Nasal PolypsNCT01827423
Squamous Cell Carcinoma Antigen Analysis at the University Hospital Ostrava
A study testing Surgical removal of sinonasal papiloma in people with Nasal Polyps and Nasal Diseases, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
This prospective study aimed to evaluate the usefulness of squamous cell carcinoma antigen (SCCA) as a clinical marker of sinonasal inverted papilloma (IP). The potential benefit of SCCA in the diagnosis of unilateral nasal pathology and as a marker of hidden recurrence was evaluated as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps, Nasal Diseases, Papilloma
- What is being tested?
- Surgical removal of sinonasal papiloma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2000to Jan 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least three-year follow-up following the surgical procedure
- signed Informed Consent
Who cannot join
- patient lost during follow-up
- patients in critical condition (ASA IV)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70800
About this study
Official title: Squamous Cell Carcinoma Antigen as a Marker of Sinonasal Inverted Papilloma
This prospective study aimed to evaluate the usefulness of squamous cell carcinoma antigen (SCCA) as a clinical marker of sinonasal inverted papilloma (IP). The potential benefit of SCCA in the diagnosis of unilateral nasal pathology and as a marker of hidden recurrence was evaluated as well.
Blood samples from patients with sinonasal IP were examined to determine serum SCCA levels before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and postoperative levels of SCCA were compared.
Read the detailed description
INTRODUCTION Squamous cell carcinoma antigen (SCCA) is a protein with a strong homology to the family of protease inhibitors known as serpins. SCCAs are cytoplasmic proteins: they are found in normal squamous epithelia, and in elevated levels in the serum of patients with squamous cell carcinomas, especially in cases of uterine cervix carcinoma, lung carcinoma, and head and neck squamous cell carcinoma. SCCA is clinically useful, especially for the staging of uterine cervix carcinoma (risk of lymph node metastasis). It is also a useful marker for monitoring during follow-up and therapy, and increasing SCCA levels may predict carcinoma relapse. Recent studies have shown a close relationship between SCCA and sinonasal inverted papilloma (IP).
IP is a relatively infrequent, benign sinonasal tumour. Careful long-term follow-up after radical surgery is necessary when treating IP, owing to its malignant potential and high recurrence rate. Distinguishing between inflammatory changes and recurrence of IP can sometimes be difficult. The purpose of this study was to determine the benefit of SCCA serum level evaluation in patients with IP.
MATERIAL AND METHODS Study design This prospective study was performed in accordance with the Declaration of Helsinki, the criteria of good clinical practice, and all applicable regulatory requirements. Written informed consent was obtained from all participants before the initiation of any procedure.
Patients with IP treated at the Department of Otolaryngology, Faculty of Medicine, University of Ostrava were included in the study. At least three years of follow-up after surgery was required for inclusion of a patient in the study.
Blood samples from enrolled patients were examined to determine serum SCCA levels before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and postoperative SCCA levels were compared. The changes in SCCA levels during follow-up were evaluated.
Biochemical analysis Serum SCCA levels were assayed using an immunofluorescence assay with monoclonal antibodies (B.R.A.H.M.S SCC KRYPTOR kit, Hennigsdorf, Germany). The normal serum level of SCC antigen is 0-1.5 µg/l.
Statistical analysis Statistical analysis of the correlation between preoperative and postoperative serum SCCA levels was performed using Student's t-test for paired data. Differences with p < 0.05 were considered statistically significant.
- Conditions
- Nasal Polyps, Nasal Diseases, Papilloma
- Being tested
- Surgical removal of sinonasal papiloma
- Keywords
- squamous cell carcinoma antigen, sinonasal inverted papilloma, clinical marker, hidden reccurence, surgery
- Medical subject headings
- Nasal Polyps, Nose Diseases, Papilloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical removal of sinonasal papilomaDevice
Also called endoscopic endonasal surgery
An endoscopic endonasal surgical device is used to remove the sinonasal papilomas in the study subjects.
| Study group | Role | What they receive |
|---|---|---|
| Surgical removal of sinonasal papiloma | Experimental | The study group consisted of patients following a surgical removal of sinonasal papiloma, in which the SCCA blood levels were assessed in pre-defined intervals. Receives: Device: Surgical removal of sinonasal papiloma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood levels of SCCA before and after surgical removal of sinonasal papiloma
The levels of SCCA were assessed before and after the surgical procedure.
Measured: 1 week
Secondary outcomes (1)
Changes in blood levels of SCCA at six months after surgical removal of sinonasal papiloma
The levels of SCCA were assessed at six months after the surgical procedure and every six months during the follow-up period.
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJan 2000
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Kominek, doc.MD,PhD,MBA, Study director, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827423
- Sponsor's protocol ID
- FNO-ENT-SCCA
- Status last verified
- Apr 2013
- First submitted
- 22 Mar 2013
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yasumatsu R, Nakashima T, Kuratomi Y, Hirakawa N, Azuma K, Tomita K, Cataltepe S, Silverman GA, Clayman GL, Komiyama S. Serum squamous cell carcinoma antigen is a useful biologic marker in patients with inverted papillomas of the sinonasal tract. Cancer. 2002 Jan 1;94(1):152-8. doi: 10.1002/cncr.10144.
