Progesterone Induced Blocking Factor in Endometrial CancerNCT02852954
Progesterone Induced Blocking Factor Expression Levels in Endometrial Cancer Cells.
An observational study of Progesterone Induced Blocking Factor in Endometrial Cancer, run by Kayseri Education and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Progesterone Induced Blocking Factor in Endometrial Cancer
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- diagnosed endometrial cancer
- diagnosed endometrial hyperplasia
Who cannot join
- diagnosed cancer except endometrial cancer
About this study
Official title: Determining Levels of Expression of Progesterone-Induced Blocking Factor in Endometrial Cancer Cells.
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.
Read the detailed description
This retrospective controlled study will be conducted at both Obstetrics and Gynecology clinics and Pathology clinics of Kayseri Training and Research Hospital. This study will be conducted with the use of formalin fixed paraffin embedded tissue blocks immunohistochemically to determine the PIBF expression levels in the samples. 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 form the Pathology clinic of Kayseri Training and Research Hospital archives.
- Keywords
- Progesterone Induced Blocking Factor, Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemically Levels of PIBF in Endometrial Cancer Cells
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progesterone Induced Blocking Factor in Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erdem Sahin, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852954
- Sponsor's protocol ID
- 2016/405
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Levels of Expression of Progesterone-Induced Blocking Factor in Endometrial Cancer Cells.
- ClinicalTrials.gov ID
- NCT02852954
- Acronym / sponsor ID
- 2016/405
- Keywords
- Progesterone Induced Blocking Factor, Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This retrospective controlled study will be conducted at both Obstetrics and Gynecology clinics and Pathology clinics of Kayseri Training and Research Hospital. This study will be conducted with the use of formalin fixed paraffin embedded tissue blocks immunohistochemically to determine the PIBF expression levels in the samples. 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 form the Pathology clinic of Kayseri Training and Research Hospital archives.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- diagnosed endometrial cancer
- diagnosed endometrial hyperplasia
Key exclusion criteria (1 listed)
- diagnosed cancer except endometrial cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunohistochemically Levels of PIBF in Endometrial Cancer Cells
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Progesterone Induced Blocking Factor in Endometrial Cancer, run by Kayseri Education and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemically Levels of PIBF in Endometrial Cancer Cells (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.