Salivary Gland TumorNCT06034782
Diagnostic Accuracy of Fine Needle Aspiration in Patients With Salivary Gland Tumors.
An observational study of Salivary Gland Tumor and Diagnosis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Tumors of the salivary glands occupy 0.5-1.2% of cases of head and neck tumors. They are primarily a surgical disease, as their treatment is basically the surgical excision. In this direction and in the context of the differential preoperative diagnosis, in addition to the imaging methods, the fine needle biopsy (FNA)… Read more about this study
- Who is it for?
- Ages 24 to 96 years
- Conditions the study is for
- Salivary Gland Tumor, Diagnosis
- What is being tested?
- Fine Needle Aspiration and Histologic Examination
- Type of treatment
- Surgery or procedure
- How many people
- 128 participants
- Where
- 1 siteGreece
- Study dates
- 22 Feb 2021to 6 Jun 2022
- How long will I take part?
- 1 Year
- 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 24 to 96 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with salivary tumors that examined in outpatient Oral and Maxillofacial Surgery Clinic of Anti-Cancer Hospital of Thessaloniki "Theageneio" and General Hospital of Thessaloniki "G. Papanikolaou".
Who may be able to join
- Adult patients >=18 years
- salivary tumor suspected
- FNA result available
- Salivary tumor surgically resected
- Histologic result available
Who cannot join
- Patients under 18 years old
- FNA result or Histologic result not available
- No tumor resection
- Other neck tumors (not salivary tumor)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Fine Needle Aspiration in Patients With Salivary Gland Tumors,a Retrospective Study
Tumors of the salivary glands occupy 0.5-1.2% of cases of head and neck tumors. They are primarily a surgical disease, as their treatment is basically the surgical excision. In this direction and in the context of the differential preoperative diagnosis, in addition to the imaging methods, the fine needle biopsy (FNA) was used, with which cell material is aspirated from the tumor and studied under the microscope. Although an increasing number of papers have been published in the international scientific literature over the last 5 years on the diagnostic accuracy of FNA in salivary glands, many of them are unable to quantify and omit to refer information that could affect the estimated diagnostic accuracy. Such information is for instance the clinical experience of the doctor who performs the FNA and of the one who assess the smear. The aim of this retrospective study is to evaluate the diagnostic accuracy of fine needle biopsy in adult patients with salivary gland tumor that underwent a surgical excision in two Oral and Maxillofacial Departments in Northern Greece.
The present retrospective study was carried out from 2/2021 to 4/2022 by collecting data from the files of patients who underwent surgery at the Oral and Maxillofacial Clinic of the Theageneio Cancer Hospital of Thessaloniki 1996-2022 and the General Hospital of Thessaloniki G. Papanikolaou 2015-2022. The study was conducted according to the STARD 2015 protocol.
FNA contributed significantly to the differential preoperative process in salivary gland diseases. The differential diagnosis of a lesion in benign / malignant preoperatively, with the use of FNA, enables the surgeon for a more beneficial to the patient and oncologically safer planning of the surgery. It is considered important the high sensitivity provided by the examination, as it helps to exclude with sufficient safety the possible malignancy of the tumor located in the salivary gland of the patient.
Read the detailed description
This retrospective study was conducted according to the STARD 2015 protocol. A thorough retrospective analysis of patient data that were extracted from patient records of a tertiary referral hospital database was performed. The patient files which were included in the study are electronically archived at the Departments of Oral and Maxillofacial Surgery of "Theageneio Anti-Cancer Hospital of Thessaloniki" and of General Hospital of Thessaloniki "George Papanikolaou".
Patients who were included in the present study, except for clinical examination by an Oral and Maxillofacial Surgeon, also underwent at least one imaging modality (MRI, CT scan, ultrasound scan).
This retrospective study was carried out from 2/2021 to 4/2022. Data from records of patients who underwent salivary tumour surgery at the Oral and Maxillofacial Surgery departments of Theageneio Anti-Cancer Hospital of Thessaloniki 1996-2022 and of the General Hospital of Thessaloniki G. Papanikolaou 2015-2022 were collected.
The surgical treatment of all patients with salivary gland tumors who were examined by a practitioner of the two aforementioned Maxillofacial departments, was based on their chronological attendance at the outpatient clinic, while there was no attempt of grouping of them.
Based on the FNA report, FNA results were categorized as follows: Benign, Malignant, Non-diagnostic, Unavailable result. The same categories were obtained for the reference standard test, which was the histopathological examination of the resected tumor.
The sample size was calculated using the software G power analysis version 3.1.9.6. For α = 0.05 and study strength Power 0.95 a sample size of 102 patients had been obtained which was relatively smaller compared to the 128 patients that were finally included in the study.
