Tumor Grade Determines PD-1/PDL-1 Expression

NCT ID: NCT04528940

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2021-09-30

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

Intervention Type: DIAGNOSTIC_TEST

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

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• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

RWJ Barnabas Health at Jersey City Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ariel polonsky

Role: PRINCIPAL_INVESTIGATOR

Jersey city medical centers

Locations

Jersey city medical center

Jersey City, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

ariel polonsky, MD

Role: CONTACT

arielpolonskymd@gmail.com

5512276993

Facility Contacts

ariel polonsky, MD

Role: primary

arielpolonskymd@gmail.com

551-227-6993

Other Identifiers

1289969

Identifier Type: -

Identifier Source: org_study_id