Pancreatic Tubular AdenocarcinomaGEMSTHERNCT00947102
Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Cancer
An observational study of Pancreatic Tubular Adenocarcinoma, run by Blood Transfusion Centre of Slovenia at 1 site in Slovenia.
Trial summary
Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Pancreatic Tubular Adenocarcinoma
- What is being tested?
- Observation
- How many people
- Not given
- Where
- 1 siteSlovenia
- Study dates
- Feb 2009to Dec 2011
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after resection of pancreatic tubular adenocarcinoma
Who may be able to join
- ECOG performance status 0-2 at the time of inclusion
- Following R0 or R1 pancreatic tubular adenocarcinoma resection
Who cannot join
- Pregnancy
- Serious comorbidity
Trial locations and contacts
1 site in 1 country.
Lojze Smid, MD contact
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana; Department for Gastroenterology
Ljubljana, Ljubljana, 1000
Borut Stabuc, MD, PhD, +386 1 522 2210, borut.stabuc@kclj.si
Lojze Smid, MD, lojze.smid.jr@mf.uni-lj.si
About this study
Official title: Observational Study - Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Tubular Carcinoma
Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection.
- Conditions
- Pancreatic Tubular Adenocarcinoma
- Being tested
- Observation
- Keywords
- pancreatic tubular adenocarcinoma, gemcitabine, gene expression, immunological status, serological status, pancreatic tubular adenocarcinoma adjuvant setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic tubular adenocarcinoma | Patients with pancreatic tubular adenocarcinoma Receives: Other: Observation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Tubular AdenocarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Blood Transfusion Centre of Slovenia
- Sponsor type
- Other government
- Collaborators
- University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947102
- Sponsor's protocol ID
- Gemcitabine1
- Acronym
- GEMSTHER
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study - Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Tubular Carcinoma
- ClinicalTrials.gov ID
- NCT00947102
- Acronym / sponsor ID
- GEMSTHER / Gemcitabine1
- Conditions
- Pancreatic Tubular Adenocarcinoma
- Keywords
- pancreatic tubular adenocarcinoma, gemcitabine, gene expression, immunological status, serological status, pancreatic tubular adenocarcinoma adjuvant setting
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Blood Transfusion Centre of SloveniaOther government
- Collaborators
- University Medical Centre Ljubljana
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 27 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.
Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic tubular adenocarcinoma | – | Other: ObservationPatients with pancreatic tubular adenocarcinoma |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after resection of pancreatic tubular adenocarcinoma
Key inclusion criteria (2 listed)
- ECOG performance status 0-2 at the time of inclusion
- Following R0 or R1 pancreatic tubular adenocarcinoma resection
Key exclusion criteria (2 listed)
- Pregnancy
- Serious comorbidity
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 |
|---|---|---|
| Observation | Other | Pancreatic tubular adenocarcinoma |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
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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.
Lojze Smid, MD contact
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 Pancreatic Tubular Adenocarcinoma, run by Blood Transfusion Centre of Slovenia at 1 site in Slovenia.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Jan 2010. 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 Slovenia. 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 Borut Stabuc, MD, PhD (+386 1 522 22 10, borut.stabuc@kclj.si), or a site near the patient. 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 13 Jan 2010.