Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04213664
Status:
UNKNOWN
Last Update Posted:
2020-01-02
First Post:
2019-12-25
Brief Title:
Meta-analysis of the Prognostic Value of Lymphocyte to Monocyte Ratio LMR in Non-metastatic Renal Cell Carcinoma
Sponsor:
Corporacion Parc Tauli
Organization:
Corporacion Parc Tauli
Study Overview
Official Title:
Prognostic Value of Pretreatment Lymphocyte-to-monocyte Ratio in Patients With in Non-metastatic Renal Cell Carcinoma a Systematic Review and Meta-analysis
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LMR
Brief Summary:
PubMed ScienceDirect Cochrane Database of Systematic Reviews will be used to search for articles published from January 1965 to July 2019 using the key words renal cancer lymphocyte to monocyte ratio and prognosis No restrictions to date language or article type will be applied Cohort or observational studies in patients with non-metastatic renal cell carcinoma histopathologically confirmed with hazard ratios HR and corresponding 95 confidence intervals CI that assessed association between LMR and overall survival OS cancer-specific survival CSS recurrence-free survival RFS and disease-free survival DFS will be analyzed
Detailed Description:
A systematic review of the literature will be carried out using Patient Intervention Comparison and Outcome method PICO with the aim of answering the following clinical question Is pretreatment under lymphocyte to monocyte ratio LMR a prognostic factor in non-metastatic renal cell carcinoma
All analyzes will be based on previously published studies For this reason patient consent and ethical approval will not be required
An exhaustive search will be conducted in PubMed Science Direct and Cochrane Database of Systematic Reviews for eligible studies that explored the prognostic role of LMR in patients with localized renal tumors who underwent to partial or radical nephrectomy from January 1965 to July 2019 The terms search will include monocyte lymphocyte ratio renal cancer prognosis
Cohort studies or observational studies will be included patients with localized renal tumors who underwent partial or radical nephrectomy with histopathologically confirmed neoplasms who had access to the full text and without language limitation
Inclusion
Any observational study cross-sectional case-control longitudinal with cross-sectional data will be included
Patients with localized renal tumors who underwent partial or radical nephrectomy with histopathologically confirmed neoplasms who had access to the full text and without language limitation will be included
Exclusion Reviews case reports conference abstracts letters animal or cell studies
Relevant articles will be identified in duplicate by two independent reviewers by first screening the titles and abstracts followed by the full text against inclusion and exclusion criteria Any disagreement will be resolved by consensus with a third reviewer experienced in the renal cancer management
The studies reflected the hazard ratio HR and corresponding 95 confidence intervals CI in which the overall survival OS specific cancer specific survival CSS recurrence-free survival RFS disease-free survival DFS and progression-free survival PFP
Information will be extracted for the first author publication year geographic location study design patient information sample size meanmedian age sex distribution performance status LMR endpoint OS CSS RFS DFS PFS therapy follow up duration multivariate factors hazard ratio HR and corresponding 95 confidence intervals CIs or exact P values When univariate HR and multivariate HR were both reported only the multivariate HR will be used
OS is defined as the interval from the date of surgery in the primary tumor until death CSS is defined as the interval from the date of surgery in the primary tumor to death for urological tumors RFS is defined as the interval from the date of surgery in the primary tumor to local regional or distant recurrence or death from any cause DFS is defined as the interval from the date of surgery in the primary tumor to local regional or distant recurrence PFS is defined as the interval from the date of surgery in the primary tumor to the progression of the disease including local recurrence or distant metastasis or death
The Newcastle-Ottawa Scale NOS will be used to assess the quality of studies A maximum of 9 points can be given for each study in the categories of selection of patients comparability of the study groups and assessment of outcomes We will define high-quality studies with scores 7
If the necessary data are available subgroup analyses will be performed to explore the potential sources of heterogeneity according to country analysis type tumor type sample size and cut-off value
Statistical study
Data will be combined using random effect models The Cochrane χ² Cochrane Q statistic and the I² test will be used to analyze heterogeneity
