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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

Tracking Information
First Submitted Date September 6, 2005
First Posted Date September 7, 2005
Last Update Posted Date September 7, 2005
Study Start Date September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma
Official Title Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma
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.

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 Type Observational
Study Design Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Thyroid Neoplasms
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: September¬†6,¬†2005)
100
Original Enrollment Same as current
Study Completion Date June 2005
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 0 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00148213
Other Study ID Numbers CETAT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor University Hospital Muenster
Original Study Sponsor Same as current
Collaborators Nichols Institute Diagnostika GmbH, Bad Vilbel, Germany
Investigators
Principal Investigator: Martin Biermann, MD Münster University Hospital
PRS Account University Hospital Muenster
Verification Date September 2005