PubMed 11815971Fan GK, Imanaka M, Yang B, Takenaka H. Characteristics of nasal inverted papilloma and its malignant transformation: a study of cell proliferation and programmed cell death. Am J Rhinol. 2006 May-Jun;20(3):360-3. doi: 10.2500/ajr.2006.20.2851.
PubMed 16871944
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Squamous Cell Carcinoma Antigen as a Marker of Sinonasal Inverted Papilloma
- ClinicalTrials.gov ID
- NCT01827423
- Acronym / sponsor ID
- FNO-ENT-SCCA
- Conditions
- Nasal Polyps, Nasal Diseases, Papilloma
- Keywords
- squamous cell carcinoma antigen, sinonasal inverted papilloma, clinical marker, hidden reccurence, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Apr 2013 (estimated)
- 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.
This prospective study aimed to evaluate the usefulness of squamous cell carcinoma antigen (SCCA) as a clinical marker of sinonasal inverted papilloma (IP). The potential benefit of SCCA in the diagnosis of unilateral nasal pathology and as a marker of hidden recurrence was evaluated as well.
Blood samples from patients with sinonasal IP were examined to determine serum SCCA levels before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and postoperative levels of SCCA were compared.
Detailed description
INTRODUCTION Squamous cell carcinoma antigen (SCCA) is a protein with a strong homology to the family of protease inhibitors known as serpins. SCCAs are cytoplasmic proteins: they are found in normal squamous epithelia, and in elevated levels in the serum of patients with squamous cell carcinomas, especially in cases of uterine cervix carcinoma, lung carcinoma, and head and neck squamous cell carcinoma. SCCA is clinically useful, especially for the staging of uterine cervix carcinoma (risk of lymph node metastasis). It is also a useful marker for monitoring during follow-up and therapy, and increasing SCCA levels may predict carcinoma relapse. Recent studies have shown a close relationship between SCCA and sinonasal inverted papilloma (IP).
IP is a relatively infrequent, benign sinonasal tumour. Careful long-term follow-up after radical surgery is necessary when treating IP, owing to its malignant potential and high recurrence rate. Distinguishing between inflammatory changes and recurrence of IP can sometimes be difficult. The purpose of this study was to determine the benefit of SCCA serum level evaluation in patients with IP.
MATERIAL AND METHODS Study design This prospective study was performed in accordance with the Declaration of Helsinki, the criteria of good clinical practice, and all applicable regulatory requirements. Written informed consent was obtained from all participants before the initiation of any procedure.
Patients with IP treated at the Department of Otolaryngology, Faculty of Medicine, University of Ostrava were included in the study. At least three years of follow-up after surgery was required for inclusion of a patient in the study.
Blood samples from enrolled patients were examined to determine serum SCCA levels before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and postoperative SCCA levels were compared. The changes in SCCA levels during follow-up were evaluated.
Biochemical analysis Serum SCCA levels were assayed using an immunofluorescence assay with monoclonal antibodies (B.R.A.H.M.S SCC KRYPTOR kit, Hennigsdorf, Germany). The normal serum level of SCC antigen is 0-1.5 µg/l.
Statistical analysis Statistical analysis of the correlation between preoperative and postoperative serum SCCA levels was performed using Student's t-test for paired data. Differences with p < 0.05 were considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical removal of sinonasal papiloma | Experimental | Device: Surgical removal of sinonasal papilomaThe study group consisted of patients following a surgical removal of sinonasal papiloma, in which the SCCA blood levels were assessed in pre-defined intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least three-year follow-up following the surgical procedure
- signed Informed Consent
Key exclusion criteria (2 listed)
- patient lost during follow-up
- patients in critical condition (ASA IV)
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 |
|---|---|---|
| Surgical removal of sinonasal papilomaAlso: endoscopic endonasal surgeryAn endoscopic endonasal surgical device is used to remove the sinonasal papilomas in the study subjects. | Device | Surgical removal of sinonasal papiloma |
Primary outcome
Changes in blood levels of SCCA before and after surgical removal of sinonasal papiloma
Time frame: 1 week
The levels of SCCA were assessed before and after the surgical procedure.
1 secondary outcome
Changes in blood levels of SCCA at six months after surgical removal of sinonasal papiloma
Time frame: 11 years
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 9 Apr 2013.
- Background: PubMed 11815971Yasumatsu R, Nakashima T, Kuratomi Y, Hirakawa N, Azuma K, Tomita K, Cataltepe S, Silverman GA, Clayman GL, Komiyama S. Serum squamous cell carcinoma antigen is a useful biologic marker in patients with inverted papillomas of the sinonasal tract. Cancer. 2002 Jan 1;94(1):152-8. doi: 10.1002/cncr.10144.
- Background: PubMed 16871944Fan GK, Imanaka M, Yang B, Takenaka H. Characteristics of nasal inverted papilloma and its malignant transformation: a study of cell proliferation and programmed cell death. Am J Rhinol. 2006 May-Jun;20(3):360-3. doi: 10.2500/ajr.2006.20.2851.
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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.
Pavel Kominek, doc.MD,PhD,MBA study director
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical removal of sinonasal papiloma in people with Nasal Polyps and Nasal Diseases, run by University Hospital Ostrava at 1 site in Czechia.
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 2 inclusion and 2 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 9 Apr 2013. 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 Czechia. 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?
Changes in blood levels of SCCA before and after surgical removal of sinonasal papiloma (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01827423, which also lists 2 linked publications.
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 9 Apr 2013.