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OpenTrials
Completed

NCT Number: NCT02271581

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

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.

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Key information

Conditions

Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leo Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Small Cell Lung Cancer

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: Patients will be followed for 5 years after enrolling last patient

    Overall survival from diagnosis until death from any cause

Secondary outcomes

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

    Time frame: 10 months

    • Baseline versus 4 months
    • Baseline versus 10 months
    • 4 months versus 10 months

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

    Time frame: 10 months

    • VeriStrat "Good" and CRP "low" (<10 mg/L)
    • VeriStrat "Good" and CRP "high" (>10 mg/L)
    • VeriStrat "Poor" and CRP "low" (<10 mg/L)
    • VeriStrat "Poor" and CRP "high" (>10 mg/L)

  3. Change in VeriStrat status

    Time frame: 10 months

    Percentage of patients who convert from "poor" to "good"

Sponsors and collaborators

Lead sponsor

Leo W. Jenkins Cancer Center

Other

Registry information

Official study title

INSYNC: Leo Jenkins Cancer Center (LJCC) - Symptom Management Service (SMS) Protocol -Phase II Trial Regarding The Effect Of Comprehensive Symptom Management On Inflammation And Survival In Metastatic Lung Cancer

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2014
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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