NCT01267357

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2010

Completed
Last Updated

December 28, 2010

Status Verified

November 1, 2010

Enrollment Period

4 months

First QC Date

December 15, 2010

Last Update Submit

December 26, 2010

Conditions

Serous Papillary Endometrial Cancer

Keywords

Serous Papillary Endometrial CancerEndometrioid endometrial cancerbiomarkersP16P53Prognosis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    last followup (2-10 years)

Secondary Outcomes (2)

  • progression free survival

    Current follow up (2-10 years)

  • correlation of P16 stain with histological diagnosis

    at last follow up (2-10 years)

Study Arms (2)

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

Interventions

no interventionOTHER
Endometrioid endometrial caSerous papillary endometrial ca patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

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.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 28, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2010

Last Updated

December 28, 2010

Record last verified: 2010-11

Locations

IL(1)