High-Grade Squamous Intraepithelial LesionsNCT04115787
Conservative Management in Patients Diagnosed With Grade 2 or Grade 3 CIN
An observational study of High-Grade Squamous Intraepithelial Lesions and Neoplasm Regression, Spontaneous, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Consecutive inclusion and collection of information for all women attending the Cervical Disease Unit with an histological diagnosis of grade 2 or grade 3 CIN during the last 5 years, from January 2012 to December 2016, which meet the inclusion criteria, have voluntarily manifested pregnancy intendedness and had a… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- High-Grade Squamous Intraepithelial Lesions, Neoplasm Regression, Spontaneous, Disease Progression
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 14 Oct 2019to 28 Dec 2019
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women attending the Cervical Disease Unit with an histological diagnosis of grade 2 or grade 3 CIN during the last 5 years, from January 2012 to December 2016, which meet the inclusion criteria, have voluntarily manifested pregnancy intendedness and had a minimum follow-up time of 2 years and a maximum of 7.
Who may be able to join
- Reproductive age and willing to get pregnant in the future
- Acceptance of conservative management
- Commitment to study visits.
- Colposcopy with zone of transformation (ZT) type 1 or 2 (Unio esco-columnar totally visible) with image compatible with H-SIL and visible in its entirety.
Who cannot join
- Pregnant women
- Immunosuppression for human immunodeficiency virus (HIV) or iatrogenic type
- suspicion or diagnosis of Glandular Cell Atipia (ACG), Adenocarcinoma in situ (AIS) or cervical cancer (CC)
- Provided that inclusion criteria are not met
Trial locations and contacts
1 site in 1 country.
About this study
Consecutive inclusion and collection of information for all women attending the Cervical Disease Unit with an histological diagnosis of grade 2 or grade 3 CIN during the last 5 years, from January 2012 to December 2016, which meet the inclusion criteria, have voluntarily manifested pregnancy intendedness and had a minimum follow-up time of 2 years and a maximum of 7.
The aim is to evaluate whether the HSIL resolution rates (CIN 2 or CIN 3) are sufficient to support conservative management.
Read the detailed description
Follow-up is performed every 4 months with colposcopy, cytology and biopsies. Colposcopy and cytology are performed for all control subjects. The need for biopsy is established according to the colposcopy exam findings to confirm H-SIL or cervical cancer. Follow-up is spaced every 6 months if the cytology and biopsy results indicate L-SIL / ASCUS in agreement with the colposcopic image. HPV tests are performed every 8-12 months. This strategy is maintained until the resolution of the H-SIL.
The conservative management stops if the H-SIL lesion persists after 24 months of follow-up, if the inclusion criteria are no longer met or if the exclusion ones are met.
Inclusion and exclusion criteria are reviewed at each visit and the conservative management ceases in case the patient decides to undergo conization.
- Conditions
- High-Grade Squamous Intraepithelial Lesions, Neoplasm Regression, Spontaneous, Disease Progression, Papillomavirus Infections
- Medical subject headings
- Squamous Intraepithelial Lesions, Neoplasm Regression, Spontaneous, Disease Progression, Papillomavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
H-SIL Resolution
In cases where H-SIL (cytologic, histological and colposcopic) is no longer detected during follow-up.
Include the strict resolution, indulgent resolution and regression
Measured: 24 months
H-SIL Regression
H-SIL is not detected, but with a low grade cytological, histologic or colposcopic lesion
Measured: 24 months
Secondary outcomes (4)
Factors probably related to the resolution
Demographics (age and origin), viral type, cytology, biopsy and colposcopy will be recorded at the beginning and end of the follow-up, as well as time until resolution, regression or progression and conization result.
Measured: 24 months
Strict resolution
Negative HPV determination or different from the initial
Measured: 24 months
Lenient resolution
Colposcopy lesion disappearance, negative results on cytology and biopsies with persistence of the same viral type of high initial grade.
Measured: 24 months
Conization surgery
Patients undergoing surgery
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start14 Oct 2019 (estimated)
- Primary completion28 Nov 2019 (estimated)
- Study completion28 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade Squamous Intraepithelial LesionsStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115787
- Sponsor's protocol ID
- IIBSP-CIN-2019-50
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Management in Patients Diagnosed With Grade 2 or Grade 3 CIN
- ClinicalTrials.gov ID
- NCT04115787
- Acronym / sponsor ID
- IIBSP-CIN-2019-50
- Conditions
- High-Grade Squamous Intraepithelial Lesions, Neoplasm Regression, Spontaneous, Disease Progression, Papillomavirus Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 14 Oct 2019 (estimated)
- Primary completion
- 28 Nov 2019 (estimated)
- Study completion
- 28 Dec 2019 (estimated)
- First posted
- 4 Oct 2019 (actual)
- 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.
Consecutive inclusion and collection of information for all women attending the Cervical Disease Unit with an histological diagnosis of grade 2 or grade 3 CIN during the last 5 years, from January 2012 to December 2016, which meet the inclusion criteria, have voluntarily manifested pregnancy intendedness and had a minimum follow-up time of 2 years and a maximum of 7.
The aim is to evaluate whether the HSIL resolution rates (CIN 2 or CIN 3) are sufficient to support conservative management.
Detailed description
Follow-up is performed every 4 months with colposcopy, cytology and biopsies. Colposcopy and cytology are performed for all control subjects. The need for biopsy is established according to the colposcopy exam findings to confirm H-SIL or cervical cancer. Follow-up is spaced every 6 months if the cytology and biopsy results indicate L-SIL / ASCUS in agreement with the colposcopic image. HPV tests are performed every 8-12 months. This strategy is maintained until the resolution of the H-SIL.
The conservative management stops if the H-SIL lesion persists after 24 months of follow-up, if the inclusion criteria are no longer met or if the exclusion ones are met.
Inclusion and exclusion criteria are reviewed at each visit and the conservative management ceases in case the patient decides to undergo conization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women attending the Cervical Disease Unit with an histological diagnosis of grade 2 or grade 3 CIN during the last 5 years, from January 2012 to December 2016, which meet the inclusion criteria, have voluntarily manifested pregnancy intendedness and had a minimum follow-up time of 2 years and a maximum of 7.
Key inclusion criteria (4 listed)
- Reproductive age and willing to get pregnant in the future
- Acceptance of conservative management
- Commitment to study visits.
- Colposcopy with zone of transformation (ZT) type 1 or 2 (Unio esco-columnar totally visible) with image compatible with H-SIL and visible in its entirety.
Key exclusion criteria (4 listed)
- Pregnant women
- Immunosuppression for human immunodeficiency virus (HIV) or iatrogenic type
- suspicion or diagnosis of Glandular Cell Atipia (ACG), Adenocarcinoma in situ (AIS) or cervical cancer (CC)
- Provided that inclusion criteria are not met
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
H-SIL Resolution
Time frame: 24 months
In cases where H-SIL (cytologic, histological and colposcopic) is no longer detected during follow-up. Include the strict resolution, indulgent resolution and regression
H-SIL Regression
Time frame: 24 months
H-SIL is not detected, but with a low grade cytological, histologic or colposcopic lesion
4 secondary outcomes
Factors probably related to the resolution
Time frame: 24 months
Strict resolution
Time frame: 24 months
Lenient resolution
Time frame: 24 months
Conization surgery
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 High-Grade Squamous Intraepithelial Lesions and Neoplasm Regression, Spontaneous, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 4 Oct 2019. 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 Spain. 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?
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?
H-SIL Resolution (time frame: 24 months). The study lists 2 primary outcomes in all. 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 Oct 2019.