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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01584414
First Posted: April 25, 2012
Last Update Posted: April 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
fishman ami, Meir Medical Center
  Purpose
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.

Condition Phase
Cervical Cancer Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer

Resource links provided by NLM:


Further study details as provided by fishman ami, Meir Medical Center:

Enrollment: 210
Study Start Date: October 2007
Study Completion Date: April 2010
Groups/Cohorts
normal samples
premalignant/carcinoma samples

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584414


Locations
Israel
Meir Medical Center
Kfar - Sava, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Ami Fishman, Prof Meir medical Center, affiliated with Sackler School of Medicine, Tel-Aviv University
  More Information

Responsible Party: fishman ami, Ami Fishman, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01584414     History of Changes
Other Study ID Numbers: ZT-CL-01A
First Submitted: April 22, 2012
First Posted: April 25, 2012
Last Update Posted: April 25, 2012
Last Verified: April 2012

Keywords provided by fishman ami, 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