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Lung CancerNCT03475420

Post-Treatment Surveillance in Lung Cancer

An observational study of Lung Cancer, run by University of Virginia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are 13.7 million Americans currently living with a history of cancer. With continued improvements in cancer treatment and increasing life expectancy, this number is expected to reach nearly 18 million within the next decade. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
How many people
9,613 participants
Where
No sites listed yet
Study dates
1 Sep 2014to 31 Dec 2016
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: Subjects with lung cancer and data available in the National Cancer Database

Who may be able to join

  • Men or Women
  • Diagnosis of surgically resected lung cancer
  • American Joint Committee On Cancer (AJCC) stages I-III

Who cannot join

  • -

About this study

Official title: Compare Patient-centered Outcomes for Lung Cancer Resection Patients Followed With Alternative Intervals of Surveillance Imaging

There are 13.7 million Americans currently living with a history of cancer. With continued improvements in cancer treatment and increasing life expectancy, this number is expected to reach nearly 18 million within the next decade. The care of these cancer patients, including surveillance during the post-treatment survivorship phase, is an increasingly important major health care concern and expenditure. As the fourth leading diagnosis among cancer survivors, lung cancer is emerging as a chronic problem that currently affects over 450,000 Americans and is expected to grow by nearly 20% by 2022.

Lung cancer is the second most common cancer in the United States. Of the estimated 182,550 patients newly diagnosed with non-small cell lung cancer (NSCLC) this year, approximately 35% will present with localized disease and be eligible for curative resection. For patients with limited NSCLC, surgical resection is the most effective method of controlling the primary tumor and provides the best opportunity for cure. A recent analysis by this group demonstrated that the number of lung cancer resections has increased over the past decade, with over 45,000 lung cancer resections performed annually in the US.

Read more

This research will address a critical gap in knowledge because the optimal approach to post-treatment surveillance following lung cancer resection is unknown. The intensity of recommended surveillance visits ranges from every 3 months during the first two years to an annual visit. Imaging modalities range from CT scans to chest radiographs to no routine imaging for asymptomatic patients. The reason for these significant differences is a lack of quality data on lung cancer surveillance and clinical guidelines based largely on small retrospective analyses and expert opinion.

The National Cancer Data Base (NCDB) provides real world national lung cancer resection and surveillance data on over 70% of newly diagnosed lung cancers from more than 1,500 institutions. This study will compare the effectiveness of the three most common surveillance intensities (CT scans every 3 months vs. 6 months vs. annually) on the stakeholder selected outcome of survival. All analyses will be risk adjusted for differences in patient characteristics at baseline, including tumor characteristics, patient age, comorbid disease, and other potential confounders. Analyses will also be adjusted for the competing risk of death.

Read the detailed description

This study will use a special study of the National Cancer Database to develop a cohort of NSCLC survivors undergoing surveillance. Cox proportional hazards regression and competing risk analyses will compare the effectiveness of the three most common surveillance intensities (3 months vs. 6 months vs. annually) on survival.

There is also a plan to engage cancer survivors to guide the development of our study comparators, outcomes and demonstration of results.

Conditions
Lung Cancer
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03475420
Study groupRoleWhat they receive
National Cancer DatabaseUse existing data to define surveillance strategy in use for patients in this cohort. We will use 10 randomly selected lung cancer resection patients from each accredited institution with stage I-III NSCLC (potentially curative resection) diagnosed in 2006-2007 and with 5 years of complete follow up or reported as deceased before 2012.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Death

    Data elements will include type of surveillance intensity (i.e., 3 month, 6 month or annually) and vital status

    Measured: Subjects with data from 2006-2007 and with 5 years of complete follow-up or reported as deceased before 2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2018
  2. Study start1 Sep 2014
  3. Primary completion31 Dec 2016
  4. Study completion31 Dec 2016

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
9,613 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03475420
Sponsor's protocol ID
17624
Status last verified
Mar 2018
First submitted
23 Jan 2018
Last updated
23 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by University of Virginia.

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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Time to Death (time frame: Subjects with data from 2006-2007 and with 5 years of complete follow-up or reported as deceased before 2012). 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 23 Mar 2018.

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