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
Soroka University Medical Center
250 participants
Oct 6, 2021
OBSERVATIONAL
Conditions
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).
Eligibility
Inclusion Criteria9
- Patients who are able and agree to sign the informed consent document.
- Aged 18 years or older.
- In the FNA clinic arm:
- Patients evaluated for thyroid nodule/s suspected or known as DTC, accompanied by cervical LN/s suspected as DTC metastasis.
- 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:
- Patients operated for known DTC (partial or total thyroidectomy, with or without compartmental neck dissection).
- Patients operated for DTC recurrency ('completion' and/or compartmental neck dissection).
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Exclusion Criteria2
- Pregnant women
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Interventions
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.
Locations(5)
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NCT05078853