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Clinical Trials/NCT01827423
NCT01827423CompletedNot Applicable

Squamous Cell Carcinoma Antigen as a Marker of Sinonasal Inverted Papilloma

University Hospital Ostrava2 sites in 2 countries20 target enrollmentStarted: January 1, 2000Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
Changes in blood levels of SCCA before and after surgical removal of sinonasal papiloma

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

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.

Intervention: Surgical removal of sinonasal papiloma (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes in blood levels of SCCA at six months after surgical removal of sinonasal papiloma(11 years)

Investigators

Sponsor
University Hospital Ostrava
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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