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Proposal 1258

Title of the Proposed Research

Advance lung cancer inflammation index (ALI) in metastatic non-squamous lung cancer: A validation study

Lead Researcher

Syed Hasan Raza Jafri

Affiliation

University of Texas
Houston, Texas, USA

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

11 Nov 2015

Lay Summary

Lay Summary Lung cancer is the leading cause of cancer death worldwide. A quarter of all cancer-related deaths in the US are attributed to lung cancer alone. More women die every year from lung cancer than from breast cancer. Most patients with lung cancer at the time of diagnosis already have metastatic disease. On average these patients are expected to live for one year although some studies show that one third of these patients never receive chemotherapy and die much earlier.

Using a retrospective patient data base researchers at the University of Texas- Houston and Louisiana state university-Shreveport have developed a prognostic index called advanced lung cancer inflammation index (ALI) . ALI is calculated using patient’s height and weight and very basic laboratory parameters. Two other groups have also shown usefulness of ALI in predicting outcomes in patients with small cell lung cancer and esophageal cancer. The current study proposes to validate ALI as a prognostic marker in patients using clinical trial data available through clinicalstudydatarequest.com. For the current proposal we have chosen ABIGAIL clinical trial which is a prospective randomized phase II study in patients with metastatic non-squamous non-small cell lung cancer. Data obtained in a prospective study design like (ABIGAIL;B021015) is of much better quality and less likely to have errors than a retrospective data set as was used previously to develop ALI. The aim of the study will be to confirm whether ALI can predict which patients with advanced non-squamous metastatic lung cancer are expected to live longer than others. If confirmed ALI will serve as an important tool in identifying high risk advanced lung cancer patients not only in routine clinical care but also in designing future lung cancer clinical trials. Once completed, we expect to share our research findings through presentation in scientific meetings publication in research journals.

Study Data Provided

Study ROCHE-BO21015: A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.