Head and Neck ParagangliomaNCT05942482
Head and Neck Paragangliomas: A 16-year Experience of a University Hospital in Turkey
An observational study of Head and Neck Paraganglioma, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the head and neck paraganglioma cases treated in Pamukkale University hospital between 2007-2023 and improve our understanding of these cases and contribute to the knowledge surrounding head and neck paragangliomas. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Paraganglioma
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2023to 5 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent head and neck surgeries at Pamukkale University Hospital between 2007 and 2023, resulting in a histopathological diagnosis of paraganglioma
Who may be able to join
- Histopathological diagnosis of carotid paraganglioma
- Histopathological diagnosis of vagal paraganglioma
- Histopathological diagnosis of jugular paraganglioma
- Histopathological diagnosis of tympanic paraganglioma
Who cannot join
- -Inadequate information in files
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to examine the head and neck paraganglioma cases treated in Pamukkale University hospital between 2007-2023 and improve our understanding of these cases and contribute to the knowledge surrounding head and neck paragangliomas.
Read the detailed description
39 patients were selected and analyzed retrospectively. Demographic informations, complaints at the time of admission, radiological examinations, paraganglioma types, stages, postoperative complications, and relapsed cases were recorded.Preoperative staging plays a crucial role in surgical planning and predicting potential intraoperative complications. In such cases, combination therapy alongside surgery may improve treatment outcomes.
- Conditions
- Head and Neck Paraganglioma
- Keywords
- Paraganglioma, glomus
- Medical subject headings
- Paraganglioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative recurrence
Incidence of recurrences after the surgery
Measured: may 2023-june 2023
Postoperative nerve paralysis
Incidence of facial, vagus, hypoglossus, accesorius nerve paralysis after surgery
Measured: may 2023-june 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start30 Jun 2023
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck ParagangliomaStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
- Investigators
- Fazıl N Ardıç, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942482
- Sponsor's protocol ID
- 13
- Status last verified
- Sep 2023
- First submitted
- 30 Jun 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck Paragangliomas: A 16-year Experience of a University Hospital in Turkey
- ClinicalTrials.gov ID
- NCT05942482
- Acronym / sponsor ID
- 13
- Conditions
- Head and Neck Paraganglioma
- Keywords
- Paraganglioma, glomus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 12 Jul 2023 (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 aim of the study is to examine the head and neck paraganglioma cases treated in Pamukkale University hospital between 2007-2023 and improve our understanding of these cases and contribute to the knowledge surrounding head and neck paragangliomas.
Detailed description
39 patients were selected and analyzed retrospectively. Demographic informations, complaints at the time of admission, radiological examinations, paraganglioma types, stages, postoperative complications, and relapsed cases were recorded.Preoperative staging plays a crucial role in surgical planning and predicting potential intraoperative complications. In such cases, combination therapy alongside surgery may improve treatment outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent head and neck surgeries at Pamukkale University Hospital between 2007 and 2023, resulting in a histopathological diagnosis of paraganglioma
Key inclusion criteria (4 listed)
- Histopathological diagnosis of carotid paraganglioma
- Histopathological diagnosis of vagal paraganglioma
- Histopathological diagnosis of jugular paraganglioma
- Histopathological diagnosis of tympanic paraganglioma
Key exclusion criteria (1 listed)
- -Inadequate information in files
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
Postoperative recurrence
Time frame: may 2023-june 2023
Incidence of recurrences after the surgery
Postoperative nerve paralysis
Time frame: may 2023-june 2023
Incidence of facial, vagus, hypoglossus, accesorius nerve paralysis after surgery
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 15 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Fazıl N Ardıç, MD principal investigator
Pamukkale University
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 Head and Neck Paraganglioma, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 4 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 15 Sep 2023. 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 Turkey (Türkiye). 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?
Postoperative recurrence (time frame: may 2023-june 2023). The study lists 2 primary outcomes in all. 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 15 Sep 2023.