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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01584414

Enrollment

210

Registered

2012-04-25

Start date

2007-10-31

Completion date

2010-04-30

Last updated

2012-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Zetiq CellDetect ® stain, distinct red/purple color to the cytoplasm of neoplastic, distinguishes green/blue stained non-neoplastic cells and tissues

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Countries

Israel

Outcome results