P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer

Serous Papillary Endometrial Cancer Clinical Trial

Official title:

Expression of the P16 Protein in Serous Papillary Endometrial Cancer, and Its Clinical and Prognostic Significance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267357
• Other study ID #: 230CTIL
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: December 26, 2010
• Start date: July 2010

Study information

• Verified date: November 2010
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma. Evidence from previous trials indicates that it may be used as a diagnostic biomarker distinguishing this disease from endometrioid endometrial cancer. Additional evidence points to its prognostic value.

The current study will evaluate p16 both as a diagnostic tool for serous papillary endometrial cancer and as a prognostic biomarker.

following anonymization, histology blocks will be microtomed and stained for P16 and P53 proteins.

Blocks from endometrioid endometrial cancer will be used as a control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of endometrial cancer

• histology block exists in hospital's library

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Serous Papillary Endometrial Cancer

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		last followup (2-10 years)	No
Secondary	progression free survival		Current follow up (2-10 years)	No
Secondary	correlation of P16 stain with histological diagnosis		at last follow up (2-10 years)	No