Thyroid NoduleNCT04759053
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules
A study testing FNB and Core biopsy in people with Thyroid Nodule and Thyroid Diseases, run by Kafrelsheikh University.
Trial summary
The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Nodule, Thyroid Diseases, Thyroid Gland; Node
- What is being tested?
- FNB and Core biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Feb 2018
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with nodules larger than 1 cm in diameter and suspicious ultrasound criteria with TIRADS category III or higher.
Who cannot join
- Patients with a history of hemodynamic instability or inadequate coagulation profile were excluded
About this study
Official title: Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules, A Prospective Study
The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy.
- Conditions
- Thyroid Nodule, Thyroid Diseases, Thyroid Gland; Node
- Being tested
- FNB, Core biopsy
- Keywords
- Thyroid nodule, Core needle biopsy, FNB
- Medical subject headings
- Thyroid Nodule, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNBProcedure or surgery
Fine needle aspiration from the nodules
Core biopsyProcedure or surgery
Core biopsy from thyroid nodules
| Study group | Role | What they receive |
|---|---|---|
| FNB | Active comparator | Not described Receives: Procedure: FNB; Procedure: Core biopsy |
| Core biopsy | Active comparator | Not described Receives: Procedure: FNB; Procedure: Core biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of samples in FNB and CNB matching the final pathology
Comparing number of samples in FNB and CNB that make same diagnosis as the final postoperative pathology
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion1 Feb 2018
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.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Principal investigator, Ahmed Aouf, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759053
- Sponsor's protocol ID
- 124569124577
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules, A Prospective Study
- ClinicalTrials.gov ID
- NCT04759053
- Acronym / sponsor ID
- 124569124577
- Conditions
- Thyroid Nodule, Thyroid Diseases, Thyroid Gland; Node
- Keywords
- Thyroid nodule, Core needle biopsy, FNB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 17 Feb 2021 (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.
The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FNB | Active comparator | Procedure: FNB, Procedure: Core biopsy |
| Core biopsy | Active comparator | Procedure: FNB, Procedure: Core biopsy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with nodules larger than 1 cm in diameter and suspicious ultrasound criteria with TIRADS category III or higher.
Key exclusion criteria (1 listed)
- Patients with a history of hemodynamic instability or inadequate coagulation profile 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 |
|---|---|---|
| FNBFine needle aspiration from the nodules | Procedure or surgery | Core biopsy, FNB |
| Core biopsyCore biopsy from thyroid nodules | Procedure or surgery | Core biopsy, FNB |
Primary outcome
Number of samples in FNB and CNB matching the final pathology
Time frame: 7 days
Comparing number of samples in FNB and CNB that make same diagnosis as the final postoperative pathology
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 17 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FNB and Core biopsy in people with Thyroid Nodule and Thyroid Diseases, run by Kafrelsheikh 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 17 Feb 2021. 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?
Number of samples in FNB and CNB matching the final pathology (time frame: 7 days). 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 17 Feb 2021.