Papillary Thyroid CancerNCT03889769
Evaluation of Accuracy of One-Step Nucleic Acid Amplification (OSNA) in Diagnosis of Lymph Node Metastases of Papillary Thyroid Carcinoma
An observational study of Papillary Thyroid Cancer and Lymph Node Metastases, run by University of Cagliari at 1 site in Italy.
Trial summary
The incidence of node metastases in papillary thyroid carcinoma (PTC) is high, ranging from 20% to 90%. Prophylactic central lymph node compartment dissection (CLND), suggested from the latest guidelines for high-risk tumors, meets resistance due to the high incidence of postoperative complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Papillary Thyroid Cancer, Lymph Node Metastases
- What is being tested?
- OSNA test
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2016to 30 Sep 2019
- 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 preoperative cytological diagnosis of papillary thyroid carcinoma (Tir4-Tir5)
Who may be able to join
- Preoperative diagnosis of thyroid carcinoma
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico di Monserrato
Monserrato, Cagliari, 09040
Fabio Medas, +393206836288, fabiomedas@gmail.com
About this study
The incidence of node metastases in papillary thyroid carcinoma (PTC) is high, ranging from 20% to 90%. Prophylactic central lymph node compartment dissection (CLND), suggested from the latest guidelines for high-risk tumors, meets resistance due to the high incidence of postoperative complications. Recently, new molecular biologic techniques, such as One Step Nucleic Acid Amplification (OSNA), have spread widely, allowing to quickly isolate, amplify and quantify mRNA encoding for proteins selectively present in neoplastic cells, as Cytokeratine-19. The aim of this study is to evaluate the application of OSNA to intraoperative diagnosis of node metastases of PTC.
Read the detailed description
Papillary thyroid carcinoma (PTC) is the most common malignant thyroid neoplasm; it originates from follicular cells of thyroid gland, and represents over 80% of thyroid tumors. The incidence of PTC has progressively been increasing in the last decades, doubling since the 1970s, due to the diffusion of screening ultrasound. Although PTCs are considered slow-growing tumors, the incidence of node metastases is high, ranging from 20% to 90%. The real impact of node metastases on prognosis is still a matter of debate: reports in literature demonstrate a reduction of disease-free survival but are divergent on overall survival. Diagnostic tools have poor accuracy for central lymph node compartment, which is the most frequent site of metastases.
The last guidelines suggest a prophylactic central lymph node compartment dissection (CLND) in patients with high-risk PTC; nevertheless, this indication meets resistance due to the higher incidence of postoperative complications, especially hypoparathyroidism and recurrent laryngeal nerve (RLN) palsy.
Recently, new molecular biologic techniques have spread widely, mainly in diagnosis of node metastases in breast carcinoma; these assays allow to quickly isolate, amplify and quantify mRNA encoding for proteins selectively present in neoplastic cells, as Cytokeratine-19 (CK-19). One Step Nucleic Acid Amplification (OSNA) is routinely used in diagnosis of node metastasis in sentinel lymph node (SNL) of patients affected from breast cancer. The aim of this study is to evaluate if application of OSNA to intraoperative diagnosis of node metastases of PTC is possible.
- Conditions
- Papillary Thyroid Cancer, Lymph Node Metastases
- Being tested
- OSNA test
- Medical subject headings
- Thyroid Cancer, Papillary, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSNA testDiagnostic test
Analysis of lymph node with OSNA
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of OSNA
Measurement of OSNA accuracy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start20 Dec 2016
- Primary completion1 Apr 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Medas, University of Cagliari
- Investigators
- Pietro Giorgio Calò, Principal investigator, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889769
- Sponsor's protocol ID
- NP20164594
- Status last verified
- Mar 2019
- First submitted
- 23 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of One-Step Nucleic Acid Amplification (OSNA) in Diagnosis of Lymph Node Metastases of Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT03889769
- Acronym / sponsor ID
- NP20164594
- Conditions
- Papillary Thyroid Cancer, Lymph Node Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 26 Mar 2019 (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.
The incidence of node metastases in papillary thyroid carcinoma (PTC) is high, ranging from 20% to 90%. Prophylactic central lymph node compartment dissection (CLND), suggested from the latest guidelines for high-risk tumors, meets resistance due to the high incidence of postoperative complications. Recently, new molecular biologic techniques, such as One Step Nucleic Acid Amplification (OSNA), have spread widely, allowing to quickly isolate, amplify and quantify mRNA encoding for proteins selectively present in neoplastic cells, as Cytokeratine-19. The aim of this study is to evaluate the application of OSNA to intraoperative diagnosis of node metastases of PTC.
Detailed description
Papillary thyroid carcinoma (PTC) is the most common malignant thyroid neoplasm; it originates from follicular cells of thyroid gland, and represents over 80% of thyroid tumors. The incidence of PTC has progressively been increasing in the last decades, doubling since the 1970s, due to the diffusion of screening ultrasound. Although PTCs are considered slow-growing tumors, the incidence of node metastases is high, ranging from 20% to 90%. The real impact of node metastases on prognosis is still a matter of debate: reports in literature demonstrate a reduction of disease-free survival but are divergent on overall survival. Diagnostic tools have poor accuracy for central lymph node compartment, which is the most frequent site of metastases.
The last guidelines suggest a prophylactic central lymph node compartment dissection (CLND) in patients with high-risk PTC; nevertheless, this indication meets resistance due to the higher incidence of postoperative complications, especially hypoparathyroidism and recurrent laryngeal nerve (RLN) palsy.
Recently, new molecular biologic techniques have spread widely, mainly in diagnosis of node metastases in breast carcinoma; these assays allow to quickly isolate, amplify and quantify mRNA encoding for proteins selectively present in neoplastic cells, as Cytokeratine-19 (CK-19). One Step Nucleic Acid Amplification (OSNA) is routinely used in diagnosis of node metastasis in sentinel lymph node (SNL) of patients affected from breast cancer. The aim of this study is to evaluate if application of OSNA to intraoperative diagnosis of node metastases of PTC is possible.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with preoperative cytological diagnosis of papillary thyroid carcinoma (Tir4-Tir5)
Key inclusion criteria (1 listed)
- Preoperative diagnosis of thyroid carcinoma
Key exclusion criteria (1 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 |
|---|---|---|
| OSNA testAnalysis of lymph node with OSNA | Diagnostic test | – |
Primary outcome
Accuracy of OSNA
Time frame: 1 day
Measurement of OSNA accuracy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
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Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
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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.
Pietro Giorgio Calò principal investigator
University of Cagliari
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 Papillary 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: status not confirmed, as of the sponsor's last update on 26 Mar 2019. 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 Fabio Medas (+393206836288, fabiomedas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of OSNA (time frame: 1 day). 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 Mar 2019.