Clinical trial NCT05752357: The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
Official title: Does Circulating Tumor Cells Provide Diagnostic and Prognostic Roles in Peritoneal Carcinomatosis, Recurrence and Metastasis in Gastric Cancer, Pre-operatively and Postoperatively?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma
Keywords: Circulating tumor cells
gastric cancer
peritoneal carcinomatosis
recurrence
metastasis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In resectable gastric cancer patients, who undergo radical intent gastrectomy surgery.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of disease recurrence
timeFrame: Baseline
measure: Percentage of disease recurrence
timeFrame: Post-operation within 3 days
measure: Percentage of disease recurrence
timeFrame: Post-operation day 4 - 4 weeks
measure: Percentage of disease recurrence
timeFrame: Post-operation 3 months
measure: Percentage of disease recurrence
timeFrame: Post-operation 6 months
Secondary outcomes:
measure: Percentage of peritoneal seedings
timeFrame: Baseline
measure: Percentage of peritoneal seedings
timeFrame: Post-operation within 3 days
measure: Percentage of peritoneal seedings
timeFrame: Post-operation day 4 - 4 weeks
measure: Percentage of peritoneal seedings
timeFrame: Post-operation 3 months
measure: Percentage of peritoneal seedings
timeFrame: Post-operation 6 months
measure: overall survival time
timeFrame: Post-operation 1 year.
measure: overall survival time
timeFrame: Post-operation 2 year.
measure: Progression-free survival
timeFrame: Post-operation 1 year.
measure: Progression-free survival
timeFrame: Post-operation 2 year.
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Shih-Chun Chang
role: PRINCIPAL_INVESTIGATOR
References: