Primary Liver CancerNCT00408122
Evaluation of Preoperative Investigations in Patients With Liver Cancer
An observational study of Primary Liver Cancer and Liver Metastasis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to evaluate the diagnostic procedures emission tomography in combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative evaluation of resectability of patients with primary or secondary liver cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Liver Cancer, Liver Metastasis
- What is being tested?
- PET/CT scan and EUS
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Jan 2012
- 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 liver tumors
Who may be able to join
- all patients who are referred to The Department of Surgery, Odense University Hospital, for surgical treatment of suspected or biopsy proven primary or secondary liver cancer.
Who cannot join
- age less than 18 years
- patients who are not fit for liver surgery because of co-morbidity
- patients for whom the extra investigations in the study are considered to give an increased risk because of co-morbidity such as
- Patients with s-creatinin > 150 micromol/l
- Patients who take peroral antidiabetic drugs or have a poorly regulated diabetes mellitus
- patients who do not understand the patient information
- patients who do not want to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Positron Emission Tomography/ CT Scan, Endoscopic Ultrasono¬Graphy, and Laparoscopic Ultrasonography in the Preoperative Assess¬Ment of Resectability in Patients With Primary and Secondary Liver Cancer
The aim of the study is to evaluate the diagnostic procedures emission tomography in combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative evaluation of resectability of patients with primary or secondary liver cancers.
- Conditions
- Primary Liver Cancer, Liver Metastasis
- Being tested
- PET/CT scan and EUS
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT scan and EUSProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies 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
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Patrick Ainsworth, Odense University Hospital
- Investigators
- Henning O Nielsen, MD, DMsc, Principal investigator, dept. of Surgery, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408122
- Sponsor's protocol ID
- VF-20060109
- Status last verified
- Oct 2014
- First submitted
- 5 Dec 2006
- Last updated
- 16 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Positron Emission Tomography/ CT Scan, Endoscopic Ultrasono¬Graphy, and Laparoscopic Ultrasonography in the Preoperative Assess¬Ment of Resectability in Patients With Primary and Secondary Liver Cancer
- ClinicalTrials.gov ID
- NCT00408122
- Acronym / sponsor ID
- VF-20060109
- Conditions
- Primary Liver Cancer, Liver Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Dec 2006 (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.
The aim of the study is to evaluate the diagnostic procedures emission tomography in combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative evaluation of resectability of patients with primary or secondary liver cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAtients with liver tumors
Key inclusion criteria (1 listed)
- all patients who are referred to The Department of Surgery, Odense University Hospital, for surgical treatment of suspected or biopsy proven primary or secondary liver cancer.
Key exclusion criteria (7 listed)
- age less than 18 years
- patients who are not fit for liver surgery because of co-morbidity
- patients for whom the extra investigations in the study are considered to give an increased risk because of co-morbidity such as
- patients who do not understand the patient information
- patients who do not want to participate
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 |
|---|---|---|
| PET/CT scan and EUS | Procedure or surgery | – |
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 16 Oct 2014.
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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.
Henning O Nielsen, MD, DMsc principal investigator
dept. of Surgery, Odense University 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 Primary Liver Cancer and Liver Metastasis, run by Odense University Hospital at 1 site in Denmark.
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 7 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 16 Oct 2014. 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 Denmark. 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 16 Oct 2014.