Role of Preoperative Serum Thyroglobulin Level to Differentiate Between Different Thyroid Nodules

December 4, 2023 updated by: Ahmed Gamal Hussein Hasan, Assiut University
Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Incidence of thyroid nodules varies according to the methods of diagnosis, 4-7% by palpation and 17-67% by high resolution ultrasound.

The gold standard of diagnosis for thyroid nodules is fine needle aspiration (FNA); however, fine needle aspiration cytology (FNAC) alone is insufficient to detect cancer because of inadequate cytology (5-15%) and in cases of follicular neoplasm (15-25%) where only surgery is diagnostically conclusive. Therefore, other factors in addition to FNA should be considered to predict malignancy. This study is done to evaluate the association between elevated pre-operative thyroglobulin levels and histopathologically proven thyroid carcinoma.

Metabolism of thyroglobulin occurs in the liver and via thyroid gland and recycling of the protein takes place. Circulating thyroglobulin features a half lifetime of 65 hours. Following thyroidectomy, it will take many weeks before thyroglobulin levels become undetectable. After thyroglobulin levels become undetectable (following thyroidectomy), levels are often serially monitored.

A subsequent elevation of the thyroglobulin level is an indicator of recurrence of papillary or follicular thyroid carcinoma. Hence, thyroglobulin levels in the blood are mainly used as a tumor marker for certain kinds of thyroid cancer (particularly papillary or follicular thyroid cancer). Thyroglobulin is not produced by medullary or anaplastic carcinoma.

Therefore, this study tries to evaluate the association between the preoperative thyroglobulin levels and thyroid carcinoma proven by post-operative histopathology.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age between 15 to 70 years old
  2. patients with solitary thyroid nodules
  3. pateints who are fit for surgeries

Exclusion Criteria:

  • 1_patients who are unfit for surgeries

    2_ age below 15 years and above 70 years old

    3-patients with thyroid nodule receiving drugs that affect thyroglobulin level as iodine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with thyoid nodules
Patients with thyroid nodules that will do thyroidectomy
Procedure: Thyriodectomy
Thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules
Time Frame: Two year
Use of serum thyroglobulin to differentiate between different thyroid nodules preoperoperatively
Two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mohamed Baker, Prof, Assiut University
  • Study Director: Mahmoud Thabet, Assistant.prof, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2023

Primary Completion (Estimated)

November 18, 2024

Study Completion (Estimated)

November 25, 2024

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Estimated)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thyroglobulin level

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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