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

NCT ID: NCT02955173

Last Updated: 2021-10-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

467 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-08-03

Brief Summary

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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

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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.

Conditions

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Circulating Tumor Cells Colorectal Cancer Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Open surgery of rectal cancer

Patients undergoing rectal cancer resection in an open approach

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Gastric cancer of stage II/III


* Primary rectal carcinoma
* Single lesion
* No metastasis
* Sphincter-saving surgery available

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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Sanyuan Hu

Dr.& Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

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.

Reference Type BACKGROUND
PMID: 26085388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27618023 (View on PubMed)

Related Links

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http://www.ctcbiopsy.com/

Introduction of the CTCBIOPSY system

Other Identifiers

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2016YFC0106003

Identifier Type: -

Identifier Source: org_study_id

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