Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer

Study Overview
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Brief Summary
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The primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.

Detailed Description
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Laparoscopic surgery represents a milestone for treatment of gastric and rectal cancer, with advantages of minimal invasion and rapid recovery compared to open approach. However, for progressive gastric and rectal cancer, laparoscopic approach has not been officially promoted by NCCN guideline (2015). Over the past decade, circulating tumor cells (CTCs), originated from a tumor cell, have been identified as potential blood-based biomarkers capable of providing prognostic and predictive Information. In the present study, the investigators utilize the CTCBIOPSY® system (YZYBIO Company, Wuhan, China), which has been approved by CFDA (Chinese Food and Drug Administration), to detect CTCs, and try to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.

Official Title
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Significance of Circulating Tumor Cells (CTC) Detected by the CTCBIOPSY System as Potential Blood-based Biomarkers in Providing Prognostic and Predictive Information for Surgical Treatment of Gastric and Rectal Cancer

Conditions
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Circulating Tumor Cells, Colorectal Cancer, Gastric Cancer

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Gastric cancer Inclusion Criteria: Gastric cancer of stage II/III Exclusion Criteria: History of malignant tumors Gastric cancer of stage Ⅳ Preoperative neoadjuvant chemotherapy History of upper abdominal surgery Severe other contradictions of surgery Rectal cancer Inclusion Criteria: Primary rectal carcinoma Single lesion No metastasis Sphincter-saving surgery available Exclusion Criteria: History of malignant tumors Acute bowel obstruction, bleeding or perforation Tumor over 6cm in diameter or in severe adhesion with surrounded tissues Severe other contradictions of surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open surgery of rectal cancer<br>Patients undergoing rectal cancer resection in an open approach | Procedure: Surgery<br>* Laparoscopic or open surgery for resection of gastric or rectal cancer<br>|
| Experimental: Laparoscopic surgery of rectal cancer<br>Patients undergoing rectal cancer resection in a laparoscopic approach | Procedure: Surgery<br>* Laparoscopic or open surgery for resection of gastric or rectal cancer<br>|
| Experimental: Open surgery of gastric cancer<br>Patients undergoing gastric cancer resection in an open approach | Procedure: Surgery<br>* Laparoscopic or open surgery for resection of gastric or rectal cancer<br>|
| Experimental: Laparoscopic surgery of gastric cancer<br>Patients undergoing gastric cancer resection in a laparoscopic approach | Procedure: Surgery<br>* Laparoscopic or open surgery for resection of gastric or rectal cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating tumor cell (CTC) test |  | Two years |