The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
Does Circulating Tumor Cells Provide Diagnostic and Prognostic Roles in Peritoneal Carcinomatosis, Recurrence and Metastasis in Gastric Cancer, Pre-operatively and Postoperatively?
1 other identifier
observational
150
1 country
1
Brief Summary
In resectable gastric cancer participants who received curative surgery, to early and more accurately detect peritoneal carcinomatosis or occult metastasis is important. Also, investigators will look at CTC numbers in different timings after operation, to investigate the possibility of early detection for peritoneal carcinomatosis or occult metastasis. Also, this study will correlate the relationship of CTC and participants' survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedMarch 2, 2023
January 1, 2023
3 years
February 8, 2023
February 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Percentage of disease recurrence
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
Baseline
Percentage of disease recurrence
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
Post-operation within 3 days
Percentage of disease recurrence
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
Post-operation day 4 - 4 weeks
Percentage of disease recurrence
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
Post-operation 3 months
Percentage of disease recurrence
Circulating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.
Post-operation 6 months
Secondary Outcomes (9)
Percentage of peritoneal seedings
Baseline
Percentage of peritoneal seedings
Post-operation within 3 days
Percentage of peritoneal seedings
Post-operation day 4 - 4 weeks
Percentage of peritoneal seedings
Post-operation 3 months
Percentage of peritoneal seedings
Post-operation 6 months
- +4 more secondary outcomes
Study Arms (1)
single arm, observational arm
Patients who received surgery will routinely followed up by pre-op CTC, post-op CTC until 6 months after surgery.
Eligibility Criteria
In resectable gastric cancer patients, who undergo radical intent gastrectomy surgery.
You may qualify if:
- Enrolling 150 cases
- Stage I or more advanced gastric cancer, pathology proved
- Diagnosed at age ≥ 20 years
- Enrolled before surgery at the General Surgery Department, both inpatient and outpatient services.
You may not qualify if:
- Patient's refusal
- Poor compliance, unable to cooperate for blood sampling for CTC isolation as time schedule or clinical treatment or follow-up
- Difficult blood sampling
- No more needs for CTCs evaluation, decided by clinicians.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shih-Chun Chang
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2023
First Posted
March 2, 2023
Study Start
September 1, 2021
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
March 2, 2023
Record last verified: 2023-01