Clinical trial · Observational
Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma
Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma- A Multi-Center Validation Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Despite a favorable prognosis, metastatic cervical lymph nodes (LN), are not uncommon among patients with differentiated thyroid cancer (DTC). Current guidelines recommend that a suspicious cervical LN on neck ultrasound (US) should be investigated with fine needle aspiration biopsy for cytology (FNAC) and for thyroglobulin (Tg) measurement (FNA-Tg), using saline washout of the needle content. Since Tg is a protein produced exclusively by thyroid follicular cells, a positive FNA-Tg result establishes the diagnosis of metastatic DTC. Currently, following LN biopsy, a patient must wait days to weeks to receive results, that directly impacts the treatment plan. This delay may be solved by a point of care assay of the washout Tg (POC-Tg), drawn from a suspicious cervical LN. Another potential novel usage of POC-Tg is the evaluation of suspicious LN found during neck surgery for known or suspicious DTC. Here, the POC-Tg may save the time needed for the completion of 'frozen section'. The study product: POC-Tg is a lateral flow immunoassay for Tg, able to detect within minutes Tg at concentration equal to 5 ng/mL and above (the midrange of the accepted cut-off). Methods: The multi-center validation study will include 100 patients in the FNA clinic, and 150 LN (dissected from 50-150 patients) in the operating room (OR). Each LN will be evaluated using both the formal accepted method (in the FNA clinic, the combination of FNAC and FNA-Tg; and frozen section in the OR), and the novel POC-Tg. Clinical decisions will be made according to the formal evaluation only. In a retrospective analysis, the investigators will estimate the sensitivity and specificity of the POC-Tg and the formal accepted method against the reference ('gold') standard (cytology, histology and follow-up US in the FNA clinic setting, and final histology in the OR setting).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Cancer | — | UNRESOLVED | — |
| Lymph Node Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Point of care assay for thyroglobulin (POC-Tg) evaluation of a suspected cervical lymph node | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Formal/standard evaluation of a suspected cervical lymph node
- description
- Patient with cervical lymph node suspected as differentiated thyroid carcinoma metastasis will be evaluated according to the current accepted American Thyroid Association Guidelines. Two clinical scenarios, for each one of them the formal evaluation is described below: 1. Fine needle aspiration Clinic (a patient with known or suspected differentiated thyroid carcinoma is evaluation for suspicious cervical lymph node): the formal evaluation will include cytology and formal thyroglobulin measurement from the needle washout. 2. Operating room (evaluation of suspicious cervical lymph node found during partial or complete thyroidectomy in patient with known or suspected differentiated thyroid carcinoma): the formal evaluation will include frozen section and/or final histology.
- label
- Point of care assay for thyroglobulin (POC-Tg) evaluation of a suspected cervical lymph node
- description
- Patient with cervical lymph node suspected as differentiated thyroid carcinoma metastasis will be evaluated using the study kit: Novel rapid POC-Tg. Two clinical scenarios, for each one of them the performance of the study kit (POC-Tg) will be valuated in parallel to the formal evaluation: 1. Fine needle aspiration Clinic (a patient with known or suspected differentiated thyroid carcinoma is evaluation for suspicious cervical lymph node): the suspected cervical lymph node will be evaluated using the POC-Tg in parallel to the formal evaluation. 2. Operating room (evaluation of suspicious cervical lymph node found during partial or complete thyroidectomy in patient with known or suspected differentiated thyroid carcinoma): the suspected cervical lymph node will be evaluated using the POC-Tg in parallel to the formal evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients who are able and agree to sign the informed consent document.
2. Aged 18 years or older.
In the FNA clinic arm:
3. Patients evaluated for thyroid nodule/s suspected or known as DTC, accompanied by cervical LN/s suspected as DTC metastasis.
4. Patients following treatment for DTC (partial or total thyroidectomy, with or without compartmental neck dissection), with cervical LN/s suspected as DTC recurrency.
In the OR arm:
5. Patients operated for known DTC (partial or total thyroidectomy, with or without compartmental neck dissection).
6. Patients operated for DTC recurrency ('completion' and/or compartmental neck dissection).
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Exclusion Criteria:
Pregnant women
\-References
Publications (0)
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