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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
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Circulating Tumor Cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 2, 2016
Last Updated
October 2, 2021
Sponsor
Qilu Hospital of Shandong University
Collaborators
Peking University People's Hospital
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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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