Squamous Cell Carcinoma Antigen Analysis at the University Hospital Ostrava
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 22, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedApril 9, 2013
April 1, 2013
11.9 years
March 22, 2013
April 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Changes in blood levels of SCCA at six months after surgical removal of sinonasal papiloma
11 years
Study Arms (1)
Surgical removal of sinonasal papiloma
EXPERIMENTALThe study group consisted of patients following a surgical removal of sinonasal papiloma, in which the SCCA blood levels were assessed in pre-defined intervals.
Interventions
An endoscopic endonasal surgical device is used to remove the sinonasal papilomas in the study subjects.
Eligibility Criteria
You may qualify if:
- at least three-year follow-up following the surgical procedure
- signed Informed Consent
You may not qualify if:
- patient lost during follow-up
- patients in critical condition (ASA IV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70800, Czechia
Related Publications (2)
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.
PMID: 11815971BACKGROUNDFan 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.
PMID: 16871944BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pavel Kominek, doc.MD,PhD,MBA
University Hospital Ostrava
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2013
First Posted
April 9, 2013
Study Start
January 1, 2000
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
April 9, 2013
Record last verified: 2013-04