Before calculating the combined results for all trials statistical heterogeneity will be evaluated by using the I² statistic and p-value which assessed the appropriateness of pooling the individual study results The I² value provided an estimate of the amount of variance across studies because of heterogeneity rather than chance I² values of 25 50 and 75 corresponded to low moderate and high levels of heterogeneity respectively If p 005 the heterogeneity will be not substantial Thus a fixed-effect model will be used to calculate forest plots If p 005 however the heterogeneity will be considered substantial Then a random effects models were used
The publication bias will be graphically explored through funnel plot and Duval and Tweedies trim-and-fill test will be used to correct possible publication bias
Statistical significance was defined as p less than 005
Statistics will done using R 350 R Core Team 2018 and the meta v41-5 Schwarzer Guido 2019 package
All analyzes will be based on previously published studies For this reason patient consent and ethical approval will not be required
An exhaustive search will be conducted in PubMed Science Direct and Cochrane Database of Systematic Reviews for eligible studies that explored the prognostic role of LMR in patients with localized renal tumors who underwent to partial or radical nephrectomy from January 1965 to July 2019 The terms search will include monocyte lymphocyte ratio renal cancer prognosis
Cohort studies or observational studies will be included patients with localized renal tumors who underwent partial or radical nephrectomy with histopathologically confirmed neoplasms who had access to the full text and without language limitation
Inclusion
Any observational study cross-sectional case-control longitudinal with cross-sectional data will be included
Patients with localized renal tumors who underwent partial or radical nephrectomy with histopathologically confirmed neoplasms who had access to the full text and without language limitation will be included
Exclusion Reviews case reports conference abstracts letters animal or cell studies
Relevant articles will be identified in duplicate by two independent reviewers by first screening the titles and abstracts followed by the full text against inclusion and exclusion criteria Any disagreement will be resolved by consensus with a third reviewer experienced in the renal cancer management
The studies reflected the hazard ratio HR and corresponding 95 confidence intervals CI in which the overall survival OS specific cancer specific survival CSS recurrence-free survival RFS disease-free survival DFS and progression-free survival PFP
Information will be extracted for the first author publication year geographic location study design patient information sample size meanmedian age sex distribution performance status LMR endpoint OS CSS RFS DFS PFS therapy follow up duration multivariate factors hazard ratio HR and corresponding 95 confidence intervals CIs or exact P values When univariate HR and multivariate HR were both reported only the multivariate HR will be used
OS is defined as the interval from the date of surgery in the primary tumor until death CSS is defined as the interval from the date of surgery in the primary tumor to death for urological tumors RFS is defined as the interval from the date of surgery in the primary tumor to local regional or distant recurrence or death from any cause DFS is defined as the interval from the date of surgery in the primary tumor to local regional or distant recurrence PFS is defined as the interval from the date of surgery in the primary tumor to the progression of the disease including local recurrence or distant metastasis or death
The Newcastle-Ottawa Scale NOS will be used to assess the quality of studies A maximum of 9 points can be given for each study in the categories of selection of patients comparability of the study groups and assessment of outcomes We will define high-quality studies with scores 7
If the necessary data are available subgroup analyses will be performed to explore the potential sources of heterogeneity according to country analysis type tumor type sample size and cut-off value
Statistical study
Data will be combined using random effect models The Cochrane χ² Cochrane Q statistic and the I² test will be used to analyze heterogeneity
Before calculating the combined results for all trials statistical heterogeneity will be evaluated by using the I² statistic and p-value which assessed the appropriateness of pooling the individual study results The I² value provided an estimate of the amount of variance across studies because of heterogeneity rather than chance I² values of 25 50 and 75 corresponded to low moderate and high levels of heterogeneity respectively If p 005 the heterogeneity will be not substantial Thus a fixed-effect model will be used to calculate forest plots If p 005 however the heterogeneity will be considered substantial Then a random effects models were used
The publication bias will be graphically explored through funnel plot and Duval and Tweedies trim-and-fill test will be used to correct possible publication bias
Statistical significance was defined as p less than 005
Statistics will done using R 350 R Core Team 2018 and the meta v41-5 Schwarzer Guido 2019 package
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019679 | REGISTRY | Corporacion Parc Tauli | None |