CarcinomaNCT05752357
The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
An observational study of Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2021to 31 Aug 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In resectable gastric cancer patients, who undergo radical intent gastrectomy surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan City, 333
Shih-Chun Chang, +886 975361360, b9302071@cgmh.org.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Carcinoma
- Keywords
- Circulating tumor cells, gastric cancer, peritoneal carcinomatosis, recurrence, metastasis
- Medical subject headings
- Carcinoma, Neoplastic Cells, Circulating, Stomach Neoplasms, Peritoneal Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Post-operation within 3 days
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.
Measured: Post-operation day 4 - 4 weeks
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.
Measured: Post-operation 3 months
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.
Measured: Post-operation 6 months
Secondary outcomes (9)
Percentage of peritoneal seedings
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
Measured: Baseline
Percentage of peritoneal seedings
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
Measured: Post-operation within 3 days
Percentage of peritoneal seedings
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
Measured: Post-operation day 4 - 4 weeks
Percentage of peritoneal seedings
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
Measured: Post-operation 3 months
Percentage of peritoneal seedings
Circulating tumor cells detection in different time after operation, to early detect peritoneal carcinomatosis or occult metastasis.
Measured: Post-operation 6 months
overall survival time
To correlate the relationship of circulating tumor cells and long-term survival time.
Measured: Post-operation 1 year.
overall survival time
To correlate the relationship of circulating tumor cells and long-term survival time.
Measured: Post-operation 2 year.
Progression-free survival
To correlate the relationship of circulating tumor cells and Progression-free survival.
Measured: Post-operation 1 year.
Progression-free survival
To correlate the relationship of circulating tumor cells and Progression-free survival.
Measured: Post-operation 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Sep 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shih-Chun Chang, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752357
- Sponsor's protocol ID
- 202100832B0
- Status last verified
- Jan 2023
- First submitted
- 8 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Circulating Tumor Cells Provide Diagnostic and Prognostic Roles in Peritoneal Carcinomatosis, Recurrence and Metastasis in Gastric Cancer, Pre-operatively and Postoperatively?
- ClinicalTrials.gov ID
- NCT05752357
- Acronym / sponsor ID
- 202100832B0
- Conditions
- Carcinoma
- Keywords
- Circulating tumor cells, gastric cancer, peritoneal carcinomatosis, recurrence, metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm, observational arm | – | –Patients who received surgery will routinely followed up by pre-op CTC, post-op CTC until 6 months after surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In resectable gastric cancer patients, who undergo radical intent gastrectomy surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
9 secondary outcomes
Percentage of peritoneal seedings
Time frame: Baseline
Percentage of peritoneal seedings
Time frame: Post-operation within 3 days
Percentage of peritoneal seedings
Time frame: Post-operation day 4 - 4 weeks
Percentage of peritoneal seedings
Time frame: Post-operation 3 months
Percentage of peritoneal seedings
Time frame: Post-operation 6 months
overall survival time
Time frame: Post-operation 1 year.
overall survival time
Time frame: Post-operation 2 year.
Progression-free survival
Time frame: Post-operation 1 year.
Progression-free survival
Time frame: Post-operation 2 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Chun Chang principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Chun Chang (+886 975361360, b9302071@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of disease recurrence (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.