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Search / Trial NCT05078853

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

Launched by SOROKA UNIVERSITY MEDICAL CENTER · Oct 14, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Differentiated Thyroid Carcinoma Papillary Thyroid Carcinoma Cervical Lymph Nodes Metastases Thyroglobulin Washout Point Of Care Assay

ClinConnect Summary

This clinical trial is studying a new test called the Point of Care Thyroglobulin (POC-Tg) assay, which aims to quickly detect metastatic differentiated thyroid cancer (DTC) in lymph nodes. Currently, when doctors suspect cancer in the lymph nodes based on neck ultrasound results, they perform a biopsy and have to wait several days to weeks for results. This delay can affect how quickly patients receive treatment. The POC-Tg test could provide results in just minutes, helping to make faster and more informed treatment decisions.

To participate in this trial, patients must be at least 18 years old and able to sign a consent form. They can be individuals who are being evaluated for thyroid issues or those undergoing surgery for known thyroid cancer. The trial will involve around 250 patients across different clinics and operating rooms. Participants can expect their lymph nodes to be tested using both the traditional method and the new POC-Tg test, allowing researchers to compare the effectiveness of both approaches. Importantly, pregnant women are not eligible to join this study.

Gender

ALL

Eligibility criteria

  • 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).
  • -
  • Exclusion Criteria:
  • Pregnant women
  • -

About Soroka University Medical Center

Soroka University Medical Center is a leading academic medical institution located in Beer Sheva, Israel, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a key player in the Israeli healthcare system, Soroka integrates cutting-edge medical practice with extensive educational programs, fostering a collaborative environment for researchers, clinicians, and students. The center specializes in a wide range of medical fields, emphasizing patient-centered care and evidence-based practices. With a focus on advancing medical knowledge and improving patient outcomes, Soroka University Medical Center actively sponsors and conducts clinical trials that contribute to significant breakthroughs in various therapeutic areas.

Locations

Ashkelon, , Israel

Beer Sheva, , Israel

Ramat Gan, Select A State, Israel

Jerusalem, , Israel

Tel Aviv, , Israel

Patients applied

0 patients applied

Trial Officials

Uri Yoel, M.D.

Principal Investigator

Soroka University Medical Center, Beer Sheva, Israel

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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