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

Thyroid Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148213
• Other study ID #: CETAT
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: September 6, 2005
• Start date: September 2003
• Est. completion date: June 2005

Study information

• Verified date: September 2005
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• histological diagnosis of differentiated thyroid carcinoma

• total or near total thyroidectomy

• informed consent

Exclusion Criteria:

• no informed consent

Study Design

Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
Germany	Department of Nuclear Medicine, Münster University Hospital	Münster

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Nichols Institute Diagnostika GmbH, Bad Vilbel, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Biermann M, Nofer JR, Riemann B, Lu J, Wilde J, Schober O. Clinical evaluation of a new highly sensitive thyroglobulin assay (Nichols Advantage®) in 99 patients with differentiated thyroid cancer (DTC) after total thyroidectomy [Abstract]. Clin Chem. 2004