Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer
Primary Purpose
Circulating Tumor Cells, Colorectal Cancer, Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surgery
Sponsored by
About this trial
This is an interventional screening trial for Circulating Tumor Cells
Eligibility Criteria
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
Sites / Locations
- Qilu Hospital of Shandong University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Open surgery of rectal cancer
Laparoscopic surgery of rectal cancer
Open surgery of gastric cancer
Laparoscopic surgery of gastric cancer
Arm Description
Patients undergoing rectal cancer resection in an open approach
Patients undergoing rectal cancer resection in a laparoscopic approach
Patients undergoing gastric cancer resection in an open approach
Patients undergoing gastric cancer resection in a laparoscopic approach
Outcomes
Primary Outcome Measures
Disease-free survival
Secondary Outcome Measures
Circulating tumor cell (CTC) test
Full Information
NCT ID
NCT02955173
First Posted
November 2, 2016
Last Updated
October 2, 2021
Sponsor
Qilu Hospital of Shandong University
Collaborators
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02955173
Brief Title
Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
August 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qilu Hospital of Shandong University
Collaborators
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circulating Tumor Cells, Colorectal Cancer, Gastric Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
467 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open surgery of rectal cancer
Arm Type
Experimental
Arm Description
Patients undergoing rectal cancer resection in an open approach
Arm Title
Laparoscopic surgery of rectal cancer
Arm Type
Experimental
Arm Description
Patients undergoing rectal cancer resection in a laparoscopic approach
Arm Title
Open surgery of gastric cancer
Arm Type
Experimental
Arm Description
Patients undergoing gastric cancer resection in an open approach
Arm Title
Laparoscopic surgery of gastric cancer
Arm Type
Experimental
Arm Description
Patients undergoing gastric cancer resection in a laparoscopic approach
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Laparoscopic or open surgery for resection of gastric or rectal cancer
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Circulating tumor cell (CTC) test
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanyuan Hu, M.D. Ph.D.
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26085388
Citation
Benson AB 3rd, Venook AP, Bekaii-Saab T, Chan E, Chen YJ, Cooper HS, Engstrom PF, Enzinger PC, Fenton MJ, Fuchs CS, Grem JL, Grothey A, Hochster HS, Hunt S, Kamel A, Kirilcuk N, Leong LA, Lin E, Messersmith WA, Mulcahy MF, Murphy JD, Nurkin S, Rohren E, Ryan DP, Saltz L, Sharma S, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Gregory KM, Freedman-Cass D. Rectal Cancer, Version 2.2015. J Natl Compr Canc Netw. 2015 Jun;13(6):719-28; quiz 728. doi: 10.6004/jnccn.2015.0087.
Results Reference
background
PubMed Identifier
27618023
Citation
Lowes LE, Bratman SV, Dittamore R, Done S, Kelley SO, Mai S, Morin RD, Wyatt AW, Allan AL. Circulating Tumor Cells (CTC) and Cell-Free DNA (cfDNA) Workshop 2016: Scientific Opportunities and Logistics for Cancer Clinical Trial Incorporation. Int J Mol Sci. 2016 Sep 8;17(9):1505. doi: 10.3390/ijms17091505.
Results Reference
background
Links:
URL
http://www.ctcbiopsy.com/
Description
Introduction of the CTCBIOPSY system
Learn more about this trial
Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer
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