Clinical trial NCT04528940: Tumor Grade Determines PD-1/PDL-1 Expression
Official title: Correlation Between Grade of Ovarian and Endometrial Carcinoma and the Expression of PD-1/PDL-1.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Ovarian Cancer
Lead sponsor: RWJ Barnabas Health at Jersey City Medical Center
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

-

Primary outcomes:
measure: Correlation between tumor grade and prevalence of PD-1/PDL-1 histologic staining
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jersey City
country: United States
facility: Jersey city medical center
state: New Jersey
Study officials:
affiliation: Jersey city medical centers
name: ariel polonsky
role: PRINCIPAL_INVESTIGATOR
References: