Clinical trial · Observational

p16 and Ki-67 Stainings and Natural Killer (NK) Cells in CIN-II Management

Predictive Value of p16 and Ki-67 Immunohistochemical Staining and NK Cells in Expectant Management of Cervical Intraepithelial Neoplasia Grade 2

NCT02522585CI-TRIAL-00021860completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cervical Cancer	Malignant Cervical Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Conservative management	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Conservative management
description
Patients diagnosed of CIN-II by directed biopsy
interventionNames
1. Other: Conservative management

Primary outcomes (1)

measure
Status of cervix pathology using cervical smear test (CIN grade)
timeFrame
2 years
description
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.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* 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

Exclusion Criteria:

* not coming to follow up appointments

References

Publications (6)

BACKGROUNDDiscacciati 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. PMID 21193261
BACKGROUNDTsoumpou 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. PMID 19261387
BACKGROUNDdel 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. PMID 19683687
BACKGROUNDGalgano 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. PMID 20661011
BACKGROUNDGuedes 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. PMID 17367324
BACKGROUNDMcAllum 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. PMID 21872201