Investigating CRP Levels in Women with Advanced Gynecological Cancers Under Immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the prognostic significance of C-reactive protein (CRP) kinetics in women with advanced or metastatic gynecological malignancies receiving immune checkpoint inhibitor (ICI) therapy. By measuring CRP levels through routine blood samples, the study seeks to determine if changes in these inflammatory markers can predict treatment response, progression-free survival, and overall survival. The research is conducted across multiple centers and focuses on patients undergoing various lines of therapy, including those receiving palliative chemotherapy. The findings could enhance understanding of immunotherapy effectiveness in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* women ≥ 18 years of age
* histologically proven metastatic gynecological malignancies irrespective of therapy line
* patients with advanced or metastatic gynecological malignancies must fulfill treatment requirements for ICI therapy in the experimental group
* planned ICI therapy in combination with palliative chemotherapy in the experimental group
* patients with advanced or metastatic gynecological malignancies that undergo chemotherapy without ICIs in the first therapy line in the control group
* written informed consent into ICK-Gyn

Exclusion Criteria:

* missing indication for ICI therapy in the experimental group
* any ICI therapy before inclusion into the trial
* patients with advanced or metastatic endometrial or cervical cancer in the second or higher therapy line without indication to ICI therapy
* pregnant or lactating patients
* inadequate general condition (not fit for chemotherapy)

Where it's running

• Department of Women's Health
  Tübingen, Germany Recruiting

Study contacts

• Principal investigator: Dominik Dannehl, Dr. — Department of Women's Health Tübingen
• Study coordinator: Dominik Dannehl, Dr.
• Email: Dominik.Dannehl@med.uni-tuebingen.de
• Phone: 07071 29 82211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.