Stomach NeoplasmNCT00935779
Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer
An observational study of Stomach Neoplasm, run by University of Chile at 1 site in Chile.
Trial summary
Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasm
- How many people
- 18 participants
- Where
- 1 siteChile
- Study dates
- Oct 2002to Dec 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with operable local gastric adenocarcinoma consulting to Hospital Clinico, University of Chile during study period.
Who may be able to join
- patients with operable local gastric adenocarcinoma
Who cannot join
- previous abdominal surgery
- previous open or blunt abdominal trauma
- history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity.
- All other gastric malignancies such as lymphomas, GIST, carcinoids
Trial locations and contacts
1 site in 1 country.
Chile1 site
Department of Surgery, Clinical Hospital, University of Chile
Santiago, Santiago Metropolitan
About this study
Official title: Ultra Structure of Peritoneum at Electronic Microscopy in Control Subjects and Patients With Gastric Cancer
Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.
Read the detailed description
18 out of 32 cases were eligible for analysis. Four patients operated on for benign diseases served as control and 14 patients with operable local gastric adenocarcinoma (4 mucosa/submucosa/muscular y 10 serosa lesions) were studied. At the beginning of surgery, a 2 x 2 cm. sample from macroscopically normal visceral peritoneum at mesenterium root was carefully obtained, washed with saline and fixed in glutaraldehyde solution. Besides a sample of peritoneal washing fluid was studied to exclude patients with free cancer cells. Peritoneal tissue was fixed during 24 hours and then all samples were evaluated by electronic microscope.
- Conditions
- Stomach Neoplasm
- Keywords
- Stomach Neoplasms, Peritoneum
- Medical subject headings
- Stomach Neoplasms
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 |
|---|---|---|
| Gastric cancer | patients with operable local gastric adenocarcinoma were studied | |
| Control group | patients operated on for benign diseases served as controls, randomly selected among patients with chronic gastro-esophageal reflux disease who were considered good candidates for antireflux surgery and properly matched in sex and age to study group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startOct 2002
- Primary completionJul 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Investigators
- Patricio Burdiles, MD, Principal investigator, Department of Surgery, Clinical Hospital, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935779
- Sponsor's protocol ID
- OAIC 043/02
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Structure of Peritoneum at Electronic Microscopy in Control Subjects and Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT00935779
- Acronym / sponsor ID
- OAIC 043/02
- Conditions
- Stomach Neoplasm
- Keywords
- Stomach Neoplasms, Peritoneum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Jul 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 9 Jul 2009 (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.
Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.
Detailed description
18 out of 32 cases were eligible for analysis. Four patients operated on for benign diseases served as control and 14 patients with operable local gastric adenocarcinoma (4 mucosa/submucosa/muscular y 10 serosa lesions) were studied. At the beginning of surgery, a 2 x 2 cm. sample from macroscopically normal visceral peritoneum at mesenterium root was carefully obtained, washed with saline and fixed in glutaraldehyde solution. Besides a sample of peritoneal washing fluid was studied to exclude patients with free cancer cells. Peritoneal tissue was fixed during 24 hours and then all samples were evaluated by electronic microscope.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer | – | –patients with operable local gastric adenocarcinoma were studied |
| Control group | – | –patients operated on for benign diseases served as controls, randomly selected among patients with chronic gastro-esophageal reflux disease who were considered good candidates for antireflux surgery and properly matched in sex and age to study group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with operable local gastric adenocarcinoma consulting to Hospital Clinico, University of Chile during study period.
Key inclusion criteria (1 listed)
- patients with operable local gastric adenocarcinoma
Key exclusion criteria (4 listed)
- previous abdominal surgery
- previous open or blunt abdominal trauma
- history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity.
- All other gastric malignancies such as lymphomas, GIST, carcinoids
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
Not reported in the source record.
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 9 Jul 2009.
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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.
Patricio Burdiles, MD principal investigator
Department of Surgery, Clinical Hospital, University of Chile
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 Stomach Neoplasm, run by University of Chile at 1 site in Chile.
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 1 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: finished, as of the sponsor's last update on 9 Jul 2009. 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 Chile. 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.
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 9 Jul 2009.