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

April 24, 2012 updated by: fishman ami, Meir Medical Center
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar - Sava, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

60 archival cervical biopsy cases with the following diagnoses: normal, 22 cases; CIN-2/3, 18 cases; squamous cell carcinoma, 20 cases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
normal samples
premalignant/carcinoma samples

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Ami Fishman, Prof, Meir medical Center, affiliated with Sackler School of Medicine, Tel-Aviv University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 22, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZT-CL-01A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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