Recruiting

Observational Study

Sponsor:

RWJ Barnabas Health at Jersey City Medical Center

Code:

NCT04528940

Conditions

Endometrial Cancer

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

PD-1/PDL-1 staining

Study Details

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.

Conditions

Endometrial Cancer

Ovarian Cancer

Study ID

NCT04528940

Start date

Aug 25, 2020

Status verified date

Aug, 2020

Completion date

Sep 30, 2021

Anticipated

Primary completion date

Sep 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

PD-1/PDL-1 staining

Every endometrial or ovarian carcinoma will be stained for PD-1/PDL-1. The stage and grade of the tumor will be determined and correlation between tumor grade and stage and PD-1/PDL-1 staining will be made.

Primary outcome measure

  • Correlation between tumor grade and prevalence of PD-1/PDL-1 histologic staining [ Time Frame: Through study completion, an average of 12 months ]

Central Contacts and Locations

Central contacts

Locations

Jersey city medical center

Recruiting

Jersey City, New Jersey, United States, 07302

Contacts

More Information

Sponsor

RWJ Barnabas Health at Jersey City Medical Center

Last update posted

Aug 27, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RWJ Barnabas Health at Jersey City Medical Center on 2020-08-27.