Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer
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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.
Study Type: | Observational |
Study Design: | Time Perspective: Prospective |
Official Title: | Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer |
Enrollment: | 210 |
Study Start Date: | October 2007 |
Study Completion Date: | April 2010 |
Groups/Cohorts |
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normal samples |
premalignant/carcinoma samples |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
60 archival cervical biopsy cases with the following diagnoses: normal, 22 cases; CIN-2/3, 18 cases; squamous cell carcinoma, 20 cases.
Inclusion Criteria:
- FEMALE SUBJECT BETWEEN 18 AND 75 YEARS OF AGE.
- ABILITY TO PROVIDE INFORMED CONSENT
Exclusion Criteria:
- SUBJECT WITH KNOWN PREGNANCY AT TIME OF SCREENING.
- PREVIOUS HISTORY OF HYSTERECTOMY
- PARTICIPATION IN ANOTHER CLINICAL TRIAL WITHIN LAST 30 DAYS.
Israel | |
Meir Medical Center | |
Kfar - Sava, Israel |
Principal Investigator: | Ami Fishman, Prof | Meir medical Center, affiliated with Sackler School of Medicine, Tel-Aviv University |
No publications provided
Responsible Party: | fishman ami, Ami Fishman, Meir Medical Center |
ClinicalTrials.gov Identifier: | NCT01584414 History of Changes |
Other Study ID Numbers: | ZT-CL-01A |
Study First Received: | April 22, 2012 |
Last Updated: | April 24, 2012 |
Health Authority: | Israel: The Israel National Institute for Health Policy Research and Health Services Research |
Keywords provided by Meir Medical Center:
Zetiq CellDetect ® stain distinct red/purple color to the cytoplasm of neoplastic distinguishes green/blue stained non-neoplastic cells and tissues |
Additional relevant MeSH terms:
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on October 17, 2012