Thyroid NoduleThyroPred-1NCT03392402
Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
An observational study of Thyroid Nodule and Thyroid Neoplasm, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
This study evaluates the usefulness of molecular classifier to aid the diagnosis of malignancy in the material obtained by fine-needle aspiration biopsy (FNAB) of thyroid nodule. All participants will undergo FNAB with routine cytological assessment and molecular testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule, Thyroid Neoplasm, Thyroid Cancer
- How many people
- 599 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2017to 31 Dec 2020
- 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: Adult patients (above 18 years old) diagnosed with a thyroid nodule, in whom the fine-needle aspiration biopsy is undertaken to establish the necessity of thyroid surgery
Who may be able to join
- a diagnosis of thyroid nodule
- considerable chance for surgical procedure following biopsy result
- patient's consent for collection of material during routine fine needle aspiration biopsy
Who cannot join
- age below 18 years
- the presence of contraindications that make surgical treatment impossible
- prior diagnosis of thyroid cancer
- antithrombotic treatment except of acetylsalicylic acid or low molecular weight heparin at a prophylactic dose
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Gliwice, 44-101
About this study
Official title: Prospective Validation of the Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
This study evaluates the usefulness of molecular classifier to aid the diagnosis of malignancy in the material obtained by fine-needle aspiration biopsy (FNAB) of thyroid nodule. All participants will undergo FNAB with routine cytological assessment and molecular testing. Patients will undergo surgery or be followed-up, according to the clinical guidelines. The diagnostic power of combined molecular/clinical classifier will be compared to prediction based on clinical features only, by investigators blinded to the final diagnosis of surgical assessment.
Read the detailed description
Currently, the diagnosis of malignancy of thyroid nodule is based on cytological assessment of fine-needle aspiration biopsy (FNAB) classified according to the Bethesda System for Reporting of Thyroid Cytopathology. This does not allow for the definitive diagnosis of cancer in significant proportion of tumors, so called indeterminate nodules (Bethesda class III, IV and V). These patients require surgery to establish a definitive diagnosis, leading to unnecessary operating procedures in at least 2/3 of subjects.
Molecular classifiers could significantly improve thyroid preoperative diagnostics, although they are not optimal and provide either high specificity to the detriment of low sensitivity or conversely, relatively low specificity with high sensitivity. The classifiers could be based on gene expression or mutations present in FNAB specimen.
In the present study the investigators plan to assess the improvement of classification power by molecular gene-expression-based multi-feature classifier when added to standard clinical parameters indicating the risk of malignancy (Bethesda class, tumor size, patient age and sex). Participants will undergo FNAB with prospective collection of material for molecular testing and simultaneous preoperative recording of all clinical parameters. The patients will be operated on or followed-up according to the clinical guidelines. The comparison of a predictive power of clinical criteria to the combined clinical-molecular classifier will be carried out by the group of investigators blinded to the results of final surgery.
- Conditions
- Thyroid Nodule, Thyroid Neoplasm, Thyroid Cancer
- Keywords
- Thyroid nodule, Indeterminate thyroid nodule, Molecular biopsy, Gene expression classifier
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy in patients with indeterminate FNAB results who undergone surgery within 6 months from biopsy
The improvement in accuracy of classification will be compared between sole clinical criteria (Bethesda class, tumor size, age, and sex) and combined classifier built on both clinical parameters and gene expression data. The population of indeterminate nodules will be defined by expert analysis of cytological samples by pathologists blinded to the outcome of surgery. Diagnostic accuracy will defined as the percentage of patients who were correctly diagnosed as benign or malignant based on the data available preoperatively.
Measured: until surgery or 6 months from biopsy
Secondary outcomes (1)
Diagnostic accuracy in all patients recruited to the study, who were operated on or remained in follow-up for at least 24 months from biopsy.
The improvement in accuracy of classification will be compared between sole clinical criteria (Bethesda class, tumor size, age, and sex) and combined classifier built on both clinical parameters and gene expression data. All patients after surgery will be included. Tumors in patients not operated on will be considered benign after confirmation of stable tumor status at least with 24 months follow-up. Patients not operated on and with shorter follow-up will be excluded.
