Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer
NCT ID: NCT02955173
Last Updated: 2021-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
467 participants
INTERVENTIONAL
2016-12-31
2021-08-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Open surgery of rectal cancer
Patients undergoing rectal cancer resection in an open approach
Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
Laparoscopic surgery of rectal cancer
Patients undergoing rectal cancer resection in a laparoscopic approach
Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
Open surgery of gastric cancer
Patients undergoing gastric cancer resection in an open approach
Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
Laparoscopic surgery of gastric cancer
Patients undergoing gastric cancer resection in a laparoscopic approach
Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
Interventions
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Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
Eligibility Criteria
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Inclusion Criteria
* Primary rectal carcinoma
* Single lesion
* No metastasis
* Sphincter-saving surgery available
Exclusion Criteria
* Gastric cancer of stage Ⅳ
* Preoperative neoadjuvant chemotherapy
* History of upper abdominal surgery
* Severe other contradictions of surgery
Rectal cancer
* 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
18 Years
80 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Responsible Party
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Sanyuan Hu
Dr.& Prof.
Principal Investigators
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Sanyuan Hu, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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References
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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.
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.
Related Links
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Introduction of the CTCBIOPSY system
Other Identifiers
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2016YFC0106003
Identifier Type: -
Identifier Source: org_study_id
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