Thyroid CancerTIR-2009-01NCT01074684
Predictive Factors of Clinical, Laboratory and Imaging Findings Routinely Used in Diagnosing Thyroid Cancer
An observational study of Thyroid Cancer, run by National Cancer Institute, Naples at 8 sites in Italy.
Trial summary
The purpose of this study is to describe the correlation between the cytohistology exam of patients undergoing thyroid surgery, and the predictive values of: suspicious clinical findings, preoperative thyroid imaging, and the incidence of thyroid cancer in cytologically negative nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- How many people
- 959 participants
- Where
- 8 sitesItaly
- Study dates
- Jan 2010to 1 Dec 2021
- 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: Consecutive patients with palpable thyroid nodules with indication for surgery (positive cytology, 2 consecutive inconclusive cytologies, or negative cytology with at least 2 of the following: previous exposure to neck radiation, calcitonin greater than twice normal values, positive pentagastrin test, or irregular margins or hypoechogenicity on ultrasound.
Who may be able to join
- Consecutive patients presenting for thyroid disease (palpable nodules)
- Indication for surgery
- Age > 18 years
- Signed informed consent for surgery
- Signed informed consent for data collection
Who cannot join
- Concurrent condition that contraindicates surgery
- Clinical or radiologic evidence of locally advanced tumor
- Clinical or radiologic evidence of metastatic lymph nodes or distant metastases
- Nonpalpable nodes
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Università di Cagliari
Cagliari
Azienda Ospedaliera Unviersitaria Careggi - Firenze
Florence
ASL TO/4 Ospedale di Ivrea
Ivrea
Istituto Nazionale dei Tumori
Naples
Azienda Ospedaliera Universitaria di Padova
Padova
Università Cattolica del Sacro Cuore di Roma Policlinico Gemelli
Roma
Ospedale di Taormina
Taormina
Università degli studi di Perugia - Sede di Terni
Terni
About this study
Official title: Defining Predictive Factors of Clinical, Laboratory and Imaging Criteria Routinely Used in the Diagnosis of Thyroid Cancer: Observational, Prospective Multicentered Study
The purpose of this study is to describe the correlation between the cytohistology exam of patients undergoing thyroid surgery, and the predictive values of: suspicious clinical findings, preoperative thyroid imaging, and the incidence of thyroid cancer in cytologically negative nodes.
- Conditions
- Thyroid Cancer
- Keywords
- diagnosis, nodules, fine needle aspiration
- Medical subject headings
- Thyroid Neoplasms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
positive predictive value of preoperative suspicious clinical, laboratory and imaging findings
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startJan 2010
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid 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
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciano Pezzulo, M.D., Principal investigator, National Cancer Institute, NaplesMaria Grazia Chiofalo, M.D., Principal investigator, National Cancer Institute, NaplesMassimo Di Maio, M.D., Principal investigator, National Cancer Institute, NaplesFrancesco Perrone, M.D., Ph.D., Principal investigator, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074684
- Sponsor's protocol ID
- TIR-2009-01
- Acronym
- TIR-2009-01
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2010
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Predictive Factors of Clinical, Laboratory and Imaging Criteria Routinely Used in the Diagnosis of Thyroid Cancer: Observational, Prospective Multicentered Study
- ClinicalTrials.gov ID
- NCT01074684
- Acronym / sponsor ID
- TIR-2009-01 / TIR-2009-01
- Conditions
- Thyroid Cancer
- Keywords
- diagnosis, nodules, fine needle aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Feb 2010 (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 purpose of this study is to describe the correlation between the cytohistology exam of patients undergoing thyroid surgery, and the predictive values of: suspicious clinical findings, preoperative thyroid imaging, and the incidence of thyroid cancer in cytologically negative nodes.
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
- Consecutive patients with palpable thyroid nodules with indication for surgery (positive cytology, 2 consecutive inconclusive cytologies, or negative cytology with at least 2 of the following: previous exposure to neck radiation, calcitonin greater than twice normal values, positive pentagastrin test, or irregular margins or hypoechogenicity on ultrasound.
Key inclusion criteria (5 listed)
- Consecutive patients presenting for thyroid disease (palpable nodules)
- Indication for surgery
- Age > 18 years
- Signed informed consent for surgery
- Signed informed consent for data collection
Key exclusion criteria (4 listed)
- Concurrent condition that contraindicates surgery
- Clinical or radiologic evidence of locally advanced tumor
- Clinical or radiologic evidence of metastatic lymph nodes or distant metastases
- Nonpalpable nodes
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
positive predictive value of preoperative suspicious clinical, laboratory and imaging findings
Time frame: at baseline
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 24 Mar 2023.
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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.
Luciano Pezzulo, M.D. principal investigator
National Cancer Institute, Naples
Maria Grazia Chiofalo, M.D. principal investigator
National Cancer Institute, Naples
Massimo Di Maio, M.D. principal investigator
National Cancer Institute, Naples
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by National Cancer Institute, Naples at 8 sites in Italy.
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 5 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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.
What does the primary outcome measure?
positive predictive value of preoperative suspicious clinical, laboratory and imaging findings (time frame: at baseline). 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 24 Mar 2023.