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NCT01837303 Clinical Trial

chemQbiosciences:Manual Liquid Based Cytology

Cervical Cancer Clinical Trial

Official title:
chemQbiosciences:Manual Liquid Based Cytology

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01837303
Other study ID # 13-1341
Secondary ID
Status Completed
Phase N/A
First received April 8, 2013
Last updated December 3, 2013
Start date May 2013
Est. completion date September 2013

Study information
Verified date April 2013
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. Clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based cytology.

Description:

Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. The study pap medium will be processed using the manufacturers instructions and then clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female ages 18 years or older

- English speaking

- Presenting for pap smear examination

Exclusion Criteria:

- Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Procedure:
• Pap smear
A pap smear/cervical cytology is performed using a spatula and brush to obtain cells from the ectocervical and endocervical region of the cervix. The specimen will be collected twice to put in the standard clinical pap medium and another to put in the study pap medium. These slides will be processed so that they may be reviewed by a single board certified pathologist. There are no other interventions or follow up. All participants will undergo the above described procedures. There is no placebo.

Locations
Country Name City State
United States University of North Carolina Hospitals Chapel Hill North Carolina

Sponsors (1)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare cytologic outcomes using manual liquid based cytology to conventional A single board certified Pathologist will blindly review the study pap smear and clinical pap smear. There results will be compared for differences. 4 months No
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