Lung NeoplasmsNCT02271581
Effect of Symptom Management on Inflammation and Survival in Metastatic Lung Cancer
An observational study of Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Leo W. Jenkins Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 19 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with metastatic (stage IV) non-small cell lung cancer
Who may be able to join
- 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
Who cannot join
- Small Cell Lung Cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Leo Jenkins Cancer Center
Greenville, North Carolina, 27834
About this study
Official 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
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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival from diagnosis until death from any cause
Measured: 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)
- Baseline versus 4 months
- Baseline versus 10 months
- 4 months versus 10 months
Measured: 10 months
Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups
- 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)
Measured: 10 months
Change in VeriStrat status
Percentage of patients who convert from "poor" to "good"
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leo W. Jenkins Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey Stroud, PharmD, BCOP, CPP, Principal investigator, Brody School of Medicine at ECU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271581
- Sponsor's protocol ID
- INSYNC
- Status last verified
- Nov 2020
- First submitted
- 30 Jul 2014
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02271581
- Acronym / sponsor ID
- INSYNC
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Leo W. Jenkins Cancer CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with metastatic (stage IV) non-small cell lung cancer
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Small Cell Lung Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: Patients will be followed for 5 years after enrolling last patient
Overall survival from diagnosis until death from any cause
3 secondary outcomes
Percentage of patients who convert from c-reactive protein 'high' (> 10 mg/L) to 'low' (<10 mg/L)
Time frame: 10 months
Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups
Time frame: 10 months
Change in VeriStrat status
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey Stroud, PharmD, BCOP, CPP principal investigator
Brody School of Medicine at ECU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Leo W. Jenkins Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Patients will be followed for 5 years after enrolling last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.