Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

NCT05914974 | Recruiting

• 1 other identifier: ZGynO_ICK-Gyn
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Gynecological Malignancies; Vulvar Cancer; Endometrial Cancer; Ovarian Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS)

  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.

  duration of therapy and follow-up data (10 years)

Secondary Outcomes (1)

• Prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under ICI therapy on the objective response rate (ORR) and overall survival (OS).

  duration of therapy and follow-up data (10 years)

Study Arms (2)

Control Group

Chemotherapy without immunotherapy

Experimental Group

Chemotherapy in combination with immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• missing indication for ICI therapy in the experimental group
• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• University Hospital Ulm: collaborator
• University Hospital Freiburg: collaborator

Study Sites (1)

Department of Women's Health

Tübingen, 72076, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample to assess laboratory parameters: Leukocytes, neutrophil granulocytes, lymphocytes, hemoglobin, hematocrit, thrombocytes, kreatinin, glomerular filtration rate (GFR), serum glutamic oxaloacetic transaminase (GOT), serum glutamic pyruvic transaminase (GPT), bilirubin, lactate dehydrogenase (LDH), thyroid stimulating hormone (TSH), fT3 (free tri-iodothyronine), fT4 (free thyroxine), amylase, CRP, biomarkers related to immune response

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vulvar Diseases

Study Officials

• Dominik Dannehl, Dr.

  Department of Women's Health Tübingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Dannehl, Dr.

CONTACT

07071 29 82211; Dominik.Dannehl@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2035
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)