UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001239 |
|---|---|
| Receipt number | R000001512 |
| Scientific Title | Role of intraoperative frozen section for thyroid nodules |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2008/07/10 12:56:31 |
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Basic information
Public title
Role of intraoperative frozen section for thyroid nodules
Acronym
Role of intraoperative frozen section for thyroid nodules
Scientific Title
Role of intraoperative frozen section for thyroid nodules
Scientific Title:Acronym
Role of intraoperative frozen section for thyroid nodules
Region
| South America |
Condition
Condition
the utility of intraoperative frozen section (FS) during thyroidectomy is controversial.
Classification by specialty
| Endocrine surgery | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the frozen section role for thyroid nodules management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
All patients having thyroid surgery for nodular disease and previous USG-guided FNAB in 2006 were prospectively analyzed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
All patients having thyroid surgery for nodular disease and previous USG-guided FNAB in 2006 were prospectively analyzed. They underwent intraoperative FS evaluation being classified as benign, malignant or follicular neoplasm. FNAB, FS and paraffin sections were compared.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive series.
Key exclusion criteria
No.
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rogerio A. Dedivitis |
Organization
Fundacao Lusiada Medical School
Division name
Department of Head and Neck Surgery
Zip code
Address
Rua Olinto Rodrigues Dantas 343 cj. 92 - 11050-220 Santos SP, Brazil
TEL
55-13-3223-5550
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rogerio A. Dedivitis |
Organization
Fundacao Lusiada Medical School
Division name
Department of Head and Neck Surgery
Zip code
Address
Rua Olinto Rodrigues Dantas 343 cj. 92 - 11050-220 Santos SP, Brazil
TEL
55-13-3223-5550
Homepage URL
dedivitis.hns@uol.com.br
Sponsor or person
Institute
Fundacao Lusiada Medical School
Institute
Department
Personal name
Funding Source
Organization
Fundacao Lusiada Medical School
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Brazil
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 10 | Day |
Last modified on
| 2008 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001512
