chemQbiosciences:Manual Liquid Based Cytology

NCT01837303 | Completed

• 1 other identifier: 13-1341
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Dysplasia; Cervical Cancer

Keywords

Cervical dysplasia; Cervical cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Liquid based cytology

All participants will undergo both manual and conventional automated liquid based cytology (pap smear, cervical cytology).

Procedure: Pap smear

Interventions

Pap smear PROCEDURE

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.

Also known as: cervical cytology

Liquid based cytology

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

76 healthy women presenting for standard pap smear screening

You may qualify if:

• Female ages 18 years or older
• English speaking
• Presenting for pap smear examination

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Interventions

Papanicolaou Test

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lisa Rahangdale, MD, MPH

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 23, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-04

Locations

US (1)