Measured: until surgery or 24 months from biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Jan 2017
- Primary completion31 Mar 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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
- Prospective
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Jarzab, MD, PhD, Study chair, Maria Sklodowska-Curie National Research Institute of OncologyRafal Tarnawski, MD, PhD, Study director, Maria Sklodowska-Curie National Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392402
- Sponsor's protocol ID
- 267398/4/NCBR/2015/1
- Acronym
- ThyroPred-1
- Status last verified
- Jul 2021
- First submitted
- 2 Jan 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of the Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
- ClinicalTrials.gov ID
- NCT03392402
- Acronym / sponsor ID
- ThyroPred-1 / 267398/4/NCBR/2015/1
- Conditions
- Thyroid Nodule, Thyroid Neoplasm, Thyroid Cancer
- Keywords
- Thyroid nodule, Indeterminate thyroid nodule, Molecular biopsy, Gene expression classifier
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 Jan 2018 (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.
This study evaluates the usefulness of molecular classifier to aid the diagnosis of malignancy in the material obtained by fine-needle aspiration biopsy (FNAB) of thyroid nodule. All participants will undergo FNAB with routine cytological assessment and molecular testing. Patients will undergo surgery or be followed-up, according to the clinical guidelines. The diagnostic power of combined molecular/clinical classifier will be compared to prediction based on clinical features only, by investigators blinded to the final diagnosis of surgical assessment.
Detailed description
Currently, the diagnosis of malignancy of thyroid nodule is based on cytological assessment of fine-needle aspiration biopsy (FNAB) classified according to the Bethesda System for Reporting of Thyroid Cytopathology. This does not allow for the definitive diagnosis of cancer in significant proportion of tumors, so called indeterminate nodules (Bethesda class III, IV and V). These patients require surgery to establish a definitive diagnosis, leading to unnecessary operating procedures in at least 2/3 of subjects.
Molecular classifiers could significantly improve thyroid preoperative diagnostics, although they are not optimal and provide either high specificity to the detriment of low sensitivity or conversely, relatively low specificity with high sensitivity. The classifiers could be based on gene expression or mutations present in FNAB specimen.
In the present study the investigators plan to assess the improvement of classification power by molecular gene-expression-based multi-feature classifier when added to standard clinical parameters indicating the risk of malignancy (Bethesda class, tumor size, patient age and sex). Participants will undergo FNAB with prospective collection of material for molecular testing and simultaneous preoperative recording of all clinical parameters. The patients will be operated on or followed-up according to the clinical guidelines. The comparison of a predictive power of clinical criteria to the combined clinical-molecular classifier will be carried out by the group of investigators blinded to the results of final surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (above 18 years old) diagnosed with a thyroid nodule, in whom the fine-needle aspiration biopsy is undertaken to establish the necessity of thyroid surgery
Key inclusion criteria (3 listed)
- a diagnosis of thyroid nodule
- considerable chance for surgical procedure following biopsy result
- patient's consent for collection of material during routine fine needle aspiration biopsy
Key exclusion criteria (4 listed)
- age below 18 years
- the presence of contraindications that make surgical treatment impossible
- prior diagnosis of thyroid cancer
- antithrombotic treatment except of acetylsalicylic acid or low molecular weight heparin at a prophylactic dose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy in patients with indeterminate FNAB results who undergone surgery within 6 months from biopsy
Time frame: until surgery or 6 months from biopsy
The improvement in accuracy of classification will be compared between sole clinical criteria (Bethesda class, tumor size, age, and sex) and combined classifier built on both clinical parameters and gene expression data. The population of indeterminate nodules will be defined by expert analysis of cytological samples by pathologists blinded to the outcome of surgery. Diagnostic accuracy will defined as the percentage of patients who were correctly diagnosed as benign or malignant based on the data available preoperatively.
1 secondary outcome
Diagnostic accuracy in all patients recruited to the study, who were operated on or remained in follow-up for at least 24 months from biopsy.
Time frame: until surgery or 24 months from biopsy
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 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Barbara Jarzab, MD, PhD study chair
Maria Sklodowska-Curie National Research Institute of Oncology
Rafal Tarnawski, MD, PhD study director
Maria Sklodowska-Curie National Research Institute of Oncology
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 Thyroid Nodule and Thyroid Neoplasm, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 3 inclusion and 4 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 5 Sep 2021. 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 Poland. 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?
Diagnostic accuracy in patients with indeterminate FNAB results who undergone surgery within 6 months from biopsy (time frame: until surgery or 6 months from biopsy). 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 5 Sep 2021.