Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001482550
Ethics application status
Approved
Date submitted
5/11/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prooxidant-antioxidant balance indicators, adrenal cortex and medullary hormones and growth factors in patients with salivary gland tumours
Scientific title
Prooxidant-antioxidant balance indicators, adrenal cortex and medullary hormones and growth factors pre and post surgery in patients with salivary gland tumours
Secondary ID [1] 312974 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prooxidant-antioxidant balance 335544 0
salivary gland tumours 335545 0
inflammation 335547 0
Condition category
Condition code
Cancer 332113 332113 0 0
Other cancer types
Inflammatory and Immune System 332115 332115 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The subject of the planned research is the evaluation of selected biochemical markers in blood in patients of the Department of Laryngology and Clinic of Laryngology of the Silesian Medical University in Katowice. Patients with diagnosed tumours (benign or malignant) of the parotid glands after prior histopathological verification and computed tomography (CT) were qualified for surgical treatment (superficial parotidectomy - complete removal of the superficial lobe of the parotid gland with preservation of the facial nerve) in the Department of Laryngology.
Blood for biochemical tests will be collected twice, i.e. before and after surgery (after 10 days). The material for testing (whole blood) will be provided by the Department of Laryngology to the Biochemistry Laboratory.

Intervention code [1] 330115 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339763 0
Qualification for surgery
Timepoint [1] 339763 0
The outcome will be assessed before a surgery
Primary outcome [2] 339764 0
Assesment of prooxidant-antioxidant balance
Timepoint [2] 339764 0
The outcome will be assessed before surgery and 10 days after the surgery
Secondary outcome [1] 441158 0
Assesment of adrenal hormones (cortex and medulla). This will be assessed as a composite outcome.
Timepoint [1] 441158 0
The outcome will be assessed before surgery and 10 days after the surgery
Secondary outcome [2] 441159 0
Assesment of muscle damage indicators. This will be assessed as a composite outcome.
Timepoint [2] 441159 0
The outcome will be assessed before surgery and 10 days after the surgery
Secondary outcome [3] 441160 0
Assesment of inflammatory indicators. This will be assessed as a composite outcome.
Timepoint [3] 441160 0
The outcome will be assessed before surgery and 10 days after the surgery

Eligibility
Key inclusion criteria
1.diagnosed tumor (benign or malignant) of the parotid gland after histopathological and computed tomography (CT) verification,
2. voluntary agreement to the examination,
3. at least 18 years of age
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. lack of consent to participate in the study,
2. failure to be available on the scheduled day of surgery,
3. non-qualification for surgery (removal of benign and malignant tumors)
4. health contraindications to the procedure and collection of biological material.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The statistical analysis was performed in Statistica 13 (StatSoft, Poland) or IBM Statistics 26.0 (IBM Corporation, Ar-monk, NY, USA). The sample size was calculated using G*Power version 3.1.9.7, developed by Heinrich 60 Heine University in Düsseldorf, Germany.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/01/2024
Date of last participant enrolment
Anticipated
Actual
17/09/2024
Date of last data collection
Anticipated
Actual
19/09/2024
Sample size
Target
50
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 26661 0
Poland
State/province [1] 26661 0

Funding & Sponsors
Funding source category [1] 317407 0
University
Name [1] 317407 0
Medical University of Silesia, Katowice, Poland
Country [1] 317407 0
Poland
Primary sponsor type
University
Name
Medical University of Silesia, Katowice, Poland
Address
Country
Poland
Secondary sponsor category [1] 319695 0
University
Name [1] 319695 0
Academy of Physical Education in Katowice
Address [1] 319695 0
Country [1] 319695 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316132 0
University Bioethics Committee for Scientific Research at the Academy of Physical Education in Katowice
Ethics committee address [1] 316132 0
Ethics committee country [1] 316132 0
Poland
Date submitted for ethics approval [1] 316132 0
13/02/2023
Approval date [1] 316132 0
30/03/2023
Ethics approval number [1] 316132 0
Resolution no. 1/2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136894 0
Dr Sebastian Bankowski
Address 136894 0
Academy of Physical Education in Katowice, ul. Mikolowska 72A, 40-065 Katowice
Country 136894 0
Poland
Phone 136894 0
+48322075152
Fax 136894 0
Email 136894 0
s.bankowski@awf.katowice.pl
Contact person for public queries
Name 136895 0
Sebastian Bankowski
Address 136895 0
Academy of Physical Education in Katowice, ul. Mikolowska 72A, 40-065 Katowice
Country 136895 0
Poland
Phone 136895 0
+48322075152
Fax 136895 0
Email 136895 0
s.bankowski@awf.katowice.pl
Contact person for scientific queries
Name 136896 0
Ewa Sadowska-Krepa
Address 136896 0
Academy of Physical Education in Katowice, ul. Mikolowska 72A, 40-065 Katowice
Country 136896 0
Poland
Phone 136896 0
+48322075471
Fax 136896 0
Email 136896 0
e.sadowska-krepa@awf.katowice.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.