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

NCT05078853 | Completed

• 1 other identifier: SCRC21021CTIL
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Differentiated thyroid carcinoma; Papillary thyroid carcinoma; Cervical lymph nodes metastases; Thyroglobulin washout; Point of care assay

Outcome Measures

Primary Outcomes (2)

• Accurate diagnosis of cervical lymph node in the FNA clinic being benign or malignant

  Sensitivity and specificity of the POC-Tg for the detection of DTC metastases to cervical LN compared to the current accepted evaluation

  Up to 1 year following POC-Tg assessment

• Accurate diagnosis of suspicious cervical lymph node in the operating room being benign or malignant

  Sensitivity and specificity of the POC-Tg for the detection of DTC metastases to cervical LN compared to the current accepted evaluation

  Up to 1 year following POC-Tg assessment

Study Arms (2)

Formal/standard evaluation of a suspected cervical lymph node

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.

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

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.

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

Interventions

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

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.

Also known as: POC-Tg

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

FNA Clinic: Patients evaluated in FNA clinic for cervical lymph node/s suspected as DTC metastasis. Operating room: Patients operated for known or suspected DTC with cervical lymph node/s metastasis.

You may qualify if:

• 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).

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (5)

Barzilai Medical Center

Ashkelon, Israel

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Hebrew University Medical Center, Mount Scopus

Jerusalem, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

A.R.M Medical Center, Assuta Ramat Hahayal

Tel Aviv, 69710, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

FNA washout from cervical lymph node suspected as differentiated thyroid carcinoma metastasis

MeSH Terms

Conditions

Lymphatic Metastasis; Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Uri Yoel, M.D.

  Soroka University Medical Center, Beer Sheva, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Uri Yoel

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 15, 2021
• Study Start: October 6, 2021
• Primary Completion: April 22, 2026
• Study Completion: April 22, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

IL (5)