancer before operation [Within 14 days before operation]
The mean ctDNA level in gastric cancer patients before operation
- Mutation profile of gastric cancer [Within 14 days before operation]
Profiling of the most frequent gene mutations
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or Female patients aged 18 years and older
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Histologically proven primary gastric adenocarcinoma before surgery
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Clinical stage is locally advanced cT2-4a any N and M0
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In initial evaluation, patient can undergo radical gastrectomy and lymphadenectomy
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No preoperative therapy, including chemotherapy and radiotherapy
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No known cancer diagnosis within last five years
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Signed informed consent
Exclusion Criteria:
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Gastrectomy cannot be achieved during operation due to metastasis
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Patient fails to follow-up and provide postoperative samples
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Ho Chi Minh City | Ho Chi Minh City | Vietnam | 700000 |
Sponsors and Collaborators
- University Medical Center Ho Chi Minh City (UMC)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 81/GCN-HDDD 2021