Gastric AdenocarcinomaNCT02801955
Serum and Peritoneal CEA and CA 19-9 for Gastric Adenocarcinoma
An observational study of Gastric Adenocarcinoma, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
For preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 may be helpful. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- gastrectomy and sampling of peritoneal washing aspirate
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2015to Mar 2017
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: gastric adenocarcinoma treated with curative gastrectomy
Who may be able to join
- Endoscopically proven gastric adenocarcinoma
- Standard gastrectomy and a D2 lymph node dissection;
- Desire to attend the study protocol
Who cannot join
- Metastatic or overt peritoneal disseminated cancer
- Undesired reaction to attend the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of Serum and Peritoneal CEA and CA 19-9 for TNM Stage and Peritoneal Dissemination of Gastric Adenocarcinoma
For preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 may be helpful. Additionally, the prognosis of the patients with gastric adenocarcinoma treated with gastrectrectomy may be associated with serum and peritoneal levels of tumor markers.
Read the detailed description
Clinical usage of tumor markers on preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma is a controversial issue. It has been thought that there is a positive correlation between serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 and pathologic features of gastric tumors and peritoneal dissemination.
In this study, it was aimed to evaluate the effect of serum and peritoneal CEA and CA 19-9 to predict TNM stages and peritoneal washing cytology in patients with gastric adenocarcinoma after curative gastrectomy, and to determine predictive value of these measurements to the development of recurrence and death.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- gastrectomy, sampling of peritoneal washing aspirate
- Keywords
- gastric adenocarcinoma, tumor markers, peritoneal cytology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrectomyProcedure or surgery
radical total/subtotal gastrectomy with D2 lymph node dissection
sampling of peritoneal washing aspirateProcedure or surgery
After thoroughly examination of the peritoneal cavity revealing the absence of peritoneal dissemination, the peritoneal cavity was washed with 200 ml of saline, and at least one third was aspirated from several regions of the peritoneal cavity, including near the primary tumor, the left and right subphrenic areas and the pouch of Douglas with suction tubes to a clean bottle and designated as the peritoneal sample for determination of peritoneal levels of CEA and CA 19-9.
| Study group | Role | What they receive |
|---|---|---|
| tumor marker | serum CEA and CA 19-9 levels in patients with curative gastrectomy preoperatively and peritoneal CEA and CA 19-9 levels in patients taken at the beginning of curative gastrectomy via sampling of peritoneal washing aspirate Receives: Procedure: gastrectomy; Procedure: sampling of peritoneal washing aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNM stage
TNM stage based on the 7th American Joint Committee on Cancer/International Union Against Cancer tumor, node, metastasis system.
Measured: through pathologic report completion, an average of 1 month
Secondary outcomes (2)
peritoneal washing cytology
detection of positive free peritoneal gastric adenocarcinoma cells.
Measured: through pathologic report completion, an average of 1 month
recurrence/death
detection of recurrence or development of death
Measured: through follow-up period, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startApr 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Hasbahceci, Bezmialem Vakif University
- Investigators
- mustafa hasbahceci, assoc. prof., Principal investigator, bezmialem vakif university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801955
- Sponsor's protocol ID
- GastCancTmMark2016
- Status last verified
- Jun 2017
- First submitted
- 3 Jun 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Serum and Peritoneal CEA and CA 19-9 for TNM Stage and Peritoneal Dissemination of Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02801955
- Acronym / sponsor ID
- GastCancTmMark2016
- Conditions
- Gastric Adenocarcinoma
- Keywords
- gastric adenocarcinoma, tumor markers, peritoneal cytology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Jun 2016 (estimated)
- 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.
For preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 may be helpful. Additionally, the prognosis of the patients with gastric adenocarcinoma treated with gastrectrectomy may be associated with serum and peritoneal levels of tumor markers.
Detailed description
Clinical usage of tumor markers on preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma is a controversial issue. It has been thought that there is a positive correlation between serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 and pathologic features of gastric tumors and peritoneal dissemination.
In this study, it was aimed to evaluate the effect of serum and peritoneal CEA and CA 19-9 to predict TNM stages and peritoneal washing cytology in patients with gastric adenocarcinoma after curative gastrectomy, and to determine predictive value of these measurements to the development of recurrence and death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tumor marker | – | Procedure: gastrectomy, Procedure: sampling of peritoneal washing aspirateserum CEA and CA 19-9 levels in patients with curative gastrectomy preoperatively and peritoneal CEA and CA 19-9 levels in patients taken at the beginning of curative gastrectomy via sampling of peritoneal washing aspirate |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- gastric adenocarcinoma treated with curative gastrectomy
Key inclusion criteria (3 listed)
- Endoscopically proven gastric adenocarcinoma
- Standard gastrectomy and a D2 lymph node dissection;
- Desire to attend the study protocol
Key exclusion criteria (2 listed)
- Metastatic or overt peritoneal disseminated cancer
- Undesired reaction to attend the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastrectomyradical total/subtotal gastrectomy with D2 lymph node dissection | Procedure or surgery | tumor marker |
| sampling of peritoneal washing aspirateAfter thoroughly examination of the peritoneal cavity revealing the absence of peritoneal dissemination, the peritoneal cavity was washed with 200 ml of saline, and at least one third was aspirated from several regions of the peritoneal cavity, including near the primary tumor, the left and right subphrenic areas and the pouch of Douglas with suction tubes to a clean bottle and designated as the peritoneal sample for determination of peritoneal levels of CEA and CA 19-9. | Procedure or surgery | tumor marker |
Primary outcome
TNM stage
Time frame: through pathologic report completion, an average of 1 month
TNM stage based on the 7th American Joint Committee on Cancer/International Union Against Cancer tumor, node, metastasis system.
2 secondary outcomes
peritoneal washing cytology
Time frame: through pathologic report completion, an average of 1 month
recurrence/death
Time frame: through follow-up period, an average of 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: No
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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.
mustafa hasbahceci, assoc. prof. principal investigator
bezmialem vakif university faculty of medicine
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 Gastric Adenocarcinoma, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jun 2017. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNM stage (time frame: through pathologic report completion, an average of 1 month). 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 14 Jun 2017.