NCT06607809Completed
Inflammatory Markers (ICC, MCVL) and Nivolumab Response: Predicting Immunotherapy Success in Metastatic RCC
Association of Inflammatory Markers (ICC, MCVL) With Anti PD-1 Antibody Nivolumab Response: Evaluating Biomarkers for Predicting Immunotherapy Success in Patients With Metastatic Renal Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 8 Oct 2024
Brief summary (registry, in English)
This study is an observational study aimed at investigating the potential of new inflammatory markers to predict treatment response in patients with metastatic renal cell carcinoma (mRCC) undergoing anti-PD-1 antibody nivolumab therapy. Specifically, the study focuses on evaluating how well the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL) can predict the response to nivolumab treatment and the progression of the disease. The participant group consists of patients aged 18 and older who have been diagnosed with metastatic renal cell carcinoma. Inflammatory markers were monitored at regular intervals throughout the treatment period. The primary endpoints of the study are as follows: 1. Progression-Free Survival (PFS): To determine how long nivolumab treatment can halt disease progression. 2. Overall Survival (OS): To assess the overall survival of participants following treatment. 3. Disease Control Rate (DCR): To evaluate the disease control rates (stable disease, partial response, complete response) at 3, 6, and 12 months of Nivolumab treatment. This study aims to deeply analyze the impact of inflammatory markers such as ICC and MCVL on disease progression and treatment response, determining to what extent these markers serve as predictors of treatment success. Additionally, it explores how these markers can be utilized in personalized treatment strategies to improve therapeutic outcomes.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 99 (actual)
- First submitted
- 19 Sept 2024
- Start date
- 1 Feb 2022
- Primary completion date
- 1 Jan 2023
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT06607809
What you commit to
- Study type: Observational
- Participants enrolled: 99
- From 1 Feb 2022 to the primary completion date, 1 Jan 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other Active Cancers: Patients with concurrent active malignancies were excluded from the study.
- Prior Immunotherapy Treatment: Patients who had previously received any form of immunotherapy (anti-PD-1, anti-PD-L1, or similar immunological agents) were excluded.
- Immunodeficiency or Immunosuppressive Therapy: Patients with immunodeficiency or those receiving immunosuppressive therapy (e.g., corticosteroids) were excluded from the study.
Other illness
- Uncontrolled Systemic Diseases: Patients with severe, uncontrolled systemic diseases (e.g., significant cardiovascular, pulmonary, or liver diseases) were not included in the study.
- Active Infections: Patients with serious active infections, such as active tuberculosis, HIV infection, or chronic hepatitis B or C, were excluded.
Other
- Pregnancy and Breastfeeding: Pregnant or breastfeeding women were not eligible for inclusion in the study.
Who the study is looking for
- Age: Participants must be ≥18 and ≤87 years old. Diagnosis: Patients must have been diagnosed with metastatic renal cell carcinoma (mRCC).
- Treatment: Only patients receiving nivolumab treatment for metastatic renal cell carcinoma are included.
- Consent: Written informed consent was obtained from all participants
Age in the registry: 19 years to 87 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health Science University Kartal Dr. Lütfi Kirdar City Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.