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Trial Title:
Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
NCT ID:
NCT05914974
Condition:
Gynecological Malignancies
Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Vulvar Cancer
Conditions: Official terms:
Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial
(IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or
metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on
the objective response rate (ORR), progression-free survival (PFS) and overall survival
(OS).
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Women's Health
Address:
City:
Tuebingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Tobias Engler, Dr.
Phone:
07071 29 82211
Email:
Tobias.Engler@med.uni-tuebingen.de
Start date:
September 11, 2023
Completion date:
April 2035
Lead sponsor:
Agency:
University Hospital Tuebingen
Agency class:
Other
Collaborator:
Agency:
University Hospital Ulm
Agency class:
Other
Collaborator:
Agency:
University Hospital Freiburg
Agency class:
Other
Source:
University Hospital Tuebingen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05914974
