chemQbiosciences:Manual Liquid Based Cytology

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01837303

Enrollment

Registered

2013-04-23

Start date

2013-05-31

Completion date

2013-09-30

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Dysplasia, Cervical Cancer

Keywords

Cervical dysplasia, Cervical cancer

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.

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.

Interventions

PROCEDUREPap 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.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Compare cytologic outcomes using manual liquid based cytology to conventional	4 months	A single board certified Pathologist will blindly review the study pap smear and clinical pap smear. There results will be compared for differences.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026