Thyroid Neoplasms Clinical Trial
Official title:
Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma
Human thyroglobulin (Tg) is the most sensitive biochemical marker for recurrence of
differentiated cancer (DTC), especially after the complete removal of thyroid tissue through
surgery and radioiodine therapy (RIT).
Unfortunately, current assays for measuring Tg in blood samples are not sensitive enough to
reliably measure Tg while patients are under thyroid hormone replacement therapy. Instead
patients have to withdraw thyroid hormone for several weeks or receive costly injections of
recombinant thyroid stimulating hormone (TSH) in order to raise Tg production by thyroid
remnant and/or thyroid cancer cells so that it can be measured by current Tg assays. Other
patients have antibodies against Tg that interfere in current immunoassays.
The purpose of the study was to characterize a new highly sensitive assay for measuring Tg
in the serum in thyroid cancer patients both on thyroid hormone therapy and off therapy in
comparison to the normal routine assay already in use at Münster University Hospital.
Sera of 100 consecutive DTC patients after total thyroidectomy were to be collected at the
Department of Nuclear Medicine both under TSH-suppression therapy and under endogenous TSH
stimulation (TSH > 25 mU/l). All patients were staged by clinical examination, cervical
ultrasound (7.5 MHz), I-131 whole-body scintigraphy and – where applicable – F18-FDG-PET.
Written informed consent was obtained from all pts. Sera were taken in separation tubes
without anticoagulants and stored at -20°C until analysis. Sera were allowed to come to room
temperature prior to analysis.
Tg, TgR and TgAb concentrations were determined by fully automated two-site
chemiluminescence immunoassays (CLIA; Nichols Advantage®; Nichols Institute Diagnostics, San
Clemente, California). All 3 assays are based on the identical highly purified hTg material
for calibration (Tg), recovery (TgR) and antigen (TgAb; biotinylated and acridinium ester
labeled) for optimum comparability of test results.
In addition, Tg and TgR was measured by a fully automated two-site TRACE immunoassay (BRAHMS
Kryptor®, Brahms AG, Hennigsdorf, Germany) and TSH with a 3rd-generation CLIA assay (TSH-3,
Advia Centaur, Bayer Corporation).
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Primary Purpose: Screening, Time Perspective: Cross-Sectional
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