Cervical Intraepithelial NeoplasiaPhase 3NCT00237562
Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit
A Phase 3 study testing Large loop electrosurgical excision in people with Cervical Intraepithelial Neoplasia, run by University of California, Irvine at 1 site in United States.
Trial summary
1. Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women; 2. Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time; 3. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Large loop electrosurgical excision
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to not given
- Phase
- Phase 3
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years
- No history of invasive cervical cancer
- Not pregnant
Who cannot join
- Absence of a cervix
- Abnormal vaginal bleeding
- Cervical cancer screening within the previous 12 months
- A known bleeding disorder
- Reluctance to be randomized
- Unwillingness to follow the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Orange, California, 92868
About this study
Official title: Single Visit Cervical Cancer Prevention Program
- Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women;
- Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time;
- Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP);
- Determine satisfaction and compare it between women assigned to the SVP and the UCP;
- Determine the cost-effectiveness and compare it between the SVP and UCP
Read the detailed description
Women were recruited from underserved communities to participate in this single visit cervix cancer project. Large loop electrosurgical excision procedure (LEEP) was performed on SVP subjects with either a diagnosis of HGSIL/AGUS or suspicion of carcinoma. All other subjects with abnormal Papanicolaou smears were referred to our abnormal cytology clinics or received care in the community.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Large loop electrosurgical excision
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large loop electrosurgical excisionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Alberto Manetta, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237562
- Sponsor's protocol ID
- R01CA076501
- Status last verified
- Oct 2005
- First submitted
- 10 Oct 2005
- Last updated
- 5 May 2006
- Results posted
- No
Publications
Brewster WR, Hubbell FA, Largent J, Ziogas A, Lin F, Howe S, Ganiats TG, Anton-Culver H, Manetta A. Feasibility of management of high-grade cervical lesions in a single visit: a randomized controlled trial. JAMA. 2005 Nov 2;294(17):2182-7. doi: 10.1001/jama.294.17.2182.
PubMed 16264159
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Visit Cervical Cancer Prevention Program
- ClinicalTrials.gov ID
- NCT00237562
- Acronym / sponsor ID
- R01CA076501
- Conditions
- Cervical Intraepithelial Neoplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1999
- First posted
- 12 Oct 2005 (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.
- Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women;
- Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time;
- Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP);
- Determine satisfaction and compare it between women assigned to the SVP and the UCP;
- Determine the cost-effectiveness and compare it between the SVP and UCP
Detailed description
Women were recruited from underserved communities to participate in this single visit cervix cancer project. Large loop electrosurgical excision procedure (LEEP) was performed on SVP subjects with either a diagnosis of HGSIL/AGUS or suspicion of carcinoma. All other subjects with abnormal Papanicolaou smears were referred to our abnormal cytology clinics or received care in the community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years
- No history of invasive cervical cancer
- Not pregnant
Key exclusion criteria (6 listed)
- Absence of a cervix
- Abnormal vaginal bleeding
- Cervical cancer screening within the previous 12 months
- A known bleeding disorder
- Reluctance to be randomized
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 |
|---|---|---|
| Large loop electrosurgical excision | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2006.
- Results publication: PubMed 16264159Brewster WR, Hubbell FA, Largent J, Ziogas A, Lin F, Howe S, Ganiats TG, Anton-Culver H, Manetta A. Feasibility of management of high-grade cervical lesions in a single visit: a randomized controlled trial. JAMA. 2005 Nov 2;294(17):2182-7. doi: 10.1001/jama.294.17.2182.
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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.
Alberto Manetta, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Large loop electrosurgical excision in people with Cervical Intraepithelial Neoplasia, run by University of California, Irvine 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 6 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 5 May 2006. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237562, which also lists 1 linked publication.
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 5 May 2006.