Cancer screening trials

The purpose of this article is to inform the reader of the "nuts and bolts" of designing and conducting cancer screening RCTs. Following a brief introduction as to why RCTs are critical in evaluating screening modalities, we discuss design considerations, including the choice of design type and duration of follow-up.

Cancer Grand Challenges. Research Program Contacts. Funding Strategy. Grants Policies and Process. Introduction to Grants Process. NCI Grant Policies. Legal Requirements. Step 3: Peer Review and Funding Outcomes. Manage Your Award. Grants Management Contacts. Prior Approvals. Annual Reporting and Auditing. Transfer of a Grant. Grant Closeout.

Cancer Training at NCI. Resources for Trainees. Funding for Cancer Training. Building a Diverse Workforce. National Cancer Act 50th Anniversary Commemoration. Resources for News Media. Media Contacts. Cancer Reporting Fellowships. Advisory Board Meetings. Social Media Events. Cancer Currents Blog. Contributing to Cancer Research.

Strategic Planning. Principal Deputy Director's Page. Previous NCI Directors. NCI Frederick. Advisory Boards and Review Groups. NCI Congressional Justification.

Current Congress. Committees of Interest. Legislative Resources. Recent Public Laws. Menu Contact Dictionary Search. Understanding Cancer. What Is Cancer? Cancer Statistics. Cancer Disparities. Cancer Causes and Prevention. Risk Factors. Cancer Prevention Overview. Cancer Screening Overview.

Screening Tests. Diagnosis and Staging. Questions to Ask about Your Diagnosis. Types of Cancer Treatment. Side Effects of Cancer Treatment. Clinical Trials Information.

A to Z List of Cancer Drugs. Questions to Ask about Your Treatment. Feelings and Cancer. Adjusting to Cancer. Day-to-Day Life. Support for Caregivers. Questions to Ask About Cancer. Choices for Care. Talking to Others about Your Advanced Cancer.

Planning for Advanced Cancer. Advanced Cancer and Caregivers. Questions to Ask about Advanced Cancer. Managing Cancer Care. Finding Health Care Services. As nodule size also correlated with likelihood of cancer, they suggest establishing predictive algorithms to better direct the follow-up for lesions found.

The USPSTF recommendations are targeted at asymptomatic adults aged 55 to 80 years who have a smoking history of at least 30 pack-years and currently smoke or have quit within the previous 15 years. Screening examinations are to be discontinued for any one of the following three reasons: 1 if a person reaches 15 years of not smoking, 2 if a patient develops a severe health problem limiting life expectancy, or 3 if a patient is either unwilling or medically unable to undergo lung surgery with curative intent.

The USPSTF has designated these recommendations grade B, which suggests to providers to offer this service, as it implies a high certainty that the net benefit is moderate.

Table 4 lists the current screening guidelines of the leading professional organizations—all of them largely follow the NLST criteria. Preventive Services Task Force Recommendation. Several studies have examined the NLST data from perspectives relevant for implementation. Stratification of the NLST patients into quintiles, as Bach and Gould have performed, 16 produces two intriguing perspectives. First, the number of participants needed to be screened to prevent 1 lung cancer death—therefore, a measure of benefit to a patient—varies from for the highest risk to for the lowest risk, a fold difference.

Second, a measure of benefit-harm tradeoff in the form of false-positive results per prevented lung cancer death also varied dramatically fold , from to 65 false-positive results per prevented death. Additional subgroup analysis of NLST data also suggests that statistically significant reductions in mortality could be achieved for patients with adenocarcinoma relative risk, 0. Interestingly, these modeling data are what prompted the USPSTF to broaden their target population, beyond the population set out in the NLST, to an upper age limit of 80 years and to recommend a maximum length of screening of 26 years, as opposed to the 3 years of screening in the NLST protocol.

These potential harms, perhaps not surprisingly, play a central role in impeding the progress of broad implementation. These new A or B recommendations may also be applied to private health plans on an annual basis, according to the U.

Department of Health and Human Services. Relevant to the decision of the CMS, however, is further analysis of the data that reveals more nuance in the context of the Medicare patient population. In the wake of the publication of the NLST in , Goulart and colleagues performed an economic analysis of the results. Further economic analysis, this time in the form of an actuarial review, conducted by Pyenson and colleagues also in , 33 framed the discussion with relation to insurance coverage and reimbursement of LDCT screening.

They found that the cost of lung cancer screening depends on various factors, ranging from the number of people screened to the prices charged, the types of screening, and the screening quality.

The authors also qualify their findings by instructing payers and patients to seek screening from high-quality, low-cost providers, which again poses necessary questions for any potential systems-based screening mechanism.

Building on this study, Villanti et al. Just as cost is an important practical consideration, patient adherence must also be thoroughly considered for any implementation of a screening program. The lessons from colon cancer screening show that follow-up is difficult in patients at the highest risk of developing disease. Accordingly, the USPSTF advocates for organized screening programs that include smoking cessation counseling when applicable, standardized scanning and image interpretation, quality standardization, and registry participation and validation, to ensure that LDCT screening achieves results similar to those of the NLST.

Screening protocols have become integrated as a standard of care for several solid tumor malignancies, including colon, prostate, and breast cancer. However, because of concerns about the cost and potential complications associated with false positive screens, particularly in the elderly population, approval for LDCT lung cancer screening by CMS is lacking. As a result, the future of lung cancer screening remains elusive in the current political and social climate.

The United States Preventative Services Task Force recommends screening high-risk individuals aged 55 to 80 years with annual low-dose computed tomography. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript.

The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. All authors declare no conflicts of interest and have no disclosures to make. National Center for Biotechnology Information , U.

Thorac Surg Clin. Author manuscript; available in PMC May 1. Neel P. Chudgar , M. Bucciarelli , M. Jeffries , Nabil P. Rizk , M. Park , M. Adusumilli , M.

Jones , M. Author information Copyright and License information Disclaimer. Address correspondence to: David R.