NCT02852954

Brief Summary

Immune system suppression effect of Progesterone Induced Blocking Factor(PIBF), it could be questionable whether tumor cells express PIBF for escape of immune system. There are some studies in the literature that evaluate PIBF expression of different malign cells (e.g. glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary brain tumor, lung cancer and chorionic carcinoma). According to previous studies PIBF has been used as an anti-tumor immune suppressor by tumor cells. There is no data about the PIBF expression of endometrial tumor cells. Therefore, the investigators aim to determine the PIBF expression levels in the endometrial cancer cells.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

July 29, 2016

Last Update Submit

August 15, 2017

Conditions

Progesterone Induced Blocking Factor in Endometrial Cancer

Keywords

Progesterone Induced Blocking FactorEndometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • Immunohistochemically Levels of PIBF in Endometrial Cancer Cells

    3 months

Study Arms (3)

study group1

20 paraffin embedded blocks which was diagnosed endometrial cancer

control group

20 paraffin embedded blocks of healthy women

study group2

20 paraffin embedded blocks which was diagnosed endometrial hyperplasia

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

There are three groups in this study; endometrial cancer,endometrial hyperplasia and normal endometrium and each of the groups contained 20 paraffin embedded blocks provided from the Pathology clinic of Kayseri Training and Research Hospital archives.

You may qualify if:

  • diagnosed endometrial cancer
  • diagnosed endometrial hyperplasia

You may not qualify if:

  • diagnosed cancer except endometrial cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 2, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

August 18, 2017

Record last verified: 2016-08