The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
Study Details
Study Description
Brief Summary
In resectable gastric cancer participants who received curative surgery, to early and more accurately detect peritoneal carcinomatosis or occult metastasis is important. Also, investigators will look at CTC numbers in different timings after operation, to investigate the possibility of early detection for peritoneal carcinomatosis or occult metastasis. Also, this study will correlate the relationship of CTC and participants' survival.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Circulating tumor cells (CTCs) are an emerging "liquid biopsy" that provide prognostic value for various types of solid cancer on early recurrence and survival. The evaluation of CTCs might be a useful strategy to predict tumor progression and prognosis in Gastric adenocarcinoma (GC). Previous study has shown that the frequency of CTC detection was higher in advanced GC than early GC, in poorly differentiated GC than well/moderately differentiated GC, and in GC with lymphatic metastasis than that without lymphatic metastasis. However, the impact of CTCs in the detection of PM in GC is still under debate. Peritoneal metastasis (PM) is highly related to recurrence and metastasis in GC; therefore, it was significantly related to disease free and overall survival of participants.
Consequently, several important questions and goals will be answered by this study:
To elucidate the clinical relationship between CTCs and PM in GCs before the operation; therefore, it could be an indicator of prophylactic during operation, which may possibly prolong the disease free and overall survival.
To establish a good model to follow-up a specific surface marker on CTCs, which could be possibly utilized as a more sensitive marker, comparing with CEA or image study, to more accurately detect the early recurrence or metastasis in GC.
To verify that dynamically monitoring CTCs status and changes during long-term follow-up and anti-cancer treatment are feasible and clinically meaningful to survival or treatment responses.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| single arm, observational arm Patients who received surgery will routinely followed up by pre-op CTC, post-op CTC until 6 months after surgery. |
Outcome Measures
Primary Outcome Measures
- Percentage of disease recurrence [Baseline]
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
- Percentage of disease recurrence [Post-operation within 3 days]
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
- Percentage of disease recurrence [Post-operation day 4 - 4 weeks]
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
- Percentage of disease recurrence [Post-operation 3 months]
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
- Percentage of disease recurrence [Post-operation 6 months]
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
Secondary Outcome Measures
- Percentage of peritoneal seedings [Baseline]
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
- Percentage of peritoneal seedings [Post-operation within 3 days]
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
- Percentage of peritoneal seedings [Post-operation day 4 - 4 weeks]
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
- Percentage of peritoneal seedings [Post-operation 3 months]
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
- Percentage of peritoneal seedings [Post-operation 6 months]
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
- overall survival time [Post-operation 1 year.]
To correlate the relationship of circulating tumor cells and long-term survival time.
- overall survival time [Post-operation 2 year.]
To correlate the relationship of circulating tumor cells and long-term survival time.
- Progression-free survival [Post-operation 1 year.]
To correlate the relationship of circulating tumor cells and Progression-free survival.
- Progression-free survival [Post-operation 2 year.]
To correlate the relationship of circulating tumor cells and Progression-free survival.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Enrolling 150 cases
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Stage I or more advanced gastric cancer, pathology proved
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Diagnosed at age ≥ 20 years
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Enrolled before surgery at the General Surgery Department, both inpatient and outpatient services.
Exclusion Criteria:
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Patient's refusal
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Poor compliance, unable to cooperate for blood sampling for CTC isolation as time schedule or clinical treatment or follow-up
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Difficult blood sampling
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No more needs for CTCs evaluation, decided by clinicians.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chang Gung Memorial Hospital | Taoyuan City | Taiwan | 333 |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
- Principal Investigator: Shih-Chun Chang, Chang Gung Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202100832B0