Cervical Intraepithelial NeoplasiaPhase 3NCT00156026
Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1
A Phase 3 study testing loop electrosurgical excision procedure (LEEP) in people with Cervical Intraepithelial Neoplasia, run by Ontario Clinical Oncology Group (OCOG) at 10 sites in 2 countries.
Trial summary
This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- loop electrosurgical excision procedure (LEEP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Nov 2000to Sep 2007
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible patients will:
- have documented CIN 1 by histologic assessment as the highest grade lesion present,
- have the lesion confined to the cervix and completely visualized,
- be 16 years or older.
Who cannot join
- any one of the following will be an excluding characteristic:
- index Pap smear showing CIN 2, CIN 3 or cancer;
- index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia, or malignancy requiring immediate investigation;
- patients with previously identified CIN 1 by biopsy who are already in a colposcopic surveillance program;
- unsatisfactory colposcopic exam defined as inability to see the extent of the lesion in the endocervical canal or absence of a lesion on the ectocervix but endocervical curettage shows CIN 1;
- pregnancy;
Show all 19Show fewer
- prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy;
- prior gynecologic cancer;
- prior pelvic radiation therapy;
- inability to attend outpatient follow-up visits because of geographic inaccessibility;
- other malignancies except non-melanoma skin cancer;
- immunosuppression due to diseases such as AIDS, organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus;
- cognitively impaired or otherwise unable to obtain written informed consent;
- extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia;
- colposcopically visible condyloma outside of the transformation zone;
- known allergy to local analgesics;
- clinically evident vaginitis must be treated and resolved prior to entry on the trial;
- inability to read and respond in English/French;
- failure to provide informed consent.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Canada8 sites
Brantford General Hospital
Brantford, Ontario, N3T 3J2
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Hamilton Health Sciences - Henderson Site
Hamilton, Ontario, L8P 3A9
London Health Sciences Centre
London, Ontario, N6A 4G5
Hôpital du Saint-Sacrement
Québec, Quebec, G1S 2L6
University of Saskatchewan
Saskatoon, Saskatchewan, S7K 3H3
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
B.C. Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Brazil2 sites
Universidade Estadual de Campinas
Campinas, CEP 13083-970
Instituto Fernandes Figueira - Oswaldo Cruz Foundation
Rio de Janeiro, CEP 22250-020
About this study
Official title: Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1
This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses.
Read the detailed description
In women who present with biopsy-proven CIN 1, to compare the management approach of regular colposcopic follow-up and only treating progressive disease using the LEEP, with an approach of immediate treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- loop electrosurgical excision procedure (LEEP)
- Keywords
- CIN 1, cervical intraepithelial neoplasia, cervix, cancer, loop electrosurgical excision procedure, LEEP, expectant management, human papilloma virus, HPV, colposcopy
- Medical subject headings
- Uterine Cervical Dysplasia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loop electrosurgical excision procedure (LEEP)Procedure or surgery
- loop electrosurgical excision procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Immediate Treatment - LEEP - Loop electrosurgical excision procedure Receives: Procedure: loop electrosurgical excision procedure (LEEP) |
| 2 | No intervention | Colposcopic Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression to more advanced disease
Measured: 18 months
Secondary outcomes (3)
persistent CIN 1 after 18 months
Measured: 18 months
bleeding.
Measured: 18 months
predict disease persistence or progression
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2000
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Laurie Elit, MD, Study chair, Juravinski Cancer CentreMark Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)Jim Julian, MMath, Principal investigator, McMaster University, Dept of Clinical Epidemiology & Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156026
- Sponsor's protocol ID
- OCOG-2000-CIN1
- Status last verified
- Jan 2009
- First submitted
- 8 Sep 2005
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1
- ClinicalTrials.gov ID
- NCT00156026
- Acronym / sponsor ID
- OCOG-2000-CIN1
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- CIN 1, cervical intraepithelial neoplasia, cervix, cancer, loop electrosurgical excision procedure, LEEP, expectant management, human papilloma virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2000
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Sep 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.
This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses.
Detailed description
In women who present with biopsy-proven CIN 1, to compare the management approach of regular colposcopic follow-up and only treating progressive disease using the LEEP, with an approach of immediate treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: loop electrosurgical excision procedure (LEEP)Immediate Treatment - LEEP - Loop electrosurgical excision procedure |
| 2 | No intervention | –Colposcopic Follow-up |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible patients will:
Key exclusion criteria (19 listed)
- any one of the following will be an excluding characteristic:
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 |
|---|---|---|
| loop electrosurgical excision procedure (LEEP)1. loop electrosurgical excision procedure | Procedure or surgery | 1 |
Primary outcome
progression to more advanced disease
Time frame: 18 months
3 secondary outcomes
persistent CIN 1 after 18 months
Time frame: 18 months
bleeding.
Time frame: 18 months
predict disease persistence or progression
Time frame: 18 months
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 29 Jan 2009.
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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.
Laurie Elit, MD study chair
Juravinski Cancer Centre
Mark Levine, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
Jim Julian, MMath principal investigator
McMaster University, Dept of Clinical Epidemiology & Biostatistics
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing loop electrosurgical excision procedure (LEEP) in people with Cervical Intraepithelial Neoplasia, run by Ontario Clinical Oncology Group (OCOG) at 10 sites in 2 countries.
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 4 inclusion and 19 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 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Brazil. 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.
What does the primary outcome measure?
progression to more advanced disease (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2009.