During the data collection from the medical patient records, there were 11 (n = 11) out of 139 (n = 139) cases whose FNA result and 4 (n=4) out of 184 (n=184) whose histological result was non-diagnostic as it was not clearly concluded whether the lesion was benign or malignant. These cases were excluded from the estimation of diagnostic accuracy indicators. Likewise to the non-diagnostic results, were excluded the 145 (n = 145) FNA results that were not available.
To assess the diagnostic accuracy of FNA, a comparative process among FNA and histopathological outcomes was conducted. Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, ROC curve and AUC (Area Under curve) were calculated. Calculations were made using software RStudio Version 1.4.1106 © 2009-2021 RStudio, PBC "Tiger Daylily" (2389bc24, 2021-02-11) for Windows Mozilla/5.0 (Windows NT 10.0; Win64; x64) Apple Web Kit/537.36 (KHTML, like Gecko) Qt Web Engine/5.12.8 Chrome/69.0.3497.128 Safari/537.36.
- Conditions
- Salivary Gland Tumor, Diagnosis
- Being tested
- Fine Needle Aspiration, Histologic Examination
- Keywords
- salivary tumors, diagnostic accuracy, Fine Needle Aspiration
- Medical subject headings
- Salivary Gland Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine Needle AspirationDiagnostic test
Also called FNA
Fine Needle Aspiration of a salivary gland tumor
Histologic ExaminationProcedure or surgery
Histologic examination of resected salivary tumor
| Study group | Role | What they receive |
|---|---|---|
| patients with salivary gland tumors | patients with salivary gland tumors Receives: Diagnostic Test: Fine Needle Aspiration; Procedure: Histologic Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Fine Needle Aspiration in salivary tumors
The result FNA of salivary tumor was compared to (verified) Histologic result after tumor resection. Then Diagnostic accuracy of FNA was estimated.
Measured: Every patient underwent FNA in a time frame from 1 day to 1 month before the surgical resection of the tumor. Then, under general anesthesia the tumor was surgicaly resected and was immediately examined to the Histology Laboratory of the Hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start22 Feb 2021
- Primary completion15 May 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland TumorStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Other
- Time perspective
- Other
- Enrolment
- 128 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodoros V. Grivas, Medical, Principal investigator, Aristotle University Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034782
- Sponsor's protocol ID
- 18/22-02-2021
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: SN,Sex,Clinic of Origin,Date of Birth,Age, Final Result of FNA (as included in Excel database),Histological result (as included in Excel database) are available to all researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Fine Needle Aspiration in Patients With Salivary Gland Tumors,a Retrospective Study
- ClinicalTrials.gov ID
- NCT06034782
- Acronym / sponsor ID
- 18/22-02-2021
- Conditions
- Salivary Gland Tumor, Diagnosis
- Keywords
- salivary tumors, diagnostic accuracy, Fine Needle Aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 13 Sep 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.
Tumors of the salivary glands occupy 0.5-1.2% of cases of head and neck tumors. They are primarily a surgical disease, as their treatment is basically the surgical excision. In this direction and in the context of the differential preoperative diagnosis, in addition to the imaging methods, the fine needle biopsy (FNA) was used, with which cell material is aspirated from the tumor and studied under the microscope. Although an increasing number of papers have been published in the international scientific literature over the last 5 years on the diagnostic accuracy of FNA in salivary glands, many of them are unable to quantify and omit to refer information that could affect the estimated diagnostic accuracy. Such information is for instance the clinical experience of the doctor who performs the FNA and of the one who assess the smear. The aim of this retrospective study is to evaluate the diagnostic accuracy of fine needle biopsy in adult patients with salivary gland tumor that underwent a surgical excision in two Oral and Maxillofacial Departments in Northern Greece.
The present retrospective study was carried out from 2/2021 to 4/2022 by collecting data from the files of patients who underwent surgery at the Oral and Maxillofacial Clinic of the Theageneio Cancer Hospital of Thessaloniki 1996-2022 and the General Hospital of Thessaloniki G. Papanikolaou 2015-2022. The study was conducted according to the STARD 2015 protocol.
FNA contributed significantly to the differential preoperative process in salivary gland diseases. The differential diagnosis of a lesion in benign / malignant preoperatively, with the use of FNA, enables the surgeon for a more beneficial to the patient and oncologically safer planning of the surgery. It is considered important the high sensitivity provided by the examination, as it helps to exclude with sufficient safety the possible malignancy of the tumor located in the salivary gland of the patient.
