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Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma

Not Enrolling
Thyroid Neoplasms

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Trial Information

Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma

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).

Inclusion Criteria:

- histological diagnosis of differentiated thyroid carcinoma

- total or near total thyroidectomy

- informed consent

Exclusion Criteria:

- no informed consent

Type of Study:


Study Design:

Additional Descriptors: Convenience Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Principal Investigator

Martin Biermann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Münster University Hospital


Germany: Ethics Commission

Study ID:




Start Date:

September 2003

Completion Date:

June 2005

Related Keywords:

  • Thyroid Neoplasms
  • differentiated thyroid carcinoma
  • thyroglobulin
  • immunoassay
  • thyroidectomy
  • radioiodine therapy
  • Neoplasms
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases