Thyroid CancerNCT06124469
UNN-RADS Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer
An observational study of Thyroid Cancer and Lymph Node, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
In 2020, Sarda-Inman et al., developed the Ultrasound Neck Node Reporting and Data System (UNN-RADS) scale that allows decision-making about when it is appropriate to perform FNA of a cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins, echogenicity, echogenicity of the hilum… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Thyroid Cancer, Lymph Node
- What is being tested?
- US-guided fine needle aspiration (FNA)
- How many people
- 99 participants
- Where
- 1 siteMexico
- Study dates
- 15 Mar 2022to 1 Nov 2023
- How long will I take part?
- 21 Days
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes at Unidad Médica de Alta Especialidad HE 1 CMN Bajío
Who may be able to join
- 1) had previous history of DTC 2) both sexes with age over 18 years old 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1
Who cannot join
- 1) underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer 2) had previous bilateral cervical lymph node dissection as initial treatment 3) FNA results were not concluded
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad Medica de Alta Especialidad No. 1, Bajío
León, Guanajuato, 37260,
About this study
Official title: Validation of The Ultrasound Neck Node Reporting and Data System (UNN-RADS) Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer
In 2020, Sarda-Inman et al., developed the Ultrasound Neck Node Reporting and Data System (UNN-RADS) scale that allows decision-making about when it is appropriate to perform FNA of a cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins, echogenicity, echogenicity of the hilum, vascularity and the presence/absence of calcifications, and cystic degeneration), features that have been associated with metastatic lymph nodes, with scores ranging from 0 to 3 points, which allows categorize into 5 different risk groups. Thus, the objective of this study is to evaluate the ultrasound characteristics of metastatic LN in patients undergoing TC follow-up and to validate the UNN-RADS scale for the diagnosis of LN Metastasis in Patients with a history of TC.
Read the detailed description
This study enrolled consecutive patients in follow-up for differentiated thyroid cancer (DTC) history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes. Patients were included if they 1) had previous history of DTC, 2) both sexes with age over 18 years old, and 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1. Patients were excluded if they underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer, had previous bilateral cervical lymph node dissection as initial treatment, or the FNA results were not concluded.
UNN-RADS 1 y 2 and UNN-RADS 3, 4 and 5 were grouped for analysis purpose. Diagnostic performance of UNN-RADS scale were assessed in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), positive likelihood ratios (+LR), negative likelihood ratios (-LR) and accuracy, as well as with a receiver operating characteristic (ROC) curve.
- Conditions
- Thyroid Cancer, Lymph Node
- Being tested
- US-guided fine needle aspiration (FNA)
- Keywords
- Lymph node, Thyroid cancer, Ultrasonography, Metastasis
- Medical subject headings
- Thyroid Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided fine needle aspiration (FNA)Diagnostic test
This study enrolled consecutive patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical
| Study group | Role | What they receive |
|---|---|---|
| Benign lymph nodes | Categories UNN-RADS 1 and 2 (test negative) Receives: Diagnostic Test: US-guided fine needle aspiration (FNA) | |
| Metastatic lymph nodes | Categories UNN-RADS 3, 4, and 5 (test positive). Receives: Diagnostic Test: US-guided fine needle aspiration (FNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
metastatic lymph node
Fine needle aspiration biopsy (FNA) results were the gold standard (metastatic or benign).
Measured: All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start15 Mar 2022
- Primary completion23 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Cohort
- Time perspective
- Other
- Enrolment
- 99 participants (actual)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilda Elizabeth Macías Cervantes, Instituto Mexicano del Seguro Social
- Investigators
- Hilda Maciaqs, PhD, Study chair, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124469
- Sponsor's protocol ID
- 3
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated or analyzed during the study are available from the principal investigator on reasonable request.
Publications
Ryu KH, Lee KH, Ryu J, Baek HJ, Kim SJ, Jung HK, Kim SM. Cervical Lymph Node Imaging Reporting and Data System for Ultrasound of Cervical Lymphadenopathy: A Pilot Study. AJR Am J Roentgenol. 2016 Jun;206(6):1286-91. doi: 10.2214/AJR.15.15381. Epub 2016 Apr 12.
PubMed 27070179Ahuja AT, Ying M. Sonographic evaluation of cervical lymph nodes. AJR Am J Roentgenol. 2005 May;184(5):1691-9. doi: 10.2214/ajr.184.5.01841691.
PubMed 15855141Prativadi R, Dahiya N, Kamaya A, Bhatt S. Chapter 5 Ultrasound Characteristics of Benign vs Malignant Cervical Lymph Nodes. Semin Ultrasound CT MR. 2017 Oct;38(5):506-515. doi: 10.1053/j.sult.2017.05.005. Epub 2017 May 20.
PubMed 29031367Ni X, Xu S, Zhan W, Zhou W. Ultrasonographic features of cervical lymph node metastases from medullary thyroid cancer: a retrospective study. BMC Med Imaging. 2022 Aug 29;22(1):151. doi: 10.1186/s12880-022-00882-7.
PubMed 36038830Meyer JE, Steffen A, Bienemann M, Hedderich J, Schulz U, Laudien M, Quetz J, Wollenberg B. Evaluation and development of a predictive model for ultrasound-guided investigation of neck metastases. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):315-20. doi: 10.1007/s00405-011-1611-1. Epub 2011 May 6.
