ColposcopyNCT00474968

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

An observational study of Colposcopy and Biopsy, run by CytoCore, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Colposcopy, Biopsy
What is being tested?: e2 Cell Collector [SoftPAP(R)] and Spatula/Brush
Type of treatment: Medical device
How many people: 737 participants
Where: 7 sitesUnited States
Study dates: Apr 2007to May 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Patients who have had a hysterectomy
Patients who are pregnant.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

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

Other trials in United States

About this study

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.

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

Read the 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.

Conditions: Colposcopy, Biopsy
Being tested: e2 Cell Collector [SoftPAP(R)], Spatula/Brush

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00474968
Study group	Role	What they receive
Arm 1 - Experimental		e2 Cell Collector [SoftPAP(R)] Receives: Device: e2 Cell Collector [SoftPAP(R)]
Arm 2 - Control		Brush/spatula Receives: Device: Spatula/Brush

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At the time of cell collection.
Specimen Adequacy
Number and percentage of samples classified as adequate for diagnosis
Measured: At time of cell collection

Secondary outcomes (1)

Human Papilloma Virus (HPV) Detection Frequency
Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay
Measured: At the time of cell collection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007May 2008

First posted17 May 2007 (estimated)
Study startApr 2007
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for ColposcopyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 737 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00474968
Sponsor's protocol ID: e2TM Cervical cell Collector
Status last verified: Nov 2009
First submitted: 16 May 2007
Last updated: 20 Nov 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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. doi: 10.1056/NEJMoa021641.
PubMed 12571259
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.
PubMed 11693978
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.
PubMed 15725861
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.
PubMed 10451450
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.
PubMed 11966386
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.
PubMed 10819705
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.
PubMed 7702044
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.
PubMed 11401314
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.
PubMed 15774236
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.
PubMed 8942687
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.
PubMed 10577637
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.
PubMed 10796736
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.
PubMed 10907927
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.
PubMed 16218317
Koss LG. Evolution in cervical pathology and cytology: a historical perspective. Eur J Gynaecol Oncol. 2000;21(6):550-4. No abstract available.
PubMed 11214608

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit
Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms
RecruitingObservational study
Vaginal Wall Retraction Using VuSleeve
Adult Females
Not yet recruiting
Embodied Conversational Agents for CervicalCancer Screening Abnormalities
Cervical Cancer Screening
Recruiting
Improving Diagnostics in Cervical Dysplasia
Cervical Cancer
Not yet recruitingObservational study
VIA Versus Colposcopy
Cervical Intraepithelial Neoplasia (CIN), Cervicitis

All Colposcopy trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00474968
Acronym / sponsor ID: e2TM Cervical cell Collector
Conditions: Colposcopy, Biopsy
Study type: Observational
Recruitment status: Completed
Enrolment: 737 participants (actual)
Lead sponsor: CytoCore, Inc.Industry (pharma, biotech, devices)
Collaborators: University Hospitals Cleveland Medical Center
Study start: Apr 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 17 May 2007 (estimated)
Results: Posted 13 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Arm 1 - Experimental	–	Device: e2 Cell Collector [SoftPAP(R)]e2 Cell Collector [SoftPAP(R)]
Arm 2 - Control	–	Device: Spatula/BrushBrush/spatula

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Women > 18 years of age with an abnormal pap within 30 days to 1 year for whom a colposcopy is scheduled.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

Patients who have had a hysterectomy
Patients who are pregnant.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
e2 Cell Collector [SoftPAP(R)]Cervical cells collected using the e2 Cell Collector [SoftPAP(R)]	Device	Arm 1 - Experimental
Spatula/BrushCervical cells collected using a combination of a cervical spatula and an endocervical brush	Device	Arm 2 - Control

Primary outcome

Cell Collection Efficacy
Time frame: At the time of cell collection.
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.
Specimen Adequacy
Time frame: At time of cell collection
Number and percentage of samples classified as adequate for diagnosis

1 secondary outcome

Human Papilloma Virus (HPV) Detection Frequency
Time frame: At the time of cell collection.

Results and safety

Results posted to the registry on 13 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SoftPAP	366	348
Brush/Spatula	371	355

Primary outcome: Cell Collection Efficacy

Time frame: At the time of cell collection.. Number. Unit: Participants

Measure	SoftPAP n = 348	Brush/Spatula n = 355
True Positive (TP) (Cytology Dx vs (Bx + ECC)	174	170
True Negative (TN) (Cytology Dx vs (Bx + ECC))	33	14
False Positive (FP) (Cytology Dx vs (Bx + ECC))	42	63
False Negative (FN) (Cytology Dx vs (Bx + ECC))	20	27
Excluded - Bx/ECC results not reported	79	81

Population analysed: 79/348 (Arm 1) and 81/355 (Arm 2) participants were excluded from the sensitivity/specificity analysis due to biopsy (Bx) and/or endocervical curettage (ECC) results not being reported

Primary outcome: Specimen Adequacy

Time frame: At time of cell collection. Number. Unit: Participants

Measure	SoftPAP n = 348	Brush/Spatula n = 355
Satisfactory for Diagnosis	343	352
Unsatisfactory for Diagnosis	4	2
Excluded - Slide Preparation Error	1	1

Population analysed: Includes all cytology specimens

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SoftPAP	0 of 348 (0%)	0 of 348 (0%)	Not reported
Brush/Spatula	0 of 355 (0%)	0 of 355 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12571259Munoz 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.
Background: PubMed 11693978Sankaranarayanan 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.
Background: PubMed 15725861Waxman 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.
Background: PubMed 10451450Holowaty 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.
Background: PubMed 11966386Solomon 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.
Background: PubMed 10819705Nanda 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.
Background: PubMed 7702044Fahey 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.
Background: PubMed 11401314Clavel 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.
Background: PubMed 15774236Willis 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.
Background: PubMed 8942687Buntinx 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.
Background: PubMed 10577637Martin-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.
Background: PubMed 10796736Martin-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.

Related trials for Colposcopy

Not yet recruitingObservational study
Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit
Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms
RecruitingObservational study
Vaginal Wall Retraction Using VuSleeve
Adult Females
Not yet recruiting
Embodied Conversational Agents for CervicalCancer Screening Abnormalities
Cervical Cancer Screening
Recruiting
Improving Diagnostics in Cervical Dysplasia
Cervical Cancer
Not yet recruitingObservational study
VIA Versus Colposcopy
Cervical Intraepithelial Neoplasia (CIN), Cervicitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jay S. Pinkerton, MD principal investigator

University Hospitals Cleveland Medical Center

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Colposcopy and Biopsy, run by CytoCore, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cell Collection Efficacy (time frame: At the time of cell collection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00474968, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2009.