Oncologic PatientsNCT01438164
Cost-effectiveness of FDG-PET
An observational study of Oncologic Patients, run by University of Sao Paulo.
Trial summary
Evaluation of cost-effectiveness of FDG-PET for the public health system in Brazil. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Oncologic Patients
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Sep 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 500 oncologic patients
Who may be able to join
- Cancer
Who cannot join
- Other malignancy
- Uncontrolled Diabetes
- Pregnancy
About this study
Official title: Estudo de Custo-efetividade Para o Sistema único de Saúde - SUS Sobre o Exame de Metabolismo de Glicose Marcada Com Flúor-18 Pela Tomografia de emissão de pósitron-PET
Evaluation of cost-effectiveness of FDG-PET for the public health system in Brazil.
Read the detailed description
To provide detailed information about cost and effectiveness of FDG-PET in multiple oncological diseases, such as Lymphoma, lung cancer and esophageal cancer.
- Conditions
- Oncologic Patients
- Keywords
- FDG-PET, cancer, staging, Evaluate the cost impact in the evaluation of oncologic patients.
- Medical subject headings
- 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 |
|---|---|---|
| oncologic patients | initial staging |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startJun 2005
- Primary completionJun 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic PatientsStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Responsible party
- Principal investigator, Juliano Julio Cerci, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438164
- Sponsor's protocol ID
- USP0460/05
- Status last verified
- Sep 2011
- First submitted
- 20 Sep 2011
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudo de Custo-efetividade Para o Sistema único de Saúde - SUS Sobre o Exame de Metabolismo de Glicose Marcada Com Flúor-18 Pela Tomografia de emissão de pósitron-PET
- ClinicalTrials.gov ID
- NCT01438164
- Acronym / sponsor ID
- USP0460/05
- Conditions
- Oncologic Patients
- Keywords
- FDG-PET, cancer, staging, Evaluate the cost impact in the evaluation of oncologic patients.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- Jun 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Sep 2011 (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.
Evaluation of cost-effectiveness of FDG-PET for the public health system in Brazil.
Detailed description
To provide detailed information about cost and effectiveness of FDG-PET in multiple oncological diseases, such as Lymphoma, lung cancer and esophageal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oncologic patients | – | –initial staging |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 500 oncologic patients
Key inclusion criteria (1 listed)
- Cancer
Key exclusion criteria (3 listed)
- Other malignancy
- Uncontrolled Diabetes
- Pregnancy
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 21 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncologic Patients, run by University of Sao Paulo.
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 3 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 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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 21 Sep 2011.