Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer
- Conditions
- Cervical Cancer
- Registration Number
- NCT01584414
- Lead Sponsor
- Meir Medical Center
- Brief Summary
Zetiq has introduced a histochemical stain that claims to tinctorially identify cancer and neoplastic cells. Because of the potential importance of such a capability, the investigators undertook to investigate Zetiq's CellDetect® staining technology as applied to cultured cell lines as well as an initial sample of clinical cases. This goal was pursued by investigating four types of comparisons: 1) cancer cell lines before and after differentiation; 2) cervical squamous-cell carcinoma (SCC) biopsies to non-neoplastic squamous epithelium; 3) SCCs to neoplastic, nonmalignant squamous epithelium; and 4) neoplastic squamous cells to non-neoplastic squamous cells in cytological preparations. The clinical material was also stained with hematoxylin and eosin (biopsies) or Pap (cytologies) for diagnostic purposes. The investigators found that all CellDetect®-stained cells exhibited one of the two tinctorial outcomes. Cell lines with malignant phenotype uniformly had red/purple cytoplasm, whereas the differentiated phenotype changed the color to blue/green.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 210
- FEMALE SUBJECT BETWEEN 18 AND 75 YEARS OF AGE.
- ABILITY TO PROVIDE INFORMED CONSENT
- SUBJECT WITH KNOWN PREGNANCY AT TIME OF SCREENING.
- PREVIOUS HISTORY OF HYSTERECTOMY
- PARTICIPATION IN ANOTHER CLINICAL TRIAL WITHIN LAST 30 DAYS.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Meir Medical Center
🇮🇱Kfar - Sava, Israel