Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607809
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Inflammatory Markers ICC MCVL and Nivolumab Response Predicting Immunotherapy Success in Metastatic RCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMNR
Brief Summary:
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 VolumeLymphocyte 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
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
Detailed Description:
This observational study investigates 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 The study specifically aims to evaluate how well the Cumulative Inflammatory Index ICC and Mean Corpuscular VolumeLymphocyte Ratio MCVL can predict the response to nivolumab treatment and the progression of the disease
Detailed Characteristics of the Participants
Age Range The participants cover a wide age range from young adults to elderly individuals
Gender and General Health Status The gender of the participants is not specified but all participants are adults diagnosed with metastatic renal cell carcinoma Most have previously undergone treatment for renal cancer and their disease has metastasized
Histological Subtypes The majority of participants have clear cell renal cell carcinoma clear cell RCC Other histological subtypes including papillary chromophobe and sarcomatoid types are also represented
Metastasis Status A significant proportion of the participants show metastasis to multiple organs These metastases are most commonly found in the lungs bones brain and liver
Blood Parameters Throughout the treatment the blood values of the participants were regularly monitored These parameters include white blood cells WBC red blood cells RBC hemoglobin HGB hematocrit HCT mean corpuscular volume MCV platelets PLT neutrophils and lymphocytes
Inflammatory Markers The study tracks inflammatory markers such as the Cumulative Inflammatory Index ICC and Mean Corpuscular VolumeLymphocyte Ratio MCVL in participants These markers are believed to play an important role in the progression of the disease and the response to treatment
Primary Endpoints of the Study
Progression-Free Survival PFS The ability of nivolumab treatment to halt the progression of the disease over time is assessed
Overall Survival OS The overall survival of participants following treatment is analyzed
Disease Control Rate DCR The disease control rates stable disease partial response complete response at various time points during nivolumab treatment are evaluated
Study Objective
The primary aim of this study is to analyze the impact of inflammatory markers such as ICC and MCVL on disease progression and treatment response Additionally it seeks to explore how these markers can predict treatment success and be used in personalized treatment strategies
Detailed Characteristics of the Participants
Age Range The participants cover a wide age range from young adults to elderly individuals
Gender and General Health Status The gender of the participants is not specified but all participants are adults diagnosed with metastatic renal cell carcinoma Most have previously undergone treatment for renal cancer and their disease has metastasized
Histological Subtypes The majority of participants have clear cell renal cell carcinoma clear cell RCC Other histological subtypes including papillary chromophobe and sarcomatoid types are also represented
Metastasis Status A significant proportion of the participants show metastasis to multiple organs These metastases are most commonly found in the lungs bones brain and liver
Blood Parameters Throughout the treatment the blood values of the participants were regularly monitored These parameters include white blood cells WBC red blood cells RBC hemoglobin HGB hematocrit HCT mean corpuscular volume MCV platelets PLT neutrophils and lymphocytes
Inflammatory Markers The study tracks inflammatory markers such as the Cumulative Inflammatory Index ICC and Mean Corpuscular VolumeLymphocyte Ratio MCVL in participants These markers are believed to play an important role in the progression of the disease and the response to treatment
Primary Endpoints of the Study
Progression-Free Survival PFS The ability of nivolumab treatment to halt the progression of the disease over time is assessed
Overall Survival OS The overall survival of participants following treatment is analyzed
Disease Control Rate DCR The disease control rates stable disease partial response complete response at various time points during nivolumab treatment are evaluated
Study Objective
The primary aim of this study is to analyze the impact of inflammatory markers such as ICC and MCVL on disease progression and treatment response Additionally it seeks to explore how these markers can predict treatment success and be used in personalized treatment strategies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None