Follow up for Patients With Thyroid Cancer Planed for Radioiodine Scan or Treatment

August 8, 2018 updated by: Taichung Veterans General Hospital
The prevalence of thyroid cancer has increased in recent decades. Patients with thyroid cancer need to choose between Thyrogen® injection and Eltroxin® withdrawal before radioiodine therapy or scan. This is a prospective, observational study, aiming to observe the difference of metabolic profiles between patients choose Thyrogen® injection and Eltroxin® withdrawal.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Objective： To observe the difference between Thyogen® injection or Eltroxin® withdrawal on metabolic profile.
  2. Background and method:： The prevalence of thyroid cancer has increased in recent decades. Patients with thyroid cancer need to choose between Thyrogen® injection and Eltroxin® withdrawal before radioiodine therapy or scan. This is a prospective, observational study, aiming to observe the difference of metabolic profiles between patients choose Thyrogen® injection and Eltroxin® withdrawal.

Inclusion ： Patient number: 500人

Inclusion criteria :

  1. Patients with diagnosis of thyroid cancer。
  2. Patients who need radioiodine therapy or scan。

Exclusion criteria:

  1. Patients cannot cooperate with blood test.。
  2. Patients cannot cooperate with radioiodine therapy。 Study design： Prospective, observational study。

Method： We will collect 20cc blood and 20 cc urine before and after radioiodine therapy during each visit (total 3 visits) and check lipid profiles, glucose profiles and inflammation markers. We will compare the difference between results of patients undergoing Thyrogen® injection and Eltroxin® withdrawal.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Locations

  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
        • Sub-Investigator:
          • I-Te Lee, MD
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of thyroid cancer

Description

Inclusion Criteria:

  1. Patients with diagnosis of thyroid cancer。
  2. Patients who need radioiodine therapy or scan。

Exclusion Criteria:

  1. Patients cannot cooperate with blood test.。
  2. Patients cannot cooperate with radioiodine therapy。

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zung's Self-reported depression scale
Time Frame: 1 month
Depression symtpoms
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain-derived neurotrophic factor
Time Frame: 1 month
BDNF
1 month
orexin
Time Frame: 1 month
An associated factor for depression
1 month
Body composition
Time Frame: 1 months
Fat component percentage to lean mass percentage ratio
1 months
VCAM-1
Time Frame: 1 months
adhesion molecules
1 months
CRP
Time Frame: 1 months
inflammation marker
1 months
Metabolic syndrome
Time Frame: 1 months
The number of conponents for metabolic syndrome
1 months

Collaborators and Investigators

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

Sponsor

Taichung Veterans General Hospital

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 (Actual)

June 30, 2018

Primary Completion (Anticipated)

June 30, 2028

Study Completion (Anticipated)

June 30, 2030

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE18104A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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