Cervical CancerNCT02522585
p16 and Ki-67 Stainings and Natural Killer (NK) Cells in CIN-II Management
An observational study of Cervical Cancer, run by Parc de Salut Mar.
Trial summary
The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and ki-67 immunohistochemical staining and to the expression of NK cell receptors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Conservative management
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult females with CIN-II lesion on cervical biopsy that agree to a conservative management during a period not more than 24 months, referred to the low genital tract diseases clinic of Hospital del Mar.
Who may be able to join
- preferred expectant management than immediate treatment
- exocervical histological diagnosis of CIN-II
- lesion completely visualized by colposcopy
- entire squamocolumnar junction of the cervix was visible
- showing no evidence of any immunodeficiency disease
- no history of previous cervical treatment
- could be followed-up every four months during one year
- signed consent form
Who cannot join
- not coming to follow up appointments
About this study
Official title: Predictive Value of p16 and Ki-67 Immunohistochemical Staining and NK Cells in Expectant Management of Cervical Intraepithelial Neoplasia Grade 2
The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and ki-67 immunohistochemical staining and to the expression of NK cell receptors.
Read the detailed description
Cervical cancer and its precursor lesions, cervical intraepithelial neoplasia (CIN), represents a significant public health problem,induced by persistent infection of human papillomavirus (HPV). It is known that a significant percentage of CIN regresses spontaneously and only a minority of these lesions progress to cervical cancer. CIN-II is an intermediate state that can regress to CIN-I or less, or progress to CIN-III spontaneously. The rate of spontaneous regression and progression in follow-up studies are around 40-60% and 10-20%, respectively. Overestimating CIN-II lesions may cause overtreatment by excisional treatment and increase the risk of subsequent obstetric complications.
Patients newly diagnosed with CIN-II colposcopy-directed biopsy who agreed to follow up at four months intervals for at least 12 months with cervical cytology and colposcopy, were prospectively recruited. p16, ki-67 and NK receptors expression were analyzed in all CIN-II biopsies. Total regression, partial regression, persistence and progression rates of CIN-II were defined as a final outcome.
- Conditions
- Cervical Cancer
- Being tested
- Conservative management
- Keywords
- expectant management, p16, immunohistochemistry, regression, progression, cervical intraepithelial neoplasia
- Medical subject headings
- Uterine Cervical Neoplasms, Disease Progression, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative managementOther
Control of CIN-II with cytology and colposcopy to try to avoid unnecessary surgery
| Study group | Role | What they receive |
|---|---|---|
| Conservative management | Patients diagnosed of CIN-II by directed biopsy Receives: Other: Conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of cervix pathology using cervical smear test (CIN grade)
Cervical cytology test and colposcopy every 4 months starting with diagnose CIN-II or CIN-III means presence of lesion, CIN-I is regression of the lesion, and Negative is abscence of lesion.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startDec 2011
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Genoves, Parc de Salut Mar
- Investigators
- Gemma Mancebo, PhD, Principal investigator, Parc de Salut MarRamon Carreras, PhD, Study chair, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522585
- Sponsor's protocol ID
- CIN-II p16 NK
- Status last verified
- Apr 2016
- First submitted
- 7 Aug 2015
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Discacciati MG, de Souza CA, d'Otavianno MG, Angelo-Andrade LA, Westin MC, Rabelo-Santos SH, Zeferino LC. Outcome of expectant management of cervical intraepithelial neoplasia grade 2 in women followed for 12 months. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):204-8. doi: 10.1016/j.ejogrb.2010.12.002. Epub 2010 Dec 28.
PubMed 21193261Tsoumpou I, Arbyn M, Kyrgiou M, Wentzensen N, Koliopoulos G, Martin-Hirsch P, Malamou-Mitsi V, Paraskevaidis E. p16(INK4a) immunostaining in cytological and histological specimens from the uterine cervix: a systematic review and meta-analysis. Cancer Treat Rev. 2009 May;35(3):210-20. doi: 10.1016/j.ctrv.2008.10.005. Epub 2009 Mar 3.
PubMed 19261387del Pino M, Garcia S, Fuste V, Alonso I, Fuste P, Torne A, Ordi J. Value of p16(INK4a) as a marker of progression/regression in cervical intraepithelial neoplasia grade 1. Am J Obstet Gynecol. 2009 Nov;201(5):488.e1-7. doi: 10.1016/j.ajog.2009.05.046. Epub 2009 Aug 15.
PubMed 19683687Galgano MT, Castle PE, Atkins KA, Brix WK, Nassau SR, Stoler MH. Using biomarkers as objective standards in the diagnosis of cervical biopsies. Am J Surg Pathol. 2010 Aug;34(8):1077-87. doi: 10.1097/PAS.0b013e3181e8b2c4.
PubMed 20661011Guedes AC, Brenna SM, Coelho SA, Martinez EZ, Syrjanen KJ, Zeferino LC. p16(INK4a) Expression does not predict the outcome of cervical intraepithelial neoplasia grade 2. Int J Gynecol Cancer. 2007 Sep-Oct;17(5):1099-103. doi: 10.1111/j.1525-1438.2007.00899.x. Epub 2007 Mar 15.
PubMed 17367324McAllum B, Sykes PH, Sadler L, Macnab H, Simcock BJ, Mekhail AK. Is the treatment of CIN 2 always necessary in women under 25 years old? Am J Obstet Gynecol. 2011 Nov;205(5):478.e1-7. doi: 10.1016/j.ajog.2011.06.069. Epub 2011 Jun 25.
