Prediction Hypothyroidism Patients Using Machine Learning AlgorithmsNCT06112886
Identification of Important Symptoms and Diagnostic Hypothyroidism Patients Using Machine Learning Algorithms
An observational study of Prediction Hypothyroidism Patients Using Machine Learning Algorithms and Identification of Important Symptoms of Hypothyroidism, run by Kerman University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediction Hypothyroidism Patients Using Machine Learning Algorithms, Identification of Important Symptoms of Hypothyroidism
- How many people
- 1,296 participants
- Where
- 1 siteIran
- Study dates
- 12 Sep 2022to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of Hypothyroidism Disease
- aged 18 years or more
Who cannot join
- Having history of Hypothyroidism treatment and thyroid gland surgery
- Having HT during previous pregnancies
Trial locations and contacts
1 site in 1 country.
Iran1 site
Faculty of Health, Kerman University of Medical Sciences
Kerman, 7616913555
About this study
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.
Read the detailed description
Hypothyroidism (HT) is one of the most common diseases in the world, in which insufficient thyroid hormone is produced. Due to the wide variation in clinical symptoms, the definition of HT is mainly biochemical. Ninety nine percent of primary cases of HT are related to deficiency of thyroxine (T4) and triiodothyronine (T3) hormones. Deficiency in T4 and T3 hormones, which are produced by thyroid gland, leads to increasing thyroid-stimulating hormone (TSH) production through a negative feedback mechanism .
HT has non-specific symptoms such as weight gain, fatigue, insufficient concentration, depression, menstrual irregularities, and constipation, which change with age, gender, and other factors. Autoimmune thyroiditis (Hashimoto's disease) is the most common symptom of this disorder.
The prevalence of HT is 2% in the world, even in the existence of enough iodine in daily food. In a cohort study that was conducted in Iran in 2017, a significant increase in the prevalence of thyroid dysfunction was reported, from 1.4 to 10.5, attributed to several factors such as geographical areas, aging, ethnicity and the amount of iodine intake.
Increasing in serum cholesterol levels and the risk of coronary artery disease and cardiovascular mortality are the most common complications of HT. The economic burden of HT is fairly high, especially in patients with other underlying diseases such as diabetes and hemodialysis. The common clinical method for diagnosing equally primary HT is to check the serum concentration of TSH; People with TSH and T4 levels above the reference age range are diagnosed as hypothyroid. The upper limit of the TSH reference range usually increases with age in adults .
In recent years, artificial intelligence and machine learning techniques have attracted increasing attention from medical researchers. Among the most attractive features of machine learning in medicine are disease prediction and diagnosis of simple symptoms . The prediction models such as support vector machine (SVM), decision tree (DT), random forest (RF) and artificial neural network (ANN), are among the most popular machine learning methods.
As accurate diagnostic of HT is currently based on the TSH level obtained by a blood test, it creates some expense burden and anxiety for patients. The aim of the present study is to first diagnose HT in new cases that have no history of HT symptoms with three statistical machine learning methods (logistic regression, decision tree and random forest). The diagnosis is performed using simple and widely-accepted visual symptoms of HT that endocrinologists identify. Second, the most important visual features of HT which can help physicians in diagnosis, are also ranked using decision tree and random forest methods.
- Conditions
- Prediction Hypothyroidism Patients Using Machine Learning Algorithms, Identification of Important Symptoms of Hypothyroidism
- Being tested
- There was no intervention in this study
- Keywords
- Hypothyroidism, Machine learning algorithms, Random Forest, Decision tree, Logistic regression
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There was no intervention in this studyOther
There was no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| with Hypothyroidism, without Hypothyroidism | Not described Receives: Other: There was no intervention in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start12 Sep 2022
- Primary completion12 Sep 2022
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediction Hypothyroidism Patients Using Machine Learning AlgorithmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerman University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salahodin rakhshani rad, Kerman University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112886
- Sponsor's protocol ID
- 401000292
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Important Symptoms and Diagnostic Hypothyroidism Patients Using Machine Learning Algorithms
- ClinicalTrials.gov ID
- NCT06112886
- Acronym / sponsor ID
- 401000292
- Conditions
- Prediction Hypothyroidism Patients Using Machine Learning Algorithms, Identification of Important Symptoms of Hypothyroidism
- Keywords
- Hypothyroidism, Machine learning algorithms, Random Forest, Decision tree, Logistic regression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,296 participants (actual)
- Lead sponsor
- Kerman University of Medical SciencesUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothyroidism (HT) is one of the most common diseases in the world, in which insufficient thyroid hormone is produced. Due to the wide variation in clinical symptoms, the definition of HT is mainly biochemical. Ninety nine percent of primary cases of HT are related to deficiency of thyroxine (T4) and triiodothyronine (T3) hormones. Deficiency in T4 and T3 hormones, which are produced by thyroid gland, leads to increasing thyroid-stimulating hormone (TSH) production through a negative feedback mechanism .
HT has non-specific symptoms such as weight gain, fatigue, insufficient concentration, depression, menstrual irregularities, and constipation, which change with age, gender, and other factors. Autoimmune thyroiditis (Hashimoto's disease) is the most common symptom of this disorder.
The prevalence of HT is 2% in the world, even in the existence of enough iodine in daily food. In a cohort study that was conducted in Iran in 2017, a significant increase in the prevalence of thyroid dysfunction was reported, from 1.4 to 10.5, attributed to several factors such as geographical areas, aging, ethnicity and the amount of iodine intake.
Increasing in serum cholesterol levels and the risk of coronary artery disease and cardiovascular mortality are the most common complications of HT. The economic burden of HT is fairly high, especially in patients with other underlying diseases such as diabetes and hemodialysis. The common clinical method for diagnosing equally primary HT is to check the serum concentration of TSH; People with TSH and T4 levels above the reference age range are diagnosed as hypothyroid. The upper limit of the TSH reference range usually increases with age in adults .
In recent years, artificial intelligence and machine learning techniques have attracted increasing attention from medical researchers. Among the most attractive features of machine learning in medicine are disease prediction and diagnosis of simple symptoms . The prediction models such as support vector machine (SVM), decision tree (DT), random forest (RF) and artificial neural network (ANN), are among the most popular machine learning methods.
As accurate diagnostic of HT is currently based on the TSH level obtained by a blood test, it creates some expense burden and anxiety for patients. The aim of the present study is to first diagnose HT in new cases that have no history of HT symptoms with three statistical machine learning methods (logistic regression, decision tree and random forest). The diagnosis is performed using simple and widely-accepted visual symptoms of HT that endocrinologists identify. Second, the most important visual features of HT which can help physicians in diagnosis, are also ranked using decision tree and random forest methods.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| with Hypothyroidism, without Hypothyroidism | – | Other: There was no intervention in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Hypothyroidism Disease
- aged 18 years or more
Key exclusion criteria (2 listed)
- Having history of Hypothyroidism treatment and thyroid gland surgery
- Having HT during previous pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There was no intervention in this studyThere was no intervention in this study | Other | with Hypothyroidism, without Hypothyroidism |
Primary outcome
physiological parameter
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediction Hypothyroidism Patients Using Machine Learning Algorithms and Identification of Important Symptoms of Hypothyroidism, run by Kerman University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological parameter (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.