Post-Treatment Surveillance in Lung Cancer

NCT03475420 | Completed

• 1 other identifier: 17624
• Study Type: observational
• Target: 9,613
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Death

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

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

Study Arms (1)

National Cancer Database

Use 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.

Eligibility Criteria

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

Study Population

Subjects with lung cancer and data available in the National Cancer Database

You may qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead
• Alliance for Clinical Trials in Oncology: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Benjamin Kozower, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 23, 2018
• Study Start: September 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share