Investigating CRP Levels in Women with Advanced Gynecological Cancers Under Immunotherapy
ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
This study is trying to see if changes in a blood marker called CRP can help predict how well women with advanced gynecological cancers respond to immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT05914974 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with histologically confirmed metastatic gynecological malignancies who are eligible for ICI therapy.
Not a fit: Patients who have previously received ICI therapy or those with inadequate general health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for predicting treatment outcomes in women with advanced gynecological cancers undergoing immunotherapy.
How similar studies have performed: Previous studies in other cancer types have shown promising results regarding the predictive value of inflammatory markers like CRP in immunotherapy outcomes, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tübingen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.