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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02955173
Enrollment
467
Registered
2016-11-04
Start date
2016-12-31
Completion date
2021-08-03
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor Cells, Colorectal Cancer, Gastric Cancer

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.

Interventions

PROCEDURESurgery

Laparoscopic or open surgery for resection of gastric or rectal cancer

Sponsors

Peking University People's Hospital
CollaboratorOTHER
Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Disease-free survivalTwo years

Secondary

MeasureTime frame
Circulating tumor cell (CTC) testTwo years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026