Detailed description
This retrospective study was conducted according to the STARD 2015 protocol. A thorough retrospective analysis of patient data that were extracted from patient records of a tertiary referral hospital database was performed. The patient files which were included in the study are electronically archived at the Departments of Oral and Maxillofacial Surgery of "Theageneio Anti-Cancer Hospital of Thessaloniki" and of General Hospital of Thessaloniki "George Papanikolaou".
Patients who were included in the present study, except for clinical examination by an Oral and Maxillofacial Surgeon, also underwent at least one imaging modality (MRI, CT scan, ultrasound scan).
This retrospective study was carried out from 2/2021 to 4/2022. Data from records of patients who underwent salivary tumour surgery at the Oral and Maxillofacial Surgery departments of Theageneio Anti-Cancer Hospital of Thessaloniki 1996-2022 and of the General Hospital of Thessaloniki G. Papanikolaou 2015-2022 were collected.
The surgical treatment of all patients with salivary gland tumors who were examined by a practitioner of the two aforementioned Maxillofacial departments, was based on their chronological attendance at the outpatient clinic, while there was no attempt of grouping of them.
Based on the FNA report, FNA results were categorized as follows: Benign, Malignant, Non-diagnostic, Unavailable result. The same categories were obtained for the reference standard test, which was the histopathological examination of the resected tumor.
The sample size was calculated using the software G power analysis version 3.1.9.6. For α = 0.05 and study strength Power 0.95 a sample size of 102 patients had been obtained which was relatively smaller compared to the 128 patients that were finally included in the study.
During the data collection from the medical patient records, there were 11 (n = 11) out of 139 (n = 139) cases whose FNA result and 4 (n=4) out of 184 (n=184) whose histological result was non-diagnostic as it was not clearly concluded whether the lesion was benign or malignant. These cases were excluded from the estimation of diagnostic accuracy indicators. Likewise to the non-diagnostic results, were excluded the 145 (n = 145) FNA results that were not available.
To assess the diagnostic accuracy of FNA, a comparative process among FNA and histopathological outcomes was conducted. Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, ROC curve and AUC (Area Under curve) were calculated. Calculations were made using software RStudio Version 1.4.1106 © 2009-2021 RStudio, PBC "Tiger Daylily" (2389bc24, 2021-02-11) for Windows Mozilla/5.0 (Windows NT 10.0; Win64; x64) Apple Web Kit/537.36 (KHTML, like Gecko) Qt Web Engine/5.12.8 Chrome/69.0.3497.128 Safari/537.36.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with salivary gland tumors | – | Diagnostic Test: Fine Needle Aspiration, Procedure: Histologic Examinationpatients with salivary gland tumors |
Who may qualify
- Ages
- 24 to 96 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with salivary tumors that examined in outpatient Oral and Maxillofacial Surgery Clinic of Anti-Cancer Hospital of Thessaloniki "Theageneio" and General Hospital of Thessaloniki "G. Papanikolaou".
Key inclusion criteria (5 listed)
- Adult patients >=18 years
- salivary tumor suspected
- FNA result available
- Salivary tumor surgically resected
- Histologic result available
Key exclusion criteria (4 listed)
- Patients under 18 years old
- FNA result or Histologic result not available
- No tumor resection
- Other neck tumors (not salivary tumor)
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 |
|---|---|---|
| Fine Needle AspirationAlso: FNAFine Needle Aspiration of a salivary gland tumor | Diagnostic test | patients with salivary gland tumors |
| Histologic ExaminationHistologic examination of resected salivary tumor | Procedure or surgery | patients with salivary gland tumors |
Primary outcome
Diagnostic accuracy of Fine Needle Aspiration in salivary tumors
Time frame: Every patient underwent FNA in a time frame from 1 day to 1 month before the surgical resection of the tumor. Then, under general anesthesia the tumor was surgicaly resected and was immediately examined to the Histology Laboratory of the Hospital.
The result FNA of salivary tumor was compared to (verified) Histologic result after tumor resection. Then Diagnostic accuracy of FNA was estimated.
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 13 Sep 2023.
- Individual participant dataSharing planned: Yes. SN,Sex,Clinic of Origin,Date of Birth,Age, Final Result of FNA (as included in Excel database),Histological result (as included in Excel database) are available to all researchers.
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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.
Theodoros V. Grivas, Medical principal investigator
Aristotle University Thessaloniki
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 Salivary Gland Tumor and Diagnosis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 5 inclusion and 4 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 13 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 Greece. 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?
Diagnostic accuracy of Fine Needle Aspiration in salivary tumors (time frame: Every patient underwent FNA in a time frame from 1 day to 1 month before the surgical resection of the tumor. Then, under general anesthesia the tumor was surgicaly resected and was immediately examined to the Histology Laboratory of the Hospital.). 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 13 Sep 2023.