PubMed 21872201
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of p16 and Ki-67 Immunohistochemical Staining and NK Cells in Expectant Management of Cervical Intraepithelial Neoplasia Grade 2
- ClinicalTrials.gov ID
- NCT02522585
- Acronym / sponsor ID
- CIN-II p16 NK
- Conditions
- Cervical Cancer
- Keywords
- expectant management, p16, immunohistochemistry, regression, progression, cervical intraepithelial neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Aug 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.
The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and ki-67 immunohistochemical staining and to the expression of NK cell receptors.
Detailed description
Cervical cancer and its precursor lesions, cervical intraepithelial neoplasia (CIN), represents a significant public health problem,induced by persistent infection of human papillomavirus (HPV). It is known that a significant percentage of CIN regresses spontaneously and only a minority of these lesions progress to cervical cancer. CIN-II is an intermediate state that can regress to CIN-I or less, or progress to CIN-III spontaneously. The rate of spontaneous regression and progression in follow-up studies are around 40-60% and 10-20%, respectively. Overestimating CIN-II lesions may cause overtreatment by excisional treatment and increase the risk of subsequent obstetric complications.
Patients newly diagnosed with CIN-II colposcopy-directed biopsy who agreed to follow up at four months intervals for at least 12 months with cervical cytology and colposcopy, were prospectively recruited. p16, ki-67 and NK receptors expression were analyzed in all CIN-II biopsies. Total regression, partial regression, persistence and progression rates of CIN-II were defined as a final outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conservative management | – | Other: Conservative managementPatients diagnosed of CIN-II by directed biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult females with CIN-II lesion on cervical biopsy that agree to a conservative management during a period not more than 24 months, referred to the low genital tract diseases clinic of Hospital del Mar.
Key inclusion criteria (8 listed)
- preferred expectant management than immediate treatment
- exocervical histological diagnosis of CIN-II
- lesion completely visualized by colposcopy
- entire squamocolumnar junction of the cervix was visible
- showing no evidence of any immunodeficiency disease
Key exclusion criteria (1 listed)
- not coming to follow up appointments
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 |
|---|---|---|
| Conservative managementControl of CIN-II with cytology and colposcopy to try to avoid unnecessary surgery | Other | Conservative management |
Primary outcome
Status of cervix pathology using cervical smear test (CIN grade)
Time frame: 2 years
Cervical cytology test and colposcopy every 4 months starting with diagnose CIN-II or CIN-III means presence of lesion, CIN-I is regression of the lesion, and Negative is abscence of lesion.
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 20 Apr 2016.
- Background: PubMed 21193261Discacciati MG, de Souza CA, d'Otavianno MG, Angelo-Andrade LA, Westin MC, Rabelo-Santos SH, Zeferino LC. Outcome of expectant management of cervical intraepithelial neoplasia grade 2 in women followed for 12 months. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):204-8. doi: 10.1016/j.ejogrb.2010.12.002. Epub 2010 Dec 28.
- Background: PubMed 19261387Tsoumpou I, Arbyn M, Kyrgiou M, Wentzensen N, Koliopoulos G, Martin-Hirsch P, Malamou-Mitsi V, Paraskevaidis E. p16(INK4a) immunostaining in cytological and histological specimens from the uterine cervix: a systematic review and meta-analysis. Cancer Treat Rev. 2009 May;35(3):210-20. doi: 10.1016/j.ctrv.2008.10.005. Epub 2009 Mar 3.
- Background: PubMed 19683687del Pino M, Garcia S, Fuste V, Alonso I, Fuste P, Torne A, Ordi J. Value of p16(INK4a) as a marker of progression/regression in cervical intraepithelial neoplasia grade 1. Am J Obstet Gynecol. 2009 Nov;201(5):488.e1-7. doi: 10.1016/j.ajog.2009.05.046. Epub 2009 Aug 15.
- Background: PubMed 20661011Galgano MT, Castle PE, Atkins KA, Brix WK, Nassau SR, Stoler MH. Using biomarkers as objective standards in the diagnosis of cervical biopsies. Am J Surg Pathol. 2010 Aug;34(8):1077-87. doi: 10.1097/PAS.0b013e3181e8b2c4.
- Background: PubMed 17367324Guedes AC, Brenna SM, Coelho SA, Martinez EZ, Syrjanen KJ, Zeferino LC. p16(INK4a) Expression does not predict the outcome of cervical intraepithelial neoplasia grade 2. Int J Gynecol Cancer. 2007 Sep-Oct;17(5):1099-103. doi: 10.1111/j.1525-1438.2007.00899.x. Epub 2007 Mar 15.
- Background: PubMed 21872201McAllum B, Sykes PH, Sadler L, Macnab H, Simcock BJ, Mekhail AK. Is the treatment of CIN 2 always necessary in women under 25 years old? Am J Obstet Gynecol. 2011 Nov;205(5):478.e1-7. doi: 10.1016/j.ajog.2011.06.069. Epub 2011 Jun 25.
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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.
Gemma Mancebo, PhD principal investigator
Parc de Salut Mar
Ramon Carreras, PhD study chair
Parc de Salut Mar
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Parc de Salut Mar.
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 8 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 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Status of cervix pathology using cervical smear test (CIN grade) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02522585, which also lists 6 linked publications.
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 20 Apr 2016.