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Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma

NCT05078853 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-04-24

No results posted yet for this study

Summary

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

  • Differentiated Thyroid Cancer
  • Lymph Node Metastases

Interventions

DEVICE

Point of care assay for thyroglobulin (POC-Tg) evaluation of a suspected cervical lymph node

FNA Clinic: When a bloody material is seen in the needle, 100 µL of 0.9% saline is drawn via the needle into the syringe. The aspirate is then transferred into an Eppendorf tube. 40 µL is aspirated from the Eppendorf tube and dripped into the middle of the sample well of the POC-Tg kit. Two drops of the buffer are then dispensed into the middle of the sample well. The result of the POC-Tg is obtained and documented after 10 minutes. To compare the accuracy of the POC-Tg kit to the formal immunoassay for Tg, 0.9% saline is added to the aspirate that was left in the Eppendorf tube to a final volume of 0.6 mL. This volume is transferred into a gel containing tube and sent to the clinical laboratory that performs Tg measurement. Operating room: When an indeterminate or suspicious LN is found, the LN is dissected and evaluated by both the formal evaluation and the POC-Tg. Following dissection of the LN, the ex-vivo POC-Tg is conducted as described above.

Sponsors & Collaborators

  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • Uri Yoel, M.D. · Soroka University Medical Center, Beer Sheva, Israel

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2026-04-22
Completion
2026-04-22

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078853 on ClinicalTrials.gov