Effect of Symptom Management on Inflammation and Survival in Metastatic Lung Cancer

NCT02271581 | Completed

• 1 other identifier: INSYNC
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

There is a growing body of evidence that implicates inflammation as a mechanism of disease progression and reduced survival in patients with advanced cancer. Elevated c-reactive protein levels have been shown to be associated with reduced performance status, specific cancer related symptoms and reduced overall survival. C-reactive protein levels are a surrogate for IL-6 expression. IL-6 is part of an inflammatory signature predicting cancer recurrence. VeriStrat® is a multivariate test which measures protein expression related to a host/tumor interaction mediated by inflammation. The investigators hope to examine the relationship between quality of life outcomes per FACT-L survey and correlate them with changes in c-reactive protein levels and the VeriStrat® status. The hypothesis of this study is that the remarkable survival benefit in the Temel study is mediated by reduced inflammation with improvement of symptom control.

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival from diagnosis until death from any cause

  Patients will be followed for 5 years after enrolling last patient

Secondary Outcomes (3)

• Percentage of patients who convert from c-reactive protein 'high' (> 10 mg/L) to 'low' (<10 mg/L)

  10 months

• Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups

  10 months

• Change in VeriStrat status

  10 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with metastatic (stage IV) non-small cell lung cancer

You may qualify if:

• Confirmed diagnosis of stage IV non-small cell lung cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Able to read and respond to questions in English

You may not qualify if:

• Small Cell Lung Cancer

Sponsors & Collaborators

• Leo W. Jenkins Cancer Center: lead

Study Sites (1)

Leo Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Retain serum samples draw at baseline, 4 months, 10 months for storage and analysis by Biodesix Laboratories.

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Geoffrey Stroud, PharmD, BCOP, CPP

  Brody School of Medicine at ECU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (1)