Tumor Grade Determines PD-1/PDL-1 Expression

Ovarian Cancer Clinical Trial

Official title:

Correlation Between Grade of Ovarian and Endometrial Carcinoma and the Expression of PD-1/PDL-1.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528940
• Other study ID #: 1289969
• Status: Recruiting
• Start date: August 25, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2020
• Source: RWJ Barnabas Health at Jersey City Medical Center
• Contact: ariel polonsky, MD
• Phone: 5512276993
• Email: arielpolonskymd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Jersey city medical center	Jersey City	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
RWJ Barnabas Health at Jersey City Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between tumor grade and prevalence of PD-1/PDL-1 histologic staining	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