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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?

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05752357
Enrollment
150
Registered
2023-03-02
Start date
2021-09-01
Completion date
2024-08-31
Last updated
2023-03-02

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

Conditions

Carcinoma

Keywords

Circulating tumor cells, gastric cancer, peritoneal carcinomatosis, recurrence, metastasis

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of disease recurrenceBaselineCirculating tumor cells detection in different time after operation, to evaluate the clinical relationship between Circulating tumor cells and disease recurrence.

Secondary

MeasureTime frameDescription
Percentage of peritoneal seedingsBaselineCirculating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
overall survival timePost-operation 1 year.To correlate the relationship of circulating tumor cells and long-term survival time.
Progression-free survivalPost-operation 1 year.To correlate the relationship of circulating tumor cells and Progression-free survival.

Countries

Taiwan

Contacts

Primary ContactShih-Chun Chang
b9302071@cgmh.org.tw+886 975361360
Backup ContactChia-Hsun Hsieh
wisdom5000@gmail.com+886 975366137

Outcome results

None listed

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