Cancer of ThyroidNCT06627998
Study of the Prevalence of Osteo-metabolic Complications in Patients With Thyroid Cancer
An observational study of Cancer of Thyroid and Vertebral Fracture, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a multicenter retrospective observational study aimed to evaluate the prevalence of osteo-metabolic complications in patients with thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Thyroid, Vertebral Fracture, Osteoporosis
- What is being tested?
- Diagnostic (chest x-ray /DXA)and clinical data collected for clinical practice
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2023to Dec 2024
- 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 thyroid cancers who have been evaluated at the outpatient clinics of the Endocrinology Unit of the IRCCS San Raffaele Hospital and the Nuclear Medicine Unit of the Spedali Civili di Brescia.
Who may be able to join
- age ≥ 18 years
- Histological diagnosis of Thyroid Carcinoma
- radiological data from chest x-ray in lateral projection in the preoperative evaluation on which the vertebral morphometry
- Signing of the informed consent
Who cannot join
- Subjects not falling within the previously described criteria are excluded
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Andrea Giustina
Milan, 20132
Gabriela Felipe, nurse, 0226435062, felipe.gabriela@hsr.it
About this study
This is a multicenter retrospective observational study aimed to evaluate the prevalence of osteo-metabolic complications in patients with thyroid cancer.
Read the detailed description
Approximately 150-200 outpatients evaluated in the Endocrinology Unit of the IRCCS San Raffaele Hospital and the Nuclear Medicine Unit of the Spedali Civili of Brescia will be included in the study.
During the follow-up visits, patients who meet the inclusion criteria will be offered inclusion in the study. After signing the informed consent, the patient's anamnestic and clinical (biochemical, radiological, anamnestic) data will be retrospectively collected in an electronic database. Sensitive data will be anonymized.
- Conditions
- Cancer of Thyroid, Vertebral Fracture, Osteoporosis
- Being tested
- Diagnostic (chest x-ray /DXA)and clinical data collected for clinical practice
- Medical subject headings
- Thyroid Neoplasms, Spinal Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic (chest x-ray /DXA)and clinical data collected for clinical practiceDiagnostic test
Biochemical, clinical and radiological data performed for clinical practice will be retrospectively collected. Osteoporosis and vertebral fractures will be diagnosed through DXA scan and vertebral morphometry.
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the incidence and prevalence of osteoporosis and vertebral fractures in Patients With Thyroid Cancer
To estimate the incidence and prevalence of osteoporosis and vertebral fractures detected through DXA scan and vertebral morphometry. The effects on bone complications of the patients' clinical and biochemical characteristics will be investigated.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start12 Apr 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ThyroidStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Responsible party
- Principal investigator, Andrea Giustina, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627998
- Sponsor's protocol ID
- OsteoTIR
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Osteo-metabolic Complications in Patients With Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06627998
- Acronym / sponsor ID
- OsteoTIR
- Conditions
- Cancer of Thyroid, Vertebral Fracture, Osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Oct 2024 (actual)
- 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.
This is a multicenter retrospective observational study aimed to evaluate the prevalence of osteo-metabolic complications in patients with thyroid cancer.
Detailed description
Approximately 150-200 outpatients evaluated in the Endocrinology Unit of the IRCCS San Raffaele Hospital and the Nuclear Medicine Unit of the Spedali Civili of Brescia will be included in the study.
During the follow-up visits, patients who meet the inclusion criteria will be offered inclusion in the study. After signing the informed consent, the patient's anamnestic and clinical (biochemical, radiological, anamnestic) data will be retrospectively collected in an electronic database. Sensitive data will be anonymized.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thyroid cancers who have been evaluated at the outpatient clinics of the Endocrinology Unit of the IRCCS San Raffaele Hospital and the Nuclear Medicine Unit of the Spedali Civili di Brescia.
Key inclusion criteria (4 listed)
- age ≥ 18 years
- Histological diagnosis of Thyroid Carcinoma
- radiological data from chest x-ray in lateral projection in the preoperative evaluation on which the vertebral morphometry
- Signing of the informed consent
Key exclusion criteria (1 listed)
- Subjects not falling within the previously described criteria are excluded
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 |
|---|---|---|
| Diagnostic (chest x-ray /DXA)and clinical data collected for clinical practiceBiochemical, clinical and radiological data performed for clinical practice will be retrospectively collected. Osteoporosis and vertebral fractures will be diagnosed through DXA scan and vertebral morphometry. | Diagnostic test | – |
Primary outcome
To estimate the incidence and prevalence of osteoporosis and vertebral fractures in Patients With Thyroid Cancer
Time frame: 1 year
To estimate the incidence and prevalence of osteoporosis and vertebral fractures detected through DXA scan and vertebral morphometry. The effects on bone complications of the patients' clinical and biochemical characteristics will be investigated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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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.
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 Cancer of Thyroid and Vertebral Fracture, run by IRCCS San Raffaele at 1 site 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 4 inclusion and 1 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 4 Oct 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Di Filippo, medical doctor (0226435062, difilippo.luigi@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the incidence and prevalence of osteoporosis and vertebral fractures in Patients With Thyroid Cancer (time frame: 1 year). 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 4 Oct 2024.