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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955173
• Other study ID #: 2016YFC0106003
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 3, 2021

Study information

• Verified date: October 2021
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: August 3, 2021
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Gastric cancer

Inclusion Criteria:

• Gastric cancer of stage II/III

Exclusion Criteria:

• History of malignant tumors
• Gastric cancer of stage ?
• 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

Related Conditions & MeSH terms

• Circulating Tumor Cells
• Colorectal Cancer
• Gastric Cancer
• Neoplastic Cells, Circulating

Intervention

Procedure:
• Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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). pii: E1505. doi: 10.3390/ijms17091505. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		Two years
Secondary	Circulating tumor cell (CTC) test		Two years

External Links

•   Introduction of the CTCBIOPSY system