NCT04332770

Brief Summary

This is a prospective observational cohort study. Monitoring continuous biosignals using wearable devices in thyroid cancer patients who are planned to withdraw their levothyroxine for radioactive iodine therapy. Through this, bio signals can be collected in the subjects in hypothyroid status. Physical activity, heart rate, and sleep data will be collected during the study period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

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

June 14, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

December 13, 2019

Last Update Submit

January 3, 2021

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (11)

  • physical activity (steps)

    steps data measured by wearable device, collected and recorded in 1 min increment

    throughout the study period average 4 months

  • heart rate (beats)

    heart rate data measured by wearable device, collected and recorded in 1 min increment

    throughout the study period average 4 months

  • free T4 level (ng/dL)

    thyroid hormone level

    baseline (visit 1)

  • free T4 level (ng/dL)

    thyroid hormone level

    after 2 to 3 months (visit 2)

  • free T4 level (ng/dL)

    thyroid hormone level

    after 3 to 4 months (visit 3)

  • Zulewski hypothyroidism score ( point)

    Scoring system to evaluate hypothyroid symptoms and signs

    baseline (visit 1)

  • Zulewski hypothyroidism score ( point)

    Scoring system to evaluate hypothyroid symptoms and signs

    after 2 to 3 months (visit 2),

  • Zulewski hypothyroidism score ( point)

    Scoring system to evaluate hypothyroid symptoms and signs

    after 3 to 4 months (visit 3)

  • TSH level (mIU/L)

    thyroid stimulating hormone level

    baseline (visit 1)

  • TSH level (mIU/L)

    thyroid stimulating hormone level

    after 2 to 3 months (visit 2)

  • TSH level (mIU/L)

    thyroid stimulating hormone level

    after 3 to 4 months (visit 3)

Study Arms (2)

Hypothyroid group

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

Other: levothyroxine withdrawal

Control group

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

Interventions

levothyroxine withdrawalOTHER

All participants of this study are decided to get radioactive iodine therapy using levothyroxine withdrawal or human recombinant TSH injection prior to the study enrollment. That decision is independent with this study protocol. This study just collect continuous bio signals using wearable devices in the patients undergoing two different preparation methods for radioactive iodine therapy. That is why this study is an observational cohort study.

Hypothyroid group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get radioactive iodine therapy

You may qualify if:

  • Patients with differentiated thyroid carcinoma underwent total thyroidectomy
  • Patients who are planned to get radioactive iodine therapy
  • Patients who are able to use wearable device and smartphones

You may not qualify if:

  • Patients who are not able to use wearable device and smartphones
  • Patients who are maintaining drugs affecting heart rate
  • Patients who have any other disease which can affect biosignals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Jae Hoon Moon, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 13, 2019

First Posted

April 3, 2020

Study Start

June 14, 2019

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)