NCT06112886

Brief Summary

Hypothyroidism (HT) is one of the most common endocrine diseases. It is, however, usually challenging for physicians to diagnose due to non-specific symptoms. The usual procedure for diagnosis of HT is a blood test. In recent years, machine learning algorithms have proved to be powerful tools in medicine due to their diagnostic accuracy. In this study, we aim to predict and identify the most important symptoms of HT using machine learning algorithms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

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 12, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

Same day

First QC Date

October 25, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

HypothyroidismMachine learning algorithmsRandom ForestDecision treeLogistic regression

Outcome Measures

Primary Outcomes (1)

  • physiological parameter

    Information about hypothyroidism was collected by checklist. Then, TSH test was used for each individual to obtain the response variable. People whose TSH level is above 4 mIU/L are identified as hypothyroid. A person whose TSH is between 0.4 and 0.4 mIU/L is considered healthy.

    6 months

Study Arms (1)

with Hypothyroidism, without Hypothyroidism

Other: There was no intervention in this study

Interventions

There was no intervention in this study

with Hypothyroidism, without Hypothyroidism

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe sexual identity of people is based on their physiological appearance
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In total 1296 individuals (1088 women and 208 men) aged 18 years or over participated in this cross-sectional study from September to December 2022 at our main clinic for thyroid treatment.

You may qualify if:

  • Clinical diagnosis of Hypothyroidism Disease
  • aged 18 years or more

You may not qualify if:

  • Having history of Hypothyroidism treatment and thyroid gland surgery
  • Having HT during previous pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health, Kerman University of Medical Sciences

Kerman, 7616913555, Iran

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 2, 2023

Study Start

September 12, 2022

Primary Completion

September 12, 2022

Study Completion

September 20, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

The data is related to the common symptoms of hypothyroidism. Also, this data includes 6 demographic variables. If a researcher conducts research on hypothyroidism and machine learning, he/she can access the data by citing sufficient reasons.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
As soon as satisfactory confirmation is given, the data will be sent. This may take between one and two weeks
Access Criteria
Any research related to hypothyroidism and its diagnosis methods using simple symptoms. Use in the field of machine learning

Locations