Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique. - Full Text View

Purpose

A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared to the FDA-approved spatula/cytobrush when used as the cell collection device in screening for cervical cancer.

The InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector

Condition	Intervention
Colposcopy Biopsy	Device: e2 Cell Collector [SoftPAP(R)] Device: Spatula/Brush

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Clinical Study Validating the Adequacy, Efficacy, and Safety of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique In Patients With Recent History of Abnormal Pap Test Returning for Colposcopy/Biopsy.

Further study details as provided by CytoCore, Inc.:

Primary Outcome Measures:

Cell Collection Efficacy [ Time Frame: At the time of cell collection. ] [ Designated as safety issue: Yes ]
Specimen Adequacy [ Time Frame: At time of cell collection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Human Papilloma Virus (HPV) Detection Frequency [ Time Frame: At the time of cell collection. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Cervical cells

Enrollment:	737
Study Start Date:	April 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Arm 1 - Experimental e2 Cell Collector [SoftPAP(R)]	Device: e2 Cell Collector [SoftPAP(R)] Cervical cells collected using the e2 Cell Collector [SoftPAP(R)]
Arm 2 - Control Brush/spatula	Device: Spatula/Brush Cervical cells collected using a combination of a cervical spatula and an endocervical brush

Detailed Description:

The e2TM (SoftPAP) Collector collects only cells that have been exfoliated from the cervix whereas spatulas, brushes and broom-style collection devices collect cells by scraping or abrading the cervix. THis trial is to determine whether the purely exfoliated sample collected using the e2TM Collector is equivalent to samples obtained by scraping or abrading the cervix for purposes of cervical cancer screening and HPV detection.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women > 18 years of age with an abnormal pap within 30 days to 1 year for whom a colposcopy is scheduled.

Criteria

Inclusion Criteria:

Women ages 18 years old and above
Women scheduled to undergo colposcopy

Exclusion Criteria:

Patients who have had a hysterectomy
Patients who are pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474968

Locations

United States, Florida
Visions Clinical Research
Wellington, Florida, United States, 33414
Comprehensive Clinical Trials
West Palm Beach, Florida, United States, 33409
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63106
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45206
United States, Pennsylvania
University of Pittsburgh Medical Centers
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor Research Institute
Fort Worth, Texas, United States, 75246
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510

Sponsors and Collaborators

CytoCore, Inc.

University Hospital Case Medical Center

Investigators

Principal Investigator:

Jay S. Pinkerton, MD

University Hospital Case Medical Center

More Information

Publications:

Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27.

Sankaranarayanan R, Budukh AM, Rajkumar R. Effective screening programmes for cervical cancer in low- and middle-income developing countries. Bull World Health Organ. 2001;79(10):954-62. Epub 2001 Nov 1. Review.

Waxman AG. Guidelines for cervical cancer screening: history and scientific rationale. Clin Obstet Gynecol. 2005 Mar;48(1):77-97. Review. No abstract available.

Holowaty P, Miller AB, Rohan T, To T. RESPONSE: re: natural history of dysplasia of the uterine cervix J Natl Cancer Inst. 1999 Aug 18;91(16):1420A-1421. No abstract available.

Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T Jr, Young N; Forum Group Members; Bethesda 2001 Workshop. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002 Apr 24;287(16):2114-9. Review.

Nanda K, McCrory DC, Myers ER, Bastian LA, Hasselblad V, Hickey JD, Matchar DB. Accuracy of the Papanicolaou test in screening for and follow-up of cervical cytologic abnormalities: a systematic review. Ann Intern Med. 2000 May 16;132(10):810-9. Review.

Fahey MT, Irwig L, Macaskill P. Meta-analysis of Pap test accuracy. Am J Epidemiol. 1995 Apr 1;141(7):680-9.

Clavel C, Masure M, Bory JP, Putaud I, Mangeonjean C, Lorenzato M, Nazeyrollas P, Gabriel R, Quereux C, Birembaut P. Human papillomavirus testing in primary screening for the detection of high-grade cervical lesions: a study of 7932 women. Br J Cancer. 2001 Jun 15;84(12):1616-23.

Willis BH, Barton P, Pearmain P, Bryan S, Hyde C. Cervical screening programmes: can automation help? Evidence from systematic reviews, an economic analysis and a simulation modelling exercise applied to the UK. Health Technol Assess. 2005 Mar;9(13):1-207, iii. Review.

Buntinx F, Brouwers M. Relation between sampling device and detection of abnormality in cervical smears: a meta-analysis of randomised and quasi-randomised studies. BMJ. 1996 Nov 23;313(7068):1285-90.

Martin-Hirsch P, Lilford R, Jarvis G, Kitchener HC. Efficacy of cervical-smear collection devices: a systematic review and meta-analysis. Lancet. 1999 Nov 20;354(9192):1763-70. Erratum in: Lancet 2000 Jan 29;355(9201):414.

Martin-Hirsch P, Jarvis G, Kitchener H, Lilford R. Collection devices for obtaining cervical cytology samples. Cochrane Database Syst Rev. 2000;(2):CD001036. Review. Update in: Cochrane Database Syst Rev. 2000;(3):CD001036.

Selvaggi SM, Guidos BJ. Specimen adequacy and the ThinPrep Pap Test: the endocervical component. Diagn Cytopathol. 2000 Jul;23(1):23-6.

Marchand L, Mundt M, Klein G, Agarwal SC. Optimal collection technique and devices for a quality pap smear. WMJ. 2005 Aug;104(6):51-5.

Koss LG. Evolution in cervical pathology and cytology: a historical perspective. Eur J Gynaecol Oncol. 2000;21(6):550-4. No abstract available.

Responsible Party:	Richard Domanik, CytoCore
ClinicalTrials.gov Identifier:	NCT00474968 History of Changes
Other Study ID Numbers:	e2TM Cervical cell Collector
Study First Received:	May 16, 2007
Results First Received:	May 4, 2009
Last Updated:	November 16, 2009
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013