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

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ClinicalTrials.gov Identifier: NCT00148213
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : September 7, 2005
Sponsor:
Collaborator:
Nichols Institute Diagnostika GmbH, Bad Vilbel, Germany
Information provided by:
University Hospital Muenster

Study Description
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Brief 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.


Condition or disease
Thyroid Neoplasms

Detailed 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).

Study Design
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Study Type : Observational
Enrollment : 100 participants
Time Perspective: Other
Official Title: Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma
Study Start Date : September 2003
Study Completion Date : June 2005

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   0 Years to 0 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histological diagnosis of differentiated thyroid carcinoma
  • total or near total thyroidectomy
  • informed consent

Exclusion Criteria:

  • no informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148213


Locations
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Germany
Department of Nuclear Medicine, Münster University Hospital
Münster, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
Nichols Institute Diagnostika GmbH, Bad Vilbel, Germany
Investigators
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Principal Investigator: Martin Biermann, MD Münster University Hospital
More Information
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Publications of Results:
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;50:A73.

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ClinicalTrials.gov Identifier: NCT00148213    
Other Study ID Numbers: CETAT
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: September 7, 2005
Last Verified: September 2005
Keywords provided by University Hospital Muenster:
differentiated thyroid carcinoma
thyroglobulin
immunoassay
thyroidectomy
radioiodine therapy
Additional relevant MeSH terms:
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Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Hypersensitivity
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Endocrine System Diseases
Immune System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms