Thyroid CancerNCT04274829
Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid
An observational study of Thyroid Cancer and Lymph Node Metastases, run by University of Cagliari at 1 site in Italy.
Trial summary
Papillary thyroid microcarcinoma (PTMC), defined as a tumor with larger diameter ≤ 1 cm, is considered a tumor with an indolent course and an excellent prognosis. Nevertheless, the incidence of lymph node metastasis in PTMC is not negligible, reaching up to 65% in some series. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer, Lymph Node Metastases
- What is being tested?
- Thyroidecomt and lymphectomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with papillary thyroid carcinoma
Who may be able to join
- Patients with papillary microcarcinoma of the thyroid
Who cannot join
- Patients with thyroid nodules > 1 cm; incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Papillary thyroid microcarcinoma (PTMC), defined as a tumor with larger diameter ≤ 1 cm, is considered a tumor with an indolent course and an excellent prognosis. Nevertheless, the incidence of lymph node metastasis in PTMC is not negligible, reaching up to 65% in some series. The aim of this study was to assess the incidence of lymph node metastasis in patients with PTMC and to evaluate predictive factors for lymph node metastasis.
- Conditions
- Thyroid Cancer, Lymph Node Metastases
- Being tested
- Thyroidecomt and lymphectomy
- Medical subject headings
- Thyroid Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroidecomt and lymphectomyProcedure or surgery
Patients underwent total thyroidectomy or lobectomy associated to lymph node sampling or neck lymphectomy
| Study group | Role | What they receive |
|---|---|---|
| PTMC | Patients with papillary microcarcinoma of the thyroid Receives: Procedure: Thyroidecomt and lymphectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of lymph node metastasis
To define the incidence of lymph node metastasis in patients with papillary microcarcinoma
Measured: 1 year
Secondary outcomes (1)
Predicrive factors of lymph node metastasis
To assesss predictive factors of lymph node metastasis
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 posted18 Feb 2020
- Study startJan 2010
- Primary completionJan 2018
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Medas, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274829
- Sponsor's protocol ID
- MICRO-PTC-LN
- Status last verified
- Feb 2020
- First submitted
- 15 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Medas F, Canu GL, Cappellacci F, Boi F, Lai ML, Erdas E, Calo PG. Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid: Retrospective Analysis on 293 Cases. Front Endocrinol (Lausanne). 2020 Aug 25;11:551. doi: 10.3389/fendo.2020.00551. eCollection 2020.
PubMed 32982963
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid
- ClinicalTrials.gov ID
- NCT04274829
- Acronym / sponsor ID
- MICRO-PTC-LN
- Conditions
- Thyroid Cancer, Lymph Node Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 18 Feb 2020 (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.
Papillary thyroid microcarcinoma (PTMC), defined as a tumor with larger diameter ≤ 1 cm, is considered a tumor with an indolent course and an excellent prognosis. Nevertheless, the incidence of lymph node metastasis in PTMC is not negligible, reaching up to 65% in some series. The aim of this study was to assess the incidence of lymph node metastasis in patients with PTMC and to evaluate predictive factors for lymph node metastasis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTMC | – | Procedure: Thyroidecomt and lymphectomyPatients with papillary microcarcinoma of the thyroid |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with papillary thyroid carcinoma
Key inclusion criteria (1 listed)
- Patients with papillary microcarcinoma of the thyroid
Key exclusion criteria (1 listed)
- Patients with thyroid nodules > 1 cm; incomplete data
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 |
|---|---|---|
| Thyroidecomt and lymphectomyPatients underwent total thyroidectomy or lobectomy associated to lymph node sampling or neck lymphectomy | Procedure or surgery | PTMC |
Primary outcome
Incidence of lymph node metastasis
Time frame: 1 year
To define the incidence of lymph node metastasis in patients with papillary microcarcinoma
1 secondary outcome
Predicrive factors of lymph node metastasis
Time frame: 1 year
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 18 Feb 2020.
- Derived from this study: PubMed 32982963Medas F, Canu GL, Cappellacci F, Boi F, Lai ML, Erdas E, Calo PG. Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid: Retrospective Analysis on 293 Cases. Front Endocrinol (Lausanne). 2020 Aug 25;11:551. doi: 10.3389/fendo.2020.00551. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Thyroid Cancer and Lymph Node Metastases, run by University of Cagliari 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 1 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: finished, as of the sponsor's last update on 18 Feb 2020. 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?
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?
Incidence of lymph node metastasis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04274829, which also lists 1 linked publication.
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 18 Feb 2020.