NCT01837303

chemQbiosciences:Manual Liquid Based Cytology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cervical Dysplasia
• Cervical Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-04-23
• Last updated: 2013-12-04

Locations

1 site across 1 country: United States