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OpenTrials
Completed

NCT Number: NCT02955173

Significance of Circulating Tumor Cells in the 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

Laparoscopic or open surgery for resection of gastric or rectal cancer

Primary outcomes

  1. Disease-free survival

    Time frame: Two years

Secondary outcomes

  1. Circulating tumor cell (CTC) test

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Peking University People's Hospital

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Nov 4, 2016
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.