Squamous Cell Carcinoma Antigen Analysis at the University Hospital Ostrava
Primary Purpose
Nasal Polyps, Nasal Diseases, Papilloma
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Surgical removal of sinonasal papiloma
Sponsored by
About this trial
This is an interventional diagnostic trial for Nasal Polyps focused on measuring squamous cell carcinoma antigen, sinonasal inverted papilloma, clinical marker, hidden reccurence, surgery
Eligibility Criteria
Inclusion Criteria:
- at least three-year follow-up following the surgical procedure
- signed Informed Consent
Exclusion Criteria:
- patient lost during follow-up
- patients in critical condition (ASA IV)
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgical removal of sinonasal papiloma
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01827423
First Posted
March 22, 2013
Last Updated
April 4, 2013
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT01827423
Brief Title
Squamous Cell Carcinoma Antigen Analysis at the University Hospital Ostrava
Official Title
Squamous Cell Carcinoma Antigen as a Marker of Sinonasal Inverted Papilloma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps, Nasal Diseases, Papilloma
Keywords
squamous cell carcinoma antigen, sinonasal inverted papilloma, clinical marker, hidden reccurence, surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgical removal of sinonasal papiloma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Surgical removal of sinonasal papiloma
Other Intervention Name(s)
endoscopic endonasal surgery
Intervention Description
An endoscopic endonasal surgical device is used to remove the sinonasal papilomas in the study subjects.
Primary Outcome Measure Information:
Title
Changes in blood levels of SCCA before and after surgical removal of sinonasal papiloma
Description
The levels of SCCA were assessed before and after the surgical procedure.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Changes in blood levels of SCCA at six months after surgical removal of sinonasal papiloma
Description
The levels of SCCA were assessed at six months after the surgical procedure and every six months during the follow-up period.
Time Frame
11 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least three-year follow-up following the surgical procedure
signed Informed Consent
Exclusion Criteria:
patient lost during follow-up
patients in critical condition (ASA IV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Kominek, doc.MD,PhD,MBA
Organizational Affiliation
University Hospital Ostrava
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70800
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
11815971
Citation
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.
Results Reference
background
PubMed Identifier
16871944
Citation
Fan 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.
Results Reference
background
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Squamous Cell Carcinoma Antigen Analysis at the University Hospital Ostrava
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