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Squamous Cell Carcinoma Antigen as a Marker of Sinonasal Inverted Papilloma

18 Years
Not Enrolling
Nasal Polyps, Nasal Diseases, Papilloma

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Trial Information

Squamous Cell Carcinoma Antigen as a Marker of Sinonasal Inverted Papilloma

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

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.

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)

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Changes in blood levels of SCCA before and after surgical removal of sinonasal papiloma

Outcome Description:

The levels of SCCA were assessed before and after the surgical procedure.

Outcome Time Frame:

1 week

Safety Issue:


Principal Investigator

Pavel Kominek, doc.MD,PhD,MBA

Investigator Role:

Study Director

Investigator Affiliation:

University Hospital Ostrava


Czech Republic: Ethics Committee

Study ID:




Start Date:

January 2000

Completion Date:

January 2012

Related Keywords:

  • Nasal Polyps
  • Nasal Diseases
  • Papilloma
  • squamous cell carcinoma antigen
  • sinonasal inverted papilloma
  • clinical marker
  • hidden reccurence
  • surgery
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Nasal Polyps
  • Nose Diseases
  • Papilloma
  • Papilloma, Inverted