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

This study has been completed.
Sponsor:
Collaborator:
Nichols Institute Diagnostika GmbH, Bad Vilbel, Germany
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00148213
First received: September 6, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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
Thyroid Neoplasms

Study Type: Observational
Study Design: Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Estimated Enrollment: 100
Study Start Date: September 2003
Estimated Study Completion Date: June 2005
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).

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148213

Locations
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
Principal Investigator: Martin Biermann, MD Münster University Hospital
  More Information

Publications:
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.

ClinicalTrials.gov Identifier: NCT00148213     History of Changes
Other Study ID Numbers: CETAT
Study First Received: September 6, 2005
Last Updated: September 6, 2005
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
differentiated thyroid carcinoma
thyroglobulin
immunoassay
thyroidectomy
radioiodine therapy

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014