Rapid detection of metastatic thyroid cancer using a point of care assay
Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma- A Multi-Center Validation Study
This study is testing a new quick test for thyroid cancer to see if it works better than the usual methods for patients who might have advanced thyroid cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Soroka University Medical Center Academic / other |
| Locations | 5 sites (Ashkelon and 4 other locations) |
| Trial ID | NCT05078853 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a novel point of care assay for thyroglobulin (POC-Tg) in patients with suspected metastatic differentiated thyroid carcinoma (DTC). The study will assess the accuracy of POC-Tg compared to traditional diagnostic methods in both a fine needle aspiration clinic and during surgical procedures. By providing immediate results, the POC-Tg could significantly reduce the waiting time for patients and improve treatment planning. The study will be conducted across multiple centers, with data managed centrally for comprehensive analysis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected or known differentiated thyroid carcinoma and associated cervical lymph node metastases.
Not a fit: Patients who are pregnant or do not consent to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster diagnosis and treatment decisions for patients with metastatic differentiated thyroid carcinoma.
How similar studies have performed: While similar diagnostic approaches have been explored, the specific use of a point of care assay for thyroglobulin in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
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Exclusion Criteria:
Pregnant women
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Where this trial is running
Ashkelon and 4 other locations
- Barzilai Medical Center — Ashkelon, Israel (Recruiting)
- Soroka University Medical Center — Beer Sheva, Israel (Recruiting)
- Hebrew University Medical Center, Mount Scopus — Jerusalem, Israel (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- A.R.M Medical Center, Assuta Ramat Hahayal — Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: Uri Yoel, M.D. — Soroka University Medical Center, Beer Sheva, Israel
- Study coordinator: Uri Yoel, M.D.
- Email: uriy@bgu.ac.il
- Phone: +972548184277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.