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Trial Title:
The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
NCT ID:
NCT05752357
Condition:
Carcinoma
Conditions: Official terms:
Stomach Neoplasms
Neoplastic Cells, Circulating
Conditions: Keywords:
Circulating tumor cells
gastric cancer
peritoneal carcinomatosis
recurrence
metastasis
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Detailed description:
Circulating tumor cells (CTCs) are an emerging "liquid biopsy" that provide prognostic
value for various types of solid cancer on early recurrence and survival. The evaluation
of CTCs might be a useful strategy to predict tumor progression and prognosis in Gastric
adenocarcinoma (GC). Previous study has shown that the frequency of CTC detection was
higher in advanced GC than early GC, in poorly differentiated GC than well/moderately
differentiated GC, and in GC with lymphatic metastasis than that without lymphatic
metastasis. However, the impact of CTCs in the detection of PM in GC is still under
debate. Peritoneal metastasis (PM) is highly related to recurrence and metastasis in GC;
therefore, it was significantly related to disease free and overall survival of
participants.
Consequently, several important questions and goals will be answered by this study:
To elucidate the clinical relationship between CTCs and PM in GCs before the operation;
therefore, it could be an indicator of prophylactic during operation, which may possibly
prolong the disease free and overall survival.
To establish a good model to follow-up a specific surface marker on CTCs, which could be
possibly utilized as a more sensitive marker, comparing with CEA or image study, to more
accurately detect the early recurrence or metastasis in GC.
To verify that dynamically monitoring CTCs status and changes during long-term follow-up
and anti-cancer treatment are feasible and clinically meaningful to survival or treatment
responses.
Criteria for eligibility:
Study pop:
In resectable gastric cancer patients, who undergo radical intent gastrectomy surgery.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chang Gung Memorial Hospital
Address:
City:
Taoyuan City
Zip:
333
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Shih-Chun Chang
Phone:
+886 975361360
Email:
b9302071@cgmh.org.tw
Start date:
September 1, 2021
Completion date:
August 31, 2024
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05752357
