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NCT01584414 Clinical Trial

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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01584414
Other study ID # ZT-CL-01A
Secondary ID
Status Completed
Phase Phase 1
First received April 22, 2012
Last updated April 24, 2012
Start date October 2007
Est. completion date April 2010

Study information
Verified date April 2012
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date April 2010
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Meir Medical Center Kfar - Sava

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

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