PubMed 21547389Sarda Inman ED, Valdez Rojas AM. Ultrasound Neck Node Reporting and Data System (UNN-RADS) for lymphadenopathy: A structured report. J Mex Fed Radiol Imaging 2022;3:151-163.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of The Ultrasound Neck Node Reporting and Data System (UNN-RADS) Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06124469
- Acronym / sponsor ID
- 3
- Conditions
- Thyroid Cancer, Lymph Node
- Keywords
- Lymph node, Thyroid cancer, Ultrasonography, Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 9 Nov 2023 (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.
In 2020, Sarda-Inman et al., developed the Ultrasound Neck Node Reporting and Data System (UNN-RADS) scale that allows decision-making about when it is appropriate to perform FNA of a cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins, echogenicity, echogenicity of the hilum, vascularity and the presence/absence of calcifications, and cystic degeneration), features that have been associated with metastatic lymph nodes, with scores ranging from 0 to 3 points, which allows categorize into 5 different risk groups. Thus, the objective of this study is to evaluate the ultrasound characteristics of metastatic LN in patients undergoing TC follow-up and to validate the UNN-RADS scale for the diagnosis of LN Metastasis in Patients with a history of TC.
Detailed description
This study enrolled consecutive patients in follow-up for differentiated thyroid cancer (DTC) history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes. Patients were included if they 1) had previous history of DTC, 2) both sexes with age over 18 years old, and 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1. Patients were excluded if they underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer, had previous bilateral cervical lymph node dissection as initial treatment, or the FNA results were not concluded.
UNN-RADS 1 y 2 and UNN-RADS 3, 4 and 5 were grouped for analysis purpose. Diagnostic performance of UNN-RADS scale were assessed in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), positive likelihood ratios (+LR), negative likelihood ratios (-LR) and accuracy, as well as with a receiver operating characteristic (ROC) curve.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 21 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign lymph nodes | – | Diagnostic Test: US-guided fine needle aspiration (FNA)Categories UNN-RADS 1 and 2 (test negative) |
| Metastatic lymph nodes | – | Diagnostic Test: US-guided fine needle aspiration (FNA)Categories UNN-RADS 3, 4, and 5 (test positive). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes at Unidad Médica de Alta Especialidad HE 1 CMN Bajío
Key inclusion criteria (1 listed)
- 1) had previous history of DTC 2) both sexes with age over 18 years old 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1
Key exclusion criteria (1 listed)
- 1) underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer 2) had previous bilateral cervical lymph node dissection as initial treatment 3) FNA results were not concluded
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 |
|---|---|---|
| US-guided fine needle aspiration (FNA)This study enrolled consecutive patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical | Diagnostic test | Benign lymph nodes, Metastatic lymph nodes |
Primary outcome
metastatic lymph node
Time frame: All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.
Fine needle aspiration biopsy (FNA) results were the gold standard (metastatic or benign).
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 9 Nov 2023.
- Results publication: PubMed 27070179Ryu KH, Lee KH, Ryu J, Baek HJ, Kim SJ, Jung HK, Kim SM. Cervical Lymph Node Imaging Reporting and Data System for Ultrasound of Cervical Lymphadenopathy: A Pilot Study. AJR Am J Roentgenol. 2016 Jun;206(6):1286-91. doi: 10.2214/AJR.15.15381. Epub 2016 Apr 12.
- Results publication: PubMed 15855141Ahuja AT, Ying M. Sonographic evaluation of cervical lymph nodes. AJR Am J Roentgenol. 2005 May;184(5):1691-9. doi: 10.2214/ajr.184.5.01841691.
- Results publication: PubMed 29031367Prativadi R, Dahiya N, Kamaya A, Bhatt S. Chapter 5 Ultrasound Characteristics of Benign vs Malignant Cervical Lymph Nodes. Semin Ultrasound CT MR. 2017 Oct;38(5):506-515. doi: 10.1053/j.sult.2017.05.005. Epub 2017 May 20.
- Results publication: PubMed 36038830Ni X, Xu S, Zhan W, Zhou W. Ultrasonographic features of cervical lymph node metastases from medullary thyroid cancer: a retrospective study. BMC Med Imaging. 2022 Aug 29;22(1):151. doi: 10.1186/s12880-022-00882-7.
- Results publication: PubMed 21547389Meyer JE, Steffen A, Bienemann M, Hedderich J, Schulz U, Laudien M, Quetz J, Wollenberg B. Evaluation and development of a predictive model for ultrasound-guided investigation of neck metastases. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):315-20. doi: 10.1007/s00405-011-1611-1. Epub 2011 May 6.
- Results publicationSarda Inman ED, Valdez Rojas AM. Ultrasound Neck Node Reporting and Data System (UNN-RADS) for lymphadenopathy: A structured report. J Mex Fed Radiol Imaging 2022;3:151-163.
- Individual participant dataSharing planned: Yes. The datasets generated or analyzed during the study are available from the principal investigator on reasonable request.
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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.
Hilda Maciaqs, PhD study chair
Instituto Mexicano del Seguro Social
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, run by Instituto Mexicano del Seguro Social 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 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 9 Nov 2023. 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.
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?
metastatic lymph node (time frame: All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.). 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 NCT06124469, which also lists 6 linked publications.
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 9 Nov 2023.