NCT05914974 Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
| NCT ID | NCT05914974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Tuebingen |
| Condition | Gynecological Malignancies |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-09-11 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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)
Contact & Investigator
Dominik Dannehl, Dr.
PRINCIPAL INVESTIGATOR
Department of Women's Health Tübingen
Frequently Asked Questions
Who can join the NCT05914974 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gynecological Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05914974 currently recruiting?
Yes, NCT05914974 is actively recruiting participants. Contact the research team at Dominik.Dannehl@med.uni-tuebingen.de for enrollment information.
Where is the NCT05914974 trial being conducted?
This trial is being conducted at Tübingen, Germany.
Who is sponsoring the NCT05914974 clinical trial?
NCT05914974 is sponsored by University Hospital Tuebingen. The principal investigator is Dominik Dannehl, Dr. at Department of Women's Health Tübingen. The trial plans to enroll 120 participants.