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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
fishman ami, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01584414
First received: April 22, 2012
Last updated: April 24, 2012
Last verified: April 2012
  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 Meir Medical Center:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014