Effect of Symptom Management on Inflammation and Survival... | NCT02271581

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

NCT02271581

Sponsor

Leo W. Jenkins Cancer Center

Status

Completed

Last Update Posted

Nov 4, 2020Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Apr 19, 2019Actual

Completion Date

Apr 19, 2019Actual

First Submitted Date

Jul 30, 2014

First Submission Date that Met QC Criteria

Oct 20, 2014

First Posted Date

Oct 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2020

Last Update Posted Date

Nov 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

38Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival from diagnosis until death from any cause	Patients will be followed for 5 years after enrolling last patient

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients who convert from c-reactive protein 'high' (> 10 mg/L) to 'low' (<10 mg/L)	Baseline versus 4 months Baseline versus 10 months 4 months versus 10 months	10 months
Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geoffrey Stroud, PharmD, BCOP, CPP	Brody School of Medicine at ECU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leo Jenkins Cancer Center		Greenville	North Carolina	27834	United States

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided