Thyroid CancerMPTNNCT05323669
Molecular Profile of Thyroid Nodules
An observational study of Thyroid Cancer and Thyroid Nodule, run by Belarusian State Medical University.
Trial summary
Profiling and comparative analysis of genomic alterations and miRNA expression in benign and malignant thyroid tumors using histological and cytological specimens will be performed. Obtained information is necessary to create a molecular test to refine the cancer risk of cytologically indeterminate thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodule
- What is being tested?
- Molecular testing
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2022to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Population of the Republic of Belarus
Who may be able to join
- Patients operated on for malignant and benign thyroid tumors. Age is greater than or equal to 18 years old.
Who cannot join
- no
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of Molecular-genetic Profile of Thyroid Nodules
Profiling and comparative analysis of genomic alterations and miRNA expression in benign and malignant thyroid tumors using histological and cytological specimens will be performed. Obtained information is necessary to create a molecular test to refine the cancer risk of cytologically indeterminate thyroid nodules.
Read the detailed description
This is an non-randomised retrospective study consisting of 2 parts. Part A. Histological specimens (formalin fixed paraffin embedded) of patients who were operated on for benign and malignant thyroid disorders will undergo molecular testing to create a molecular profile of thyroid nodules characteristic of Belarusian population.
Part B. Fixed cytological smears of indeterminate thyroid nodules (categories III, IV and V according to Bethesda scoring system) of operated patients will undergo molecular testing to evaluate the possibility and reliability of molecular testing of fixed cytological smears using available assays.
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Being tested
- Molecular testing
- Keywords
- thyroid cancer, thyroid nodule, miRNA, molecular testing
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular testingDiagnostic test
Molecular testing of thyroid nodules
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profile of thyroid nodules
To develop a molecular profile of thyroid nodules that will allow to distinguish benign from malignant tumor
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start11 Apr 2022 (estimated)
- Primary completion29 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belarusian State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute of Genetics and Cytology National Academy of Sciences of Belarus, Minsk City Clinical Oncologic Centre
- Responsible party
- Principal investigator, Siarhei Yakubouski, Belarusian State Medical University
- Investigators
- Gennadij G Kondratenko, MD PhD Prof, Study director, Belarusian State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323669
- Sponsor's protocol ID
- 20220367
- Acronym
- MPTN
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Molecular-genetic Profile of Thyroid Nodules
- ClinicalTrials.gov ID
- NCT05323669
- Acronym / sponsor ID
- MPTN / 20220367
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Keywords
- thyroid cancer, thyroid nodule, miRNA, molecular testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Belarusian State Medical UniversityUniversity, hospital or other
- Collaborators
- The Institute of Genetics and Cytology National Academy of Sciences of Belarus, Minsk City Clinical Oncologic Centre
- Study start
- 11 Apr 2022 (estimated)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Apr 2022 (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.
Profiling and comparative analysis of genomic alterations and miRNA expression in benign and malignant thyroid tumors using histological and cytological specimens will be performed. Obtained information is necessary to create a molecular test to refine the cancer risk of cytologically indeterminate thyroid nodules.
Detailed description
This is an non-randomised retrospective study consisting of 2 parts. Part A. Histological specimens (formalin fixed paraffin embedded) of patients who were operated on for benign and malignant thyroid disorders will undergo molecular testing to create a molecular profile of thyroid nodules characteristic of Belarusian population.
Part B. Fixed cytological smears of indeterminate thyroid nodules (categories III, IV and V according to Bethesda scoring system) of operated patients will undergo molecular testing to evaluate the possibility and reliability of molecular testing of fixed cytological smears using available assays.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of the Republic of Belarus
Key inclusion criteria (1 listed)
- Patients operated on for malignant and benign thyroid tumors. Age is greater than or equal to 18 years old.
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| Molecular testingMolecular testing of thyroid nodules | Diagnostic test | – |
Primary outcome
Molecular profile of thyroid nodules
Time frame: 2 years
To develop a molecular profile of thyroid nodules that will allow to distinguish benign from malignant tumor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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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.
Gennadij G Kondratenko, MD PhD Prof study director
Belarusian State Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Thyroid Nodule, run by Belarusian State Medical 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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siarhei U Yakubouski, MD PhD (5032186 ext. +37529, yakub-2003@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular profile of thyroid nodules (time frame: 2 years). 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 12 Apr 2022.