Squamous Cell Carcinoma Antigen Analysis at the University Hospital Ostrava

April 4, 2013 updated by: University Hospital Ostrava

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czech Republic, 70800
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical removal of sinonasal papiloma
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.
Device: Surgical removal of sinonasal papiloma
An endoscopic endonasal surgical device is used to remove the sinonasal papilomas in the study subjects.
Other Names:
  • endoscopic endonasal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood levels of SCCA at six months after surgical removal of sinonasal papiloma
Time Frame: 11 years
The levels of SCCA were assessed at six months after the surgical procedure and every six months during the follow-up period.
11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Study Director: Pavel Kominek, doc.MD,PhD,MBA, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 9, 2013

Study Record Updates

Last Update Posted (Estimate)

April 9, 2013

Last Update Submitted That Met QC Criteria

April 4, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-ENT-SCCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Papilloma

Clinical Trials on Surgical removal of sinonasal papiloma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe