Nasal Polyps Clinical Trial
Official title:
Squamous Cell Carcinoma Antigen as a Marker of Sinonasal Inverted Papilloma
Verified date | April 2013 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | Czech Republic: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Czech Republic | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czech Republic,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 week | No |
Secondary | 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. | 11 years | No |
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