Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148213
Status:
COMPLETED
Last Update Posted:
2005-09-07
First Post:
2005-09-06
Brief Title:
Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
Official Title:
Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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 mUl All patients were staged by clinical examination cervical ultrasound 75 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 -20C 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None