The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.

Carcinoma Clinical Trial

Official title:

Does Circulating Tumor Cells Provide Diagnostic and Prognostic Roles in Peritoneal Carcinomatosis, Recurrence and Metastasis in Gastric Cancer, Pre-operatively and Postoperatively?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752357
• Other study ID #: 202100832B0
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2023
• Source: Chang Gung Memorial Hospital
• Contact: Shih-Chun Chang
• Phone: +886 975361360
• Email: b9302071[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Neoplastic Cells, Circulating
• Stomach Neoplasms

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of peritoneal seedings	Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.	Baseline
Secondary	Percentage of peritoneal seedings	Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.	Post-operation within 3 days
Secondary	Percentage of peritoneal seedings	Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.	Post-operation day 4 - 4 weeks
Secondary	Percentage of peritoneal seedings	Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.	Post-operation 3 months
Secondary	Percentage of peritoneal seedings	Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.	Post-operation 6 months
Secondary	overall survival time	To correlate the relationship of circulating tumor cells and long-term survival time.	Post-operation 1 year.
Secondary	overall survival time	To correlate the relationship of circulating tumor cells and long-term survival time.	Post-operation 2 year.
Secondary	Progression-free survival	To correlate the relationship of circulating tumor cells and Progression-free survival.	Post-operation 1 year.
Secondary	Progression-free survival	To correlate the relationship of circulating tumor cells and Progression-free survival.	Post-operation 2 year.