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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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normal samples

No interventions assigned to this group

premalignant/carcinoma samples

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes