Cancer Screening for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Must not be taking: Proscar, Propecia, Finasteride

Disqualifiers: Cancer treatment, Prior PLCO cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

154901 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, men who are taking finasteride or Tamoxifen, and women who are taking Tamoxifen or Evista/Raloxifene, are allowed to participate.

What data supports the effectiveness of the treatment X-Ray Imaging, Radiography, X-Ray Radiography for lung cancer screening?

Research suggests that early diagnosis of lung cancer through chest radiographs can lead to better outcomes, as early detection allows for more effective treatment. However, while survival rates may improve with early detection, there is no clear evidence that it reduces overall mortality rates. ^{1 2 3 4 5}

Is lung cancer screening with X-Ray Imaging safe for humans?

Lung cancer screening with low-dose CT scans, which is similar to X-Ray Imaging, has been shown to have very low risks from radiation exposure. While there are potential harms like anxiety and overdiagnosis, the overall risks are considered low, and the benefits often outweigh these concerns. ^{6 7 8 9 10}

How does X-Ray Imaging differ from other treatments for lung cancer?

X-Ray Imaging for lung cancer screening is unique because it involves using radiographs (X-ray pictures) to detect tumors early, often before symptoms appear, which can help identify smaller tumors in asymptomatic patients. However, its effectiveness in improving survival rates is uncertain, and it is not currently recommended as a standard screening method for lung cancer. ^{1 11 12 13 14}

What is the purpose of this trial?

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for lung cancer.

Research Team

Christine D Berg

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for older individuals who may be at risk of lung cancer. Participants will undergo screening methods to detect any signs of cancer early on, which could lead to better treatment outcomes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lung Screening

Participants undergo a chest x-ray at baseline and annually for 2 years, with additional x-ray at year 3 for smokers

3 years

Annual visits for chest x-ray

Follow-up

Participants are monitored for lung cancer incidence and mortality for at least 13 years

13 years

Annual follow-up via mailed questionnaire

Treatment Details

Interventions

• X-Ray Imaging

Trial Overview The study is testing the effectiveness of a screening questionnaire and X-ray imaging in identifying lung cancer in its early stages, with the goal of reducing mortality from this disease.

Participant Groups

Group I: Lung Screening Active Control 2 Interventions

Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3. Participants complete a BQF/M at baseline. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident lung cancers as all deaths that occur among both screened and control subjects during the trial.

Group II: Control Active Control 1 Intervention

Participants receive standard medical care. Participants complete a DHQ at baseline.

X-Ray Imaging is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in United States as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in Canada as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in Japan as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in China as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in Switzerland as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

A patient decision aid (PDA) significantly improved smokers' preparedness for making decisions about lung cancer screening compared to standard educational materials, with 67.4% of PDA users feeling well-prepared versus 48.2% of those using standard education.

Participants using the PDA reported feeling more informed and clearer about their values regarding the benefits and harms of screening, but there was no difference in actual screening intentions or behaviors between the PDA and standard education groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial. Volk, RJ., Lowenstein, LM., Leal, VB., et al.[2021]

Lung cancer screening using low-dose chest CT scans can significantly reduce lung cancer mortality in a very high-risk group, highlighting its efficacy as a preventive measure.

Successful implementation of lung cancer screening programs requires addressing 11 identified obstacles, emphasizing the need for a multi-disciplinary approach and viewing screening as a comprehensive program rather than just a single test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstacles to and Solutions for a Successful Lung Cancer Screening Program. Mazzone, PJ.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Screening by chest radiograph and lung cancer mortality: the Prostate, Lung, Colorectal, and Ovarian (PLCO) randomized trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Validation of a Deep Learning Algorithm for the Detection of Malignant Pulmonary Nodules in Chest Radiographs. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Outcome in patients with lung cancer found on lung cancer mass screening roentgenograms, but who did not subsequently consult a doctor. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Assessing the use of digital radiography and a real-time interactive pulmonary nodule analysis system for large population lung cancer screening. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Prognosis of patients with lung cancer found in a single chest radiograph screening. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Radiation risk of lung cancer screening. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Obstacles to and Solutions for a Successful Lung Cancer Screening Program. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening. [2021]

10. China pubmed.ncbi.nlm.nih.gov

Ability of three-dimensional 3-Tesla ultrashort echo time magnetic resonance imaging to display the morphological characteristics of pulmonary nodules: a sensitivity analysis. [2023]

11. Italy pubmed.ncbi.nlm.nih.gov

[Radiological mass screening in pulmonary cancer. Is it useful in improving the prognosis?]. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Screening for lung cancer in a fixed population by biennial chest radiography. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Screening for lung cancer: An evidence-based synthesis. [2005]

14. United States pubmed.ncbi.nlm.nih.gov

Advances in sputum analysis for screening and early detection of lung cancer. [2017]