Breast CancerNCT04406779
The Frequency of Thyroid Diseases in Women With Breast Cancer
An observational study of Breast Cancer and Thyroid Diseases, run by Uşak University.
Trial summary
Breast cancer and thyroid disorders are important health challenges commonly encountered in women. The relationship between both conditions still remains unknown. In this study, the frequency of thyroid diseases was investigated in breast cancer patients Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Thyroid Diseases
- What is being tested?
- thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 31 Mar 2017
- 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 to 65 years
- Women only
- Adult, Older adult
Study population: women, aged between 18-65 years who were diagnosed with breast cancer, but not underwent surgery, radiotherapy or chemothreapy were included into the study as patients groups. Age matched healthy controls were enrolled as controls.
Who may be able to join
- women, the age between 18-65 years who were diagnosed with breast cancer, but not underwent surgery, radiotherapy or chemothreapy were included into the study
Who cannot join
- Those with pregnancy, known liver and renal failure, the history of any malignancy other than breast cancer, undergoing a surgical operation due to breast cancer, also those receiving chemotherapy/radiotherapy for the same reason or undergoing partial or complete thyroid surgery or a surgical operation within the past 6 months, and also the patients taking oral anti-diabetic medication, insulin, steroids, thiazide, anti-psychotics and immuno-suppressive medicines affecting the levels of blood glucose, insulin and IR, smokers and those consuming alcohol were excluded
About this study
Breast cancer and thyroid disorders are important health challenges commonly encountered in women. The relationship between both conditions still remains unknown. In this study, the frequency of thyroid diseases was investigated in breast cancer patients
- Conditions
- Breast Cancer, Thyroid Diseases
- Being tested
- thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies
- Medical subject headings
- Breast Neoplasms, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodiesDevice
thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer | Patients with breast cancer Receives: Device: thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies | |
| Control | Healthy patients without breast cancer Receives: Device: thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
to investigate the frequency of thyroid diseases in breast cancer patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Mar 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cevdet Duran, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406779
- Sponsor's protocol ID
- UsakU-Cevdet1
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Thyroid Diseases in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT04406779
- Acronym / sponsor ID
- UsakU-Cevdet1
- Conditions
- Breast Cancer, Thyroid Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 28 May 2020 (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.
Breast cancer and thyroid disorders are important health challenges commonly encountered in women. The relationship between both conditions still remains unknown. In this study, the frequency of thyroid diseases was investigated in breast cancer patients
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer | – | Device: thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodiesPatients with breast cancer |
| Control | – | Device: thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodiesHealthy patients without breast cancer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- women, aged between 18-65 years who were diagnosed with breast cancer, but not underwent surgery, radiotherapy or chemothreapy were included into the study as patients groups. Age matched healthy controls were enrolled as controls.
Key inclusion criteria (1 listed)
- women, the age between 18-65 years who were diagnosed with breast cancer, but not underwent surgery, radiotherapy or chemothreapy were included into the study
Key exclusion criteria (1 listed)
- Those with pregnancy, known liver and renal failure, the history of any malignancy other than breast cancer, undergoing a surgical operation due to breast cancer, also those receiving chemotherapy/radiotherapy for the same reason or undergoing partial or complete thyroid surgery or a surgical operation within the past 6 months, and also the patients taking oral anti-diabetic medication, insulin, steroids, thiazide, anti-psychotics and immuno-suppressive medicines affecting the levels of blood glucose, insulin and IR, smokers and those consuming alcohol were excluded
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 |
|---|---|---|
| thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodiesthyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies | Device | Control, Patients with breast cancer |
Primary outcome
to investigate the frequency of thyroid diseases in breast cancer patients.
Time frame: 1 year
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 28 May 2020.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Thyroid Diseases, run by Uşak University.
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 1 inclusion and 1 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 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
to investigate the frequency of thyroid diseases in breast cancer patients. (time frame: 1 year). 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 28 May 2020.