P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer

December 26, 2010 updated by: Rambam Health Care Campus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women diagnosed with endometrial cancer, having undergone surgery and having received chemotherapy in our institution.

Description

Inclusion Criteria:

  • diagnosis of endometrial cancer
  • histology block exists in hospital's library

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Serous papillary endometrial ca patients
30 patients diagnosed with SP endometrial ca
Other: no intervention
Endometrioid endometrial ca
32 patients diagnosed with Endometrioid endometrial ca
Other: no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: last followup (2-10 years)
last followup (2-10 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: Current follow up (2-10 years)
Current follow up (2-10 years)
correlation of P16 stain with histological diagnosis
Time Frame: at last follow up (2-10 years)
at last follow up (2-10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 15, 2010

First Submitted That Met QC Criteria

December 26, 2010

First Posted (Estimate)

December 28, 2010

Study Record Updates

Last Update Posted (Estimate)

December 28, 2010

Last Update Submitted That Met QC Criteria

December 26, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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