- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528940
Tumor Grade Determines PD-1/PDL-1 Expression
August 23, 2020 updated by: RWJ Barnabas Health at Jersey City Medical Center
Correlation Between Grade of Ovarian and Endometrial Carcinoma and the Expression of PD-1/PDL-1.
Endometrial carcinoma is the most common gynecologic cancer in the western world.
Two types are usually described.
Type I is the endometrioid and is usually estrogen dependent.
Type II is usually more aggressive than type I and is estrogen independent.
Type II endometrial cancer is usually characterized as high grade while type I as low intermediate and high grade.
Ovarian carcinoma as opposed to endometrial carcinoma is not characterized by types but by different histological backgrounds.
It is also divided into high and low grade tumors.
Ovarian carcinoma is considered to be the most aggressive of all gynecological malignancies resulting in most yearly deaths.
Our immune system usually responds to foreign intruders entering our body or formed inside and attacks it in order to destroy it.
Cancer cells are considered to be foreign to the body hence the immune system is expected to destroy it .
The immune mediated cells which are supposed to attack the cancer are called tumor infiltrating lymphocytes or "TILS".
Many different cancers possess the ability to evade TILS in order to survive and grow.
Many studies have demonstrated that the presence of large number of TILS improved cancer prognosis.
One of these evasive methods is the PD-1/PDL-1 expression.
The question whether more aggressive tumors possess better capabilities to evade an immune response via the PD-1/PDL-1 mechanism is currently unknown.
All tumor types possess antigens on their cell surface which triggers an immune response to some extent.
Even though, the tumor needs different methods in order to be able to avoid the immune system attack.
TILS express the PD-1 receptor on their cell surface and when it binds to PDL-1 or PDL-2, the cells which express the ligand deactivate TILS hence deem the lymphocyte incapable of inducing programmed cell death.
PDL-1 which is expressed on tumor cells to evade an immune response can be targeted by immunotherapy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ariel polonsky, MD
- Phone Number: 5512276993
- Email: arielpolonskymd@gmail.com
Study Locations
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New Jersey
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Jersey City, New Jersey, United States, 07302
- Recruiting
- Jersey City Medical Center
-
Contact:
- ariel polonsky, MD
- Phone Number: 551-227-6993
- Email: arielpolonskymd@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The sample consists of 100 patients from all ages and races.
These patients have to be diagnosed with either ovarian or endometrial carcinoma of all stages and grades.
In addition, the cancerous specimen needs to stain positive for PD-1/PDL-1.
Description
Inclusion Criteria:
All ages Endometrial carcinoma Ovarian carcinoma All grades All stages All races Female patients PD-1/PDL-1 staining positive -
Exclusion Criteria:
Any cancer which is not endometrial or ovarian Cancer which do not stain positive for PD-1/PDL-1
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between tumor grade and prevalence of PD-1/PDL-1 histologic staining
Time Frame: Through study completion, an average of 12 months
|
The purpose of the study is to show that the more the tumor is aggressive the higher is the prevalence of PD-1/PDL-1 staining.
so every endometrial and ovarian tumors diagnosed will be stained and linear regression curves constructed to look for correlation
|
Through study completion, an average of 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: ariel polonsky, Jersey city medical centers
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 25, 2020
Primary Completion (Anticipated)
September 30, 2021
Study Completion (Anticipated)
September 30, 2021
Study Registration Dates
First Submitted
August 23, 2020
First Submitted That Met QC Criteria
August 23, 2020
First Posted (Actual)
August 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 27, 2020
Last Update Submitted That Met QC Criteria
August 23, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1289969
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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