Cervical Cell CollectionNCT00496314
Physician's Comfort Level and Satisfaction Study With The e2TM Collector Compared to the Spatula/CytoBrush Technique
An observational study of Cervical Cell Collection, run by CytoCore, Inc. at 1 site in United States.
Trial summary
A study which assesses the physician's comfort level and satisfaction when using the e2TM Collector compared to the Spatula/SytoBrush technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Cell Collection
- What is being tested?
- e2TM Cervical Cell Collector
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Every Physician who will participate in the two CytoCore prospective studies assessing the safety and efficacy of the e2TM Collector
- Each physician will have used the Collector 15 - 25 times
- Each physician will have signed the Consent form prior to using the Collector for the first time.
Who cannot join
- None (commensurate with the above inclusion conditions.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital CASE Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Clinical Study Assessing Physician's Comfort Level and Satisfaction When Using The e2TM Cervical Cell Collector Compared to the Standard Spatula/CytoBrush Technique
A study which assesses the physician's comfort level and satisfaction when using the e2TM Collector compared to the Spatula/SytoBrush technique.
- Conditions
- Cervical Cell Collection
- Being tested
- e2TM Cervical Cell Collector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e2TM Cervical Cell CollectorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician comfort level and satisfaction when using the e2TM Collector compared to the standard spatula/cytobrush.
Measured: Each physician will be surveyed after first and last use of the e2TM collector as well as three more times spaced at near regular intervals in between.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startMay 2007
- Study completionJan 2008
Why it stopped: Terminated for lack of resources to complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cervical Cell CollectionStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytoCore, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center
- Investigators
- Jay Pinkerton, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496314
- Sponsor's protocol ID
- 12-20-06
- Status last verified
- Jun 2008
- First submitted
- 2 Jul 2007
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
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 12571259Sankaranarayanan 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 11693978Umland B, Waterman R, Wiese W, Duban S, Mennin S, Kaufman A. Learning from a rural physician program in China. Acad Med. 1992 May;67(5):307-9. doi: 10.1097/00001888-199205000-00004. No abstract available.
PubMed 1575861Holowaty 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 10451450Solomon 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 11966386Nanda 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 10819705Fahey 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 7702044Clavel 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 11401314Willis 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 15774236Buntinx 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 8942687Martin-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 10577637Martin-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 10796736Selvaggi 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 10907927Marchand 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 16218317Koss LG. Evolution in cervical pathology and cytology: a historical perspective. Eur J Gynaecol Oncol. 2000;21(6):550-4. No abstract available.
PubMed 11214608
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Assessing Physician's Comfort Level and Satisfaction When Using The e2TM Cervical Cell Collector Compared to the Standard Spatula/CytoBrush Technique
- ClinicalTrials.gov ID
- NCT00496314
- Acronym / sponsor ID
- 12-20-06
- Conditions
- Cervical Cell Collection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated for lack of resources to complete.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CytoCore, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- May 2007
- Study completion
- Jan 2008 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study which assesses the physician's comfort level and satisfaction when using the e2TM Collector compared to the Spatula/SytoBrush technique.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Every Physician who will participate in the two CytoCore prospective studies assessing the safety and efficacy of the e2TM Collector
- Each physician will have used the Collector 15 - 25 times
- Each physician will have signed the Consent form prior to using the Collector for the first time.
Key exclusion criteria (1 listed)
- None (commensurate with the above inclusion conditions.)
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 |
|---|---|---|
| e2TM Cervical Cell Collector | Device | – |
Primary outcome
Physician comfort level and satisfaction when using the e2TM Collector compared to the standard spatula/cytobrush.
Time frame: Each physician will be surveyed after first and last use of the e2TM collector as well as three more times spaced at near regular intervals in between.
Results and safety
The study was stopped early (reason given: Terminated for lack of resources to complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
- 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 1575861Umland B, Waterman R, Wiese W, Duban S, Mennin S, Kaufman A. Learning from a rural physician program in China. Acad Med. 1992 May;67(5):307-9. doi: 10.1097/00001888-199205000-00004. 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.
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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 Pinkerton, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cell Collection, run by CytoCore, Inc. at 1 site 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Terminated for lack of resources to complete.). Results are not available in the source record.
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?
Physician comfort level and satisfaction when using the e2TM Collector compared to the standard spatula/cytobrush. (time frame: Each physician will be surveyed after first and last use of the e2TM collector as well as three more times spaced at near regular intervals in between.). 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 NCT00496314, 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 17 Jun 2008.