Meta-analysis of the Prognostic Value of Lymphocyte to Monocyte Ratio (LMR) in Non-metastatic Renal Cell Carcinoma. (LMR)

December 31, 2019 updated by: Dario Garcia-Rojo, Corporacion Parc Tauli

Prognostic Value of Pretreatment Lymphocyte-to-monocyte Ratio in Patients With in Non-metastatic Renal Cell Carcinoma: a Systematic Review and Meta-analysis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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, mean/median 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> 0.05, the heterogeneity will be not substantial. Thus, a fixed-effect model will be used to calculate forest plots. If p < 0.05, 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 Tweedie's "trim-and-fill" test will be used to correct possible publication bias.

Statistical significance was defined as p less than 0.05.

Statistics will done using R 3.5.0 (R Core Team, 2018) and the meta (v4.1-5; Schwarzer, Guido, 2019) package.

Study Type

Observational

Enrollment (Anticipated)

4666

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Outside U.S./Canada
      • Sabadell, Outside U.S./Canada, Spain, 08208
        • Recruiting
        • Corporacion Parc Tauli
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with non-metastatic renal cell carcinoma who underwent radical or partial nephrectomy

Description

Inclusion Criteria:

  • 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 or language will be applied.

  • Cohort or observational studies in patients with non-metastatic renal cell carcinoma who underwent radical or partial nephrectomy, 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.

    • -There were no restrictions about gender and ethnicity.

Exclusion Criteria:

  • Reviews, case reports, conference abstracts, letters, animal or cell studies.
  • Patients were diagnosed non-metastatic renal cell carcinoma, but without standard treatments (Ablative therapy).
  • Preoperative inflammatory markers were not measured.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-metastatic renal cell carcinoma
Pretreatment lymphocyte to monocyte ratio in non-metastatic patients with renal cell
Other: prognosis
cancer and overall survival cancer specific survival cancer and recurrence-free survival cancer and disease-free survival lymphocyte to monocyte ratio in non-metastatic renal cancer and progression-free survival

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Lymphocyte to Monocyte Ratio ( LMR) is a prognostic factor in non-metastatic renal cell carcinoma
Time Frame: Preoperative Lymphocyte to Monocyte Ratio ( LMR) will be determined one month before surgical treatment. Follow-up: through study completion, an average of 5 years.
Preoperative Lymphocyte to Monocyte Ratio ( LMR) is a prognostic factor patients who underwent nephrectomy for non-metastatic renal cell carcinoma
Preoperative Lymphocyte to Monocyte Ratio ( LMR) will be determined one month before surgical treatment. Follow-up: through study completion, an average of 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Garcia-Rojo, Corporacion Parc Tauli.Sabadell. Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 31, 2019

Primary Completion (ANTICIPATED)

January 2, 2020

Study Completion (ANTICIPATED)

January 31, 2020

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

December 27, 2019

First Posted (ACTUAL)

December 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPT-URO-2019
  • 2019/679 (REGISTRY: Corporacion Parc Tauli)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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