Tumor Grade Determines PD-1/PDL-1 Expression

NCT04528940 | Unknown DMC

• 1 other identifier: 1289969
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 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.

Conditions

Endometrial Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

PD-1/PDL-1 staining DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Gender Eligibility Details: Female genital tract specific carcinomas
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All ages Endometrial carcinoma Ovarian carcinoma All grades All stages All races Female patients PD-1/PDL-1 staining positive -

You may not qualify if:

• Any cancer which is not endometrial or ovarian Cancer which do not stain positive for PD-1/PDL-1

Sponsors & Collaborators

• RWJ Barnabas Health at Jersey City Medical Center: lead

Study Sites (1)

Jersey city medical center

Jersey City, New Jersey, 07302, United States

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• ariel polonsky

  Jersey city medical centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ariel polonsky, MD

CONTACT

5512276993; arielpolonskymd@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 27, 2020
• Study Start: August 25, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

US (1)