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

February 21, 2023 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In resectable gastric cancer patients, who undergo radical intent gastrectomy surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
single arm, observational arm
Patients who received surgery will routinely followed up by pre-op CTC, post-op CTC until 6 months after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of disease recurrence
Time Frame: Baseline
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
Time Frame: Post-operation within 3 days
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
Time Frame: Post-operation day 4 - 4 weeks
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
Time Frame: Post-operation 3 months
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
Time Frame: Post-operation 6 months
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Shih-Chun Chang, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

August 31, 2024

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202100832B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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