P16 Staining as Prognostic Biomarker in Serous Papillary... | NCT01267357

Studies
P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer

NCT01267357

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Dec 28, 2010Estimated

Enrollment

62Actual

Phase

Not provided

Conditions

Serous Papillary Endometrial Cancer

Interventions

no intervention

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Not provided

First Submitted Date

Dec 15, 2010

First Submission Date that Met QC Criteria

Dec 26, 2010

First Posted Date

Dec 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2010

Last Update Posted Date

Dec 28, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other		Endometrioid endometrial ca Serous papillary endometrial ca patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Description

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.