Cervical Intraepithelial NeoplasiaPhase 4CIN2NCT00733109
Management of Cervical Intraepithelial Neoplasia Grade 2
A Phase 4 study testing Excision of the lesion and Follow-up for spontaneous regression of the lesion in people with Cervical Intraepithelial Neoplasia, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12… Read more about this study
- Who is it for?
- Ages 18 to 61 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Excision of the lesion and Follow-up for spontaneous regression of the lesion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2003to Jul 2007
- Phase
- Phase 4
- 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 to 61 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Histological CIN2 diagnosis
Who cannot join
- Previous CIN treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Leonor Mendes de Barros Maternity Hospital
São Paulo, São Paulo, 03015000
About this study
The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.
Read the detailed description
Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy.
The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Excision of the lesion, Follow-up for spontaneous regression of the lesion
- Keywords
- CIN2, management
- 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.
Excision of the lesionProcedure or surgery
Also called LEETZ
Surgery with Large Loop Excision of Transformation Zone (LLETZ)
Follow-up for spontaneous regression of the lesionOther
Also called conservative managment
Follow-up at last 12 months
| Study group | Role | What they receive |
|---|---|---|
| excision of the lesion | Active comparator | Not described Receives: Procedure: Excision of the lesion |
| espontaneous regression | No intervention | Not described Receives: Other: Follow-up for spontaneous regression of the lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startMar 2003
- Primary completionJul 2006
- Study completionJul 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Sylvia F Brenna, MD, PhD, Principal investigator, Universidade Cidade de Sao PauloAna C Guedes, MD, PhD, Principal investigator, Universidade Cidade de Sao PauloKari J Sirjanen, MD, PhD, Study chair, University of TurkuLuis C Zeferino, MD, PhD, Study director, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733109
- Sponsor's protocol ID
- CIN 2
- Acronym
- CIN2
- Status last verified
- Aug 2008
- First submitted
- 7 Aug 2008
- Last updated
- 11 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Cervical Intraepithelial Neoplasia Grade 2
- ClinicalTrials.gov ID
- NCT00733109
- Acronym / sponsor ID
- CIN2 / CIN 2
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- CIN2, management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Aug 2008 (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.
The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.
Detailed description
Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy.
The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| excision of the lesion | Active comparator | Procedure: Excision of the lesion |
| espontaneous regression | No intervention | Other: Follow-up for spontaneous regression of the lesion |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Histological CIN2 diagnosis
Key exclusion criteria (1 listed)
- Previous CIN treatment
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 |
|---|---|---|
| Excision of the lesionAlso: LEETZSurgery with Large Loop Excision of Transformation Zone (LLETZ) | Procedure or surgery | excision of the lesion |
| Follow-up for spontaneous regression of the lesionAlso: conservative managmentFollow-up at last 12 months | Other | espontaneous regression |
Primary outcome
43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9%
Time frame: 12 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 11 Jan 2010.
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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.
Sylvia F Brenna, MD, PhD principal investigator
Universidade Cidade de Sao Paulo
Ana C Guedes, MD, PhD principal investigator
Universidade Cidade de Sao Paulo
Kari J Sirjanen, MD, PhD study chair
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Excision of the lesion and Follow-up for spontaneous regression of the lesion in people with Cervical Intraepithelial Neoplasia, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 11 Jan 2010. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9% (time frame: 12 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 11 Jan 2010.