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

NCT02522585 | Completed DMC

• 1 other identifier: CIN-II p16 NK
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cervical Cancer

Keywords

expectant management; p16; immunohistochemistry; regression; progression; cervical intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (1)

Conservative management

Patients diagnosed of CIN-II by directed biopsy

Other: Conservative management

Interventions

Conservative management OTHER

Control of CIN-II with cytology and colposcopy to try to avoid unnecessary surgery

Conservative management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• not coming to follow up appointments

Sponsors & Collaborators

• Parc de Salut Mar: lead

Related Publications (6)

• 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.

  PMID: 21193261 BACKGROUND

• Tsoumpou 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 BACKGROUND

• del 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 BACKGROUND

• Galgano 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 BACKGROUND

• Guedes 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 BACKGROUND

• McAllum 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Citologies and biopsies of the cervix. Blood cells.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Disease Progression; Uterine Cervical Dysplasia

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gemma Mancebo, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

• Ramon Carreras, PhD

  Parc de Salut Mar

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 13, 2015
• Study Start: December 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04