Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dominik Dannehl, Dr.
- Phone Number: 07071 29 82211
- Email: Dominik.Dannehl@med.uni-tuebingen.de
Study Locations
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Tübingen, Germany, 72076
- Recruiting
- Department of Women's Health
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Contact:
- Tobias Engler, Dr.
- Phone Number: 07071 29 82211
- Email: Tobias.Engler@med.uni-tuebingen.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
120 patients will be included in the study after written informed consent. Of 60 patients in the control group, which will undergo chemotherapy of physician's choice, 25 patients will be diagnosed with advanced or metastatic cervical cancer, 25 patients will be diagnosed with advanced or metastatic endometrial cancer and 10 patients will be diagnosed with advanced or metastatic ovarian or vulvar cancer.
Of 60 patients in the experimental group, which will undergo palliative chemotherapy in combination with ICIs, 25 patients will be diagnosed with advanced or metastatic cervical cancer, 25 patients will be diagnosed with advanced or metastatic endometrial cancer and 10 patients will be diagnosed with advanced or metastatic ovarian or vulvar cancer.
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control Group
Chemotherapy without immunotherapy
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Experimental Group
Chemotherapy in combination with immunotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS)
Time Frame: duration of therapy and follow-up data (10 years)
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Evaluation of CRP kinetics to predict progression-free survival in advanced or metastatic gynecological malignancies treated with ICIs in combination with chemotherapy.
The CRP value is determined from blood samples.
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duration of therapy and follow-up data (10 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under ICI therapy on the objective response rate (ORR) and overall survival (OS).
Time Frame: duration of therapy and follow-up data (10 years)
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duration of therapy and follow-up data (10 years)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dominik Dannehl, Dr., Department of Women's Health Tübingen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Uterine Cervical Diseases
- Uterine Neoplasms
- Vulvar Diseases
- Ovarian Neoplasms
- Uterine Cervical Neoplasms
- Endometrial Neoplasms
- Vulvar Neoplasms
Other Study ID Numbers
- ZGynO_ICK-Gyn
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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