NCT00148213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
Last Updated

September 7, 2005

Status Verified

September 1, 2005

First QC Date

September 6, 2005

Last Update Submit

September 6, 2005

Conditions

Thyroid Neoplasms

Keywords

differentiated thyroid carcinomathyroglobulinimmunoassaythyroidectomyradioiodine therapy

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, Münster University Hospital

Münster, 48129, Germany

Location

Related 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;50:A73.

    RESULT

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Martin Biermann, MD

    Münster University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

September 1, 2003

Study Completion

June 1, 2005

Last Updated

September 7, 2005

Record last verified: 2005-09

Locations

DE(1)