The following datasets contain the data available for EPPT MDA2013-01-01. The description and documentation for each file is listed below. SAS7bdat and CSV versions of the actual data will be available to CDAS projects approved to use this study's data.

Analysis Datasets

Raw Datasets

These 51 datasets contain the raw form data received, excluding PII.

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Trial Summary

This study was performed to determine the effect of low dose aspirin on subsolid (non-solid or partially solid) lung nodules. 98 volunteers were randomized and 89 completed the study. Compliance to the treatment was high with a 76% adherence through the trial.

Aspirin was administered to the volunteers in a dose of 100mg tablet every day or matched placebo for 1 year.

The study concluded that there is no effect of low dose aspirin on the sum of diameters, volume, or density of target lesions. Urinary PGEM was significantly reduced by the low dose aspirin treatment, Thromboxane B2 is a reliable biomarker for assessing