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P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01267357
First Posted: December 28, 2010
Last Update Posted: December 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  Purpose

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.


Condition Intervention
Serous Papillary Endometrial Cancer Other: no intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Expression of the P16 Protein in Serous Papillary Endometrial Cancer, and Its Clinical and Prognostic Significance

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Overall survival [ Time Frame: last followup (2-10 years) ]

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

Biospecimen Retention:   Samples With DNA

Existing paraffin pathology blocks in hospital's library were used. Remainder of material was returned to the library.

No identifying features were retained or attached to specimens.


Enrollment: 62
Study Start Date: July 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women diagnosed with endometrial cancer, having undergone surgery and having received chemotherapy in our institution.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267357


Locations
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

Responsible Party: Dr. Itamar Netzer, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01267357     History of Changes
Other Study ID Numbers: 230CTIL
First Submitted: December 15, 2010
First Posted: December 28, 2010
Last Update Posted: December 28, 2010
Last Verified: November 2010

Keywords provided by Rambam Health Care Campus:
Serous Papillary Endometrial Cancer
Endometrioid endometrial cancer
biomarkers
P16
P53
Prognosis

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female