Cervical Intraepithelial NeoplasiaNCT02540421
Recurrence in High-grade Lesions After Conization
An observational study of Cervical Intraepithelial Neoplasia, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
Objectives: To identify factors associated with disease recurrence in patients with high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the transformation zone (LLETZ). Study Design: A case-control study that included 103 patients. 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
- How many people
- 103 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2001to Dec 2007
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III).
Who may be able to join
- 1. history of surgery for conization
Who cannot join
- under 18 years of age,
- immunosuppressed,
- Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia
- Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Presence of Positive Resection Margins, Hypooestrogenism and Specimen Volume May Influence Risk of Disease Recurrence in Patients With High-grade Cervical Intra-epithelial Neoplasia Undergoing Large Loop Excision of the Transformation Zone
Objectives: To identify factors associated with disease recurrence in patients with high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the transformation zone (LLETZ).
Study Design: A case-control study that included 103 patients. Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III). Follow-up exams were conducted every six months with Pap smear collection and colposcopic examination with biopsy, when necessary, for a minimum period of twelve months. Cure was defined as a normal follow-up examination within 24 months. During follow-up, relapse occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at which time a new cervical conization by LLETZ was performed.
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- cervical intraepithelial neoplasia, human papillomavirus, conization
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Case | Recurrent lesions | |
| Control | Absence of lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rates after conization
Number of patients who are regarded as recurrence based on the following criteria:
- relapse occurred when cytology and/or biopsy showed that CIN had returned after 12 months
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 posted4 Sep 2015 (estimated)
- Study startJan 2001
- Primary completionJan 2007
- Study completionDec 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emerson Oliveira, Faculdade de Medicina do ABC
- Investigators
- EMERSON OLIVEIRA, PhD, Principal investigator, FACULTY OF MEDICINE OF ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540421
- Sponsor's protocol ID
- CIN1701
- Status last verified
- Sep 2015
- First submitted
- 15 Oct 2014
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Positive Resection Margins, Hypooestrogenism and Specimen Volume May Influence Risk of Disease Recurrence in Patients With High-grade Cervical Intra-epithelial Neoplasia Undergoing Large Loop Excision of the Transformation Zone
- ClinicalTrials.gov ID
- NCT02540421
- Acronym / sponsor ID
- CIN1701
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- cervical intraepithelial neoplasia, human papillomavirus, conization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Sep 2015 (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.
Objectives: To identify factors associated with disease recurrence in patients with high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the transformation zone (LLETZ).
Study Design: A case-control study that included 103 patients. Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III). Follow-up exams were conducted every six months with Pap smear collection and colposcopic examination with biopsy, when necessary, for a minimum period of twelve months. Cure was defined as a normal follow-up examination within 24 months. During follow-up, relapse occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at which time a new cervical conization by LLETZ was performed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Recurrent lesions |
| Control | – | –Absence of lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III).
Key inclusion criteria (1 listed)
- 1. history of surgery for conization
Key exclusion criteria (4 listed)
- under 18 years of age,
- immunosuppressed,
- Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia
- Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence rates after conization
Time frame: 12 months
Number of patients who are regarded as recurrence based on the following criteria: - relapse occurred when cytology and/or biopsy showed that CIN had returned after 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 4 Sep 2015.
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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.
EMERSON OLIVEIRA, PhD principal investigator
FACULTY OF MEDICINE OF ABC
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 Intraepithelial Neoplasia, run by Faculdade de Medicina do ABC 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 4 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 4 Sep 2015. 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.
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?
Recurrence rates after conization (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 4 Sep 2015.