Parotid Gland NeoplasmsEarly Phase 1NCT00534612
Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors
A Early Phase 1 study testing aspiration biopsy in people with Parotid Gland Neoplasms, run by National Institute of Cancerología at 1 site in Mexico.
Trial summary
Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All information regarding this procedure has been retrospective. Our objective is to evaluate prospectively the diagnostic accuracy of the test, alone and when associated to clinical and/or radiologic data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Gland Neoplasms
- What is being tested?
- aspiration biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2003to Dec 2007
- Phase
- Early Phase 1
- 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
Who may be able to join
- Consecutive patients with parotid gland masses
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Cancer Institute
México, D.F:, 14080
Jose F Carrillo, M.D.
About this study
Official title: Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With Parotid Gland Masses
Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All information regarding this procedure has been retrospective. Our objective is to evaluate prospectively the diagnostic accuracy of the test, alone and when associated to clinical and/or radiologic data.
Read the detailed description
This is a prospective diagnostic test study. Inclusion criteria are all consecutive patients with parotid gland masses referred for treatment at our center, from January 2003 to December 2007.
The gold standard for the diagnosis of malignancy is the surgical pathology report of the parotidectomy specimen.
Cytologist and pathologist will be blind. Diagnostic accuracy is determinded by Bayesian analysis.
- Conditions
- Parotid Gland Neoplasms
- Being tested
- aspiration biopsy
- Keywords
- Parotid gland neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspiration biopsyProcedure or surgery
fine needle aspiration biopsy of the parotid gland masses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fine needle aspiration biopsy of the parotid gland mass Receives: Procedure: aspiration biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of malignancy
Measured: three years
Secondary outcomes (1)
Specific histopathologic diagnosis
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJan 2003
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid Gland NeoplasmsStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Investigators
- Jose F Carrillo, M.D:, Principal investigator, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534612
- Sponsor's protocol ID
- 006/038/CCI
- Status last verified
- Jan 2003
- First submitted
- 21 Sep 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With Parotid Gland Masses
- ClinicalTrials.gov ID
- NCT00534612
- Acronym / sponsor ID
- 006/038/CCI
- Conditions
- Parotid Gland Neoplasms
- Keywords
- Parotid gland neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Institute of CancerologíaOther government
- Study start
- Jan 2003
- Study completion
- Dec 2007 (estimated)
- First posted
- 26 Sep 2007 (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.
Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All information regarding this procedure has been retrospective. Our objective is to evaluate prospectively the diagnostic accuracy of the test, alone and when associated to clinical and/or radiologic data.
Detailed description
This is a prospective diagnostic test study. Inclusion criteria are all consecutive patients with parotid gland masses referred for treatment at our center, from January 2003 to December 2007.
The gold standard for the diagnosis of malignancy is the surgical pathology report of the parotidectomy specimen.
Cytologist and pathologist will be blind. Diagnostic accuracy is determinded by Bayesian analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: aspiration biopsyfine needle aspiration biopsy of the parotid gland mass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients with parotid gland masses
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| aspiration biopsyfine needle aspiration biopsy of the parotid gland masses | Procedure or surgery | 1 |
Primary outcome
Diagnosis of malignancy
Time frame: three years
1 secondary outcome
Specific histopathologic diagnosis
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2007.
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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.
Jose F Carrillo, M.D: principal investigator
Instituto Nacional de Cancerologia de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing aspiration biopsy in people with Parotid Gland Neoplasms, run by National Institute of Cancerología at 1 site in Mexico.
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 0 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 26 Sep 2007. 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 Mexico. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jose F Carrillo, M.D. (+52 (55) 56280400 ext. 284, josecar@prodigy.net.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of malignancy (time frame: three years). 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 26 Sep 2007.