Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)NCT00343213
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.
A study testing colposcopy in people with Cervical Intraepithelial Neoplasia Grade 1 (CIN 1), run by University Hospital, Strasbourg, France at 3 sites in France.
Trial summary
P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse, whereas in CIN 1 different staining… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
- What is being tested?
- colposcopy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2006to not given
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Responsible women > 18 years with histologically proven CIN 1
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Service de Gynécologie-Obstétrique - Centre Hospitalier Général
Haguenau
Dominique Collin, MD, 3.33.88.06.30.67, dominique.collin@ch-haguenau.fr
- Recruiting
Service de gynécologie-obtétrique - Centre Hospitalier Général
Saverne
Jean-Luc Harter, MD, 3.33.88.71.65.17, jeanluc.harter@ch-saverne.fr
- Recruiting
Département de Gynécologie-Obstétrique - Hôpital de Hautepierre
Strasbourg, 67098
Jean-Jacques Baldauf, MD, 3.33.88.12.74.59, jean-jacques.baldauf@chru-strasbourg.fr
About this study
Official title: Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix. Immunohistochemical Study on Biopsies (Retrospective and Prospective Analysis) and on Liquid Based (SurePath) Cervical Cytology (Prospective Analysis). Correlation With HPV Typing and Clinical Outcome.
P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse, whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is able to predict the outcome of the lesion. The retrospective part of the study includes cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years. p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2 pathologists without knowledge of clinical data.
- Being tested
- colposcopy
- Keywords
- Prognostic value of p16INK4a, CIN 1, LSIL, HPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colposcopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
p16INK4a staining pattern and HPV status of the initial biopsy
Secondary outcomes (1)
p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Jacques Baldauf, MD, Study director, Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343213
- Sponsor's protocol ID
- 3454
- Status last verified
- Aug 2011
- First submitted
- 21 Jun 2006
- Last updated
- 30 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix. Immunohistochemical Study on Biopsies (Retrospective and Prospective Analysis) and on Liquid Based (SurePath) Cervical Cytology (Prospective Analysis). Correlation With HPV Typing and Clinical Outcome.
- ClinicalTrials.gov ID
- NCT00343213
- Acronym / sponsor ID
- 3454
- Keywords
- Prognostic value of p16INK4a, CIN 1, LSIL, HPV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2006
- First posted
- 22 Jun 2006 (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.
P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse, whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is able to predict the outcome of the lesion. The retrospective part of the study includes cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years. p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2 pathologists without knowledge of clinical data.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| colposcopy | Procedure or surgery | – |
Primary outcome
p16INK4a staining pattern and HPV status of the initial biopsy
1 secondary outcome
p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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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.
Jean-Jacques Baldauf, MD study director
Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colposcopy in people with Cervical Intraepithelial Neoplasia Grade 1 (CIN 1), run by University Hospital, Strasbourg, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Contact Jean-Jacques Baldauf, MD (3.33.88.12.74.59, jean-jacques.baldauf@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
p16INK4a staining pattern and HPV status of the initial biopsy. 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 30 Aug 2011.