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.
Verified date | November 2009 |
Source | CytoCore, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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
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. |
Observational Model: Case Control, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
CytoCore, Inc. | University Hospital Case Medical Center |
United States,
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
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 |
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