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

NCT00474968 | Completed Results DMC

• 1 other identifier: e2TM Cervical cell Collector
• Study Type: observational
• Target: 737
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Colposcopy; Biopsy

Outcome Measures

Primary Outcomes (2)

• Cell Collection Efficacy

  True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.

  At the time of cell collection.

• Specimen Adequacy

  Number and percentage of samples classified as adequate for diagnosis

  At time of cell collection

Secondary Outcomes (1)

• Human Papilloma Virus (HPV) Detection Frequency

  At the time of cell collection.

Study Arms (2)

Arm 1 - Experimental

e2 Cell Collector \[SoftPAP(R)\]

Device: e2 Cell Collector [SoftPAP(R)]

Arm 2 - Control

Brush/spatula

Device: Spatula/Brush

Interventions

e2 Cell Collector [SoftPAP(R)] DEVICE

Cervical cells collected using the e2 Cell Collector \[SoftPAP(R)\]

Arm 1 - Experimental

Spatula/Brush DEVICE

Cervical cells collected using a combination of a cervical spatula and an endocervical brush

Arm 2 - Control

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

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

You may qualify if:

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

You may not qualify if:

• Patients who have had a hysterectomy
• Patients who are pregnant.

Sponsors & Collaborators

• CytoCore, Inc.: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (7)

Visions Clinical Research

Wellington, Florida, 33414, United States

Location

Comprehensive Clinical Trials

West Palm Beach, Florida, 33409, United States

Location

St. Louis University

St Louis, Missouri, 63106, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45206, United States

Location

University of Pittsburgh Medical Centers

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor Research Institute

Fort Worth, Texas, 75246, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

Related Publications (15)

• 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. doi: 10.1056/NEJMoa021641.

  PMID: 12571259 BACKGROUND

• 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.

  PMID: 11693978 BACKGROUND

• Waxman AG. Guidelines for cervical cancer screening: history and scientific rationale. Clin Obstet Gynecol. 2005 Mar;48(1):77-97. doi: 10.1097/01.grf.0000151590.08451.26. No abstract available.

  PMID: 15725861 BACKGROUND

• 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. doi: 10.1093/jnci/91.16.1420a. No abstract available.

  PMID: 10451450 BACKGROUND

• 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. doi: 10.1001/jama.287.16.2114.

  PMID: 11966386 BACKGROUND

• 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. doi: 10.7326/0003-4819-132-10-200005160-00009.

  PMID: 10819705 BACKGROUND

• Fahey MT, Irwig L, Macaskill P. Meta-analysis of Pap test accuracy. Am J Epidemiol. 1995 Apr 1;141(7):680-9. doi: 10.1093/oxfordjournals.aje.a117485.

  PMID: 7702044 BACKGROUND

• 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. doi: 10.1054/bjoc.2001.1845.

  PMID: 11401314 BACKGROUND

• 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. doi: 10.3310/hta9130.

  PMID: 15774236 BACKGROUND

• 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. doi: 10.1136/bmj.313.7068.1285.

  PMID: 8942687 BACKGROUND

• 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. doi: 10.1016/s0140-6736(99)02353-3.

  PMID: 10577637 BACKGROUND

• Martin-Hirsch P, Jarvis G, Kitchener H, Lilford R. Collection devices for obtaining cervical cytology samples. Cochrane Database Syst Rev. 2000;2000(2):CD001036. doi: 10.1002/14651858.CD001036.

  PMID: 10796736 BACKGROUND

• Selvaggi SM, Guidos BJ. Specimen adequacy and the ThinPrep Pap Test: the endocervical component. Diagn Cytopathol. 2000 Jul;23(1):23-6. doi: 10.1002/1097-0339(200007)23:13.0.CO;2-K.

  PMID: 10907927 BACKGROUND

• 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.

  PMID: 16218317 BACKGROUND

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

  PMID: 11214608 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Cervical cells

MeSH Terms

Interventions

Toothbrushing

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Results Point of Contact

• Title: Richard Domanik, Ph.D.
• Organization: CytoCore, Inc.

rdomanik@cytocoreinc.com

312-222-9550

Study Officials

• Jay S. Pinkerton, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 20, 2009
• Results First Posted: August 13, 2009

Record last verified: 2009-11

Locations

US (7)