Actively Recruiting
ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Led by University Hospital Tuebingen · Updated on 2026-02-10
120
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
U
University Hospital Ulm
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how changes in C-reactive protein (CRP), an inflammatory marker, relate to outcomes in women with advanced or metastatic gynecological cancers receiving immunotherapy. This observational study focuses on the value of CRP levels during immune checkpoint inhibitor (ICI) treatment, aiming to understand how CRP changes predict response rates, progression-free survival, and overall survival. Immunotherapy is already part of standard care for these cancers, and this study builds on findings from other cancers where mild inflammation indicates better treatment effect. Participants will be observed under two groups: those receiving chemotherapy alone and those receiving chemotherapy combined with immunotherapy. The study tracks CRP levels through blood samples during and after the therapy. It includes women with metastatic gynecological cancers who are starting either ICI therapy with chemotherapy or chemotherapy without ICI, depending on treatment plans. The study is prospective and multicenter, with follow-up planned over 10 years. During the study, participants will provide regular blood samples for CRP measurement alongside their usual care. Researchers will monitor how CRP changes relate to disease progression and treatment response. They will evaluate outcomes such as progression-free survival, objective response rate, and overall survival over a long-term follow-up. Consent and eligibility screening occur before enrollment, and participants' health and treatment status will be recorded throughout the study period.
CONDITIONS
Brief Title
Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years of age or older
- Histologically confirmed metastatic gynecological malignancies regardless of therapy line
- Eligible for immune checkpoint inhibitor (ICI) therapy if in the experimental group
- Planned ICI therapy combined with palliative chemotherapy for the experimental group
- Planned chemotherapy without ICI in the first therapy line for the control group
- Provided written informed consent to participate in ICK-Gyn
You will not qualify if you...
- No indication for ICI therapy in the experimental group
- Prior ICI therapy before trial inclusion
- Advanced or metastatic endometrial or cervical cancer in second or higher therapy line without ICI indication
- Pregnant or lactating women
- Poor general condition unsuitable for chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 years
Participants have their C-reactive protein (CRP) levels measured through blood samples before, during, and after chemotherapy and immunotherapy to observe inflammatory marker changes.
Regular blood sample collections integrated with clinical routine
Trial Site Locations
Total: 1 location
1
Department of Women's Health
Tübingen, Germany, 72076
Actively Recruiting
Research Team
D
Dominik Dannehl, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here