UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053717 |
|---|---|
| Receipt number | R000061300 |
| Scientific Title | Utility of Preoperative Ultrasonography and Fine-Needle Aspiration Cytology in Differentiation Between Benign and Malignant Cervical Lymphadenopathy: A Retrospective Cohort Study |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/02/27 02:00:28 |
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Basic information
Public title
Utility of Preoperative Ultrasonography and Fine-Needle Aspiration Cytology in Differentiation Between Benign and Malignant Cervical Lymphadenopathy: A Retrospective Cohort Study
Acronym
Utility of Preoperative Ultrasonography and Fine-Needle Aspiration Cytology in Differentiation Between Benign and Malignant Cervical Lymphadenopathy: A Retrospective Cohort Study
Scientific Title
Utility of Preoperative Ultrasonography and Fine-Needle Aspiration Cytology in Differentiation Between Benign and Malignant Cervical Lymphadenopathy: A Retrospective Cohort Study
Scientific Title:Acronym
Utility of Preoperative Ultrasonography and Fine-Needle Aspiration Cytology in Differentiation Between Benign and Malignant Cervical Lymphadenopathy: A Retrospective Cohort Study
Region
| Asia(except Japan) |
Condition
Condition
Cervical Lymphadenopathy
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess the diagnostic performance of ultrasonography (US), fine-needle aspiration cytology (FNAC), and their combination with the postoperative histopathological diagnoses of CLA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate the diagnostic value of FNAC and US findings in comparison with postoperative histopathological diagnoses of cervical lymph node excisional biopsy
Key secondary outcomes
Predictive diagnostic radiologic tests
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
All patients with cystic lateral neck lump (More than 10 mm) with no evidence of primary tumor who underwent cervical lymph node excisional biopsy between April 2021 and May 2023 were included.
Key exclusion criteria
The study excluded patients without preoperative US or FNAC evaluations or documentation, as well as those with infectious etiologies, evidence of a primary tumor at clinical examination with endoscopy, past head and neck oncological surgery, neoadjuvant radiotherapy, solid aspect of the neck mass, and patients who did not undergo excisional biopsy.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Faisal |
| Middle name | Mohammed |
| Last name | Ahmed |
Organization
IBB university
Division name
Department of Surgery
Zip code
PO Box 70270
Address
Al-Thora General Hospital, Department of Urology, School of Medicine, Ibb University of Medical Sciences, Ibb, Yemen.
TEL
00967776089579
fmaaa2006@yahoo.com
Public contact
Name of contact person
| 1st name | Faisal |
| Middle name | Mohammed |
| Last name | Ahmed |
Organization
Ibb University
Division name
Department of Surgery
Zip code
PO Box 70270
Address
Al-Thora General Hospital, Department of Urology, School of Medicine, Ibb University of Medical Scie
TEL
00967776089579
Homepage URL
fmaaa2006@yahoo.com
Sponsor or person
Institute
Ibb university
Institute
Department
Personal name
Funding Source
Organization
Ibb university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Ibb University
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibb University
Address
Al-Thora General Hospital, Department of Urology, School of Medicine, Ibb University of Medical Sciences, Ibb, Yemen.
Tel
009674416416
fmaaa2006@yahoo.com
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
| 2024 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective cohort study, that included 214 patients who were managed at Ibb University-affiliated hospitals. All patients with cystic lateral neck lump (More than 10 mm) with no evidence of primary tumor who underwent cervical lymph node excisional biopsy between April 2021 and May 2023 were included.
Main outcome:
Investigate the diagnostic value of FNAC and US findings in comparison with postoperative histopathological diagnoses of cervical lymph node excisional biopsy
Management information
Registered date
| 2024 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061300
