Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer

Clalit Health Services

Status: Completed

Conditions: Cervical Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01584414

ZT-CL-01A

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. FEMALE SUBJECT BETWEEN 18 AND 75 YEARS OF AGE.
2. ABILITY TO PROVIDE INFORMED CONSENT

Exclusion criteria

1. SUBJECT WITH KNOWN PREGNANCY AT TIME OF SCREENING.
2. PREVIOUS HISTORY OF HYSTERECTOMY
3. PARTICIPATION IN ANOTHER CLINICAL TRIAL WITHIN LAST 30 DAYS.

Trial design

210 participants in 2 patient groups

normal samples

premalignant/carcinoma samples