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

October 2, 2021 updated by: Sanyuan Hu, Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

467

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Circulating tumor cell (CTC) test
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Peking University People's Hospital

Investigators

  • Principal Investigator: Sanyuan Hu, M.D. Ph.D., Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

August 3, 2021

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016YFC0106003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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