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Brief Title: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Official Title: ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Study ID: NCT05914974
Brief Summary: ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).
Detailed Description: Immunotherapy, which involves activating the body's immune system for cancer treatment, has already been widely incorporated into the standard care of patients with advanced and metastatic gynecological cancers. This study aims to investigate how inflammatory markers such as C-reactive protein (CRP) change during and after immunotherapy. Study findings from other tumor types (kidney, lung, bladder) suggest that immunotherapy is particularly effective when a mild inflammatory response is triggered in the body. The investigators want to examine this using CRP measurement. CRP measurement can easily be integrated into clinical routine as it only requires a blood sample. The goal of this prospective study is to determine whether changes in CRP levels in the blood can predict the disease progression or response to immunotherapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Department of Women's Health, Tuebingen, , Germany
Name: Dominik Dannehl, Dr.
Affiliation: Department of Women's Health Tübingen
Role: PRINCIPAL_INVESTIGATOR