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

Biopsy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474968
• Other study ID #: e2TM Cervical cell Collector
• Status: Completed
• Phase: N/A
• First received: May 16, 2007
• Last updated: November 16, 2009
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: November 2009
• Source: CytoCore, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 737
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Biopsy
• Colposcopy

Intervention

Device:
• e2 Cell Collector [SoftPAP(R)]
Cervical cells collected using the e2 Cell Collector [SoftPAP(R)]
• Spatula/Brush
Cervical cells collected using a combination of a cervical spatula and an endocervical brush

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Baylor Research Institute	Fort Worth	Texas
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	University of Pittsburgh Medical Centers	Pittsburgh	Pennsylvania
United States	St. Louis University	St. Louis	Missouri
United States	Visions Clinical Research	Wellington	Florida
United States	Comprehensive Clinical Trials	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
CytoCore, Inc.	University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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

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. — View Citation

Koss LG. Evolution in cervical pathology and cytology: a historical perspective. Eur J Gynaecol Oncol. 2000;21(6):550-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Muñoz N, Bosch FX, de Sanjosé S, Herrero R, Castellsagué 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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Waxman AG. Guidelines for cervical cancer screening: history and scientific rationale. Clin Obstet Gynecol. 2005 Mar;48(1):77-97. Review. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell Collection Efficacy		At the time of cell collection.	Yes
Primary	Specimen Adequacy		At time of cell collection	Yes
Secondary	Human Papilloma Virus (HPV) Detection Frequency		At the time of cell collection.	No