Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
NCT ID: NCT05914974
Last Updated: 2024-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2023-09-11
2035-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control Group
Chemotherapy without immunotherapy
No interventions assigned to this group
Experimental Group
Chemotherapy in combination with immunotherapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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University Hospital Ulm
OTHER
University Hospital Freiburg
OTHER
University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Dominik Dannehl, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Women's Health Tübingen
Locations
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Department of Women's Health
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZGynO_ICK-Gyn
Identifier Type: -
Identifier Source: org_study_id
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