Prospective Cohort Study for Validation of Predictive Immune Biomarkers of Response to PAPR Inhibitors

NCT05640024 | Unknown

• 1 other identifier: 4-2022-1170
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Increasing number of ovarian cancer patients are receiving PARP inhibitor as maintenance therapy. Predictive factors to PARP inhibitor other than BRCA mutation or HRD status are unknown. Previous study, we analyzed the dynamic immunological changes in peripheral T cells during PARP inhibitor maintenance therapy and found predictive biomarkers. The purpose of this study is to prospectively validate the biomarkers for predicting response to PAPR inhibitors in ovarian cancer. We collect serial blood samples (before initiation of therapy and after 1, 3, and 6 months) in ovarian cancer patients who receive PARP inhibitor and analyze immunological characteristics of peripheral CD8 and regulatory T cells. Through assessment of the baseline properties and dynamic changes in T cells, we aim to validate the predictive biomarker and develope promising novel targets to enhancing survival outcomes of high-risk patients.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Validation of biomarkers for predicting response to PAPR inhibitor

  Investigators will utilize baseline peripherap blood mononuclear cells (PBMCs) to validate predictive biomarkers to PARP inhibitor. Response to PAPR inhibitor was defined by BRCA1/2 status and duration of PAPR inhibitor treatment.

  The primary endpont will be accessed 12 months after last patient registration.

Secondary Outcomes (2)

• Identify dynamic immunological changes during PAPR inhibitor therapy

  Immunological changes (Time Frame: 6 months

• Identify promising novel targets to enhance survivla outcomes of high-risk pateints in PAPR inhibitor therapy.

  Identify promising novel targets (Time Frame: 12 months)

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ovarian cancer patients who receive PARP inhibitor

You may qualify if:

• \. Pathological diagnosis of epithelial ovarian cancer, 2. Presence of germline or somatic BRCA mutational status result, 3. Advanced or recurrent ovarian cancer patients who responded to their most recent platinum-based chemotherapy and plan to start PARPi (olaparib or niraparib) maintenance therapy.

You may not qualify if:

• \. Patients who refuse to participate, 2. Patients having difficulty understanding the protocol due to language barrier

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Circulating tumor DNA based on whole blood. The investigator will peripheral blood from ovarian cancer patients receiving PARP inhibitor for every three months until progression.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jung-Yun Lee

  Yonsei University College of Medicine Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Yun Lee

CONTACT

82-2-2228-2237; jungyunlee@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 7, 2022
• Study Start: November 6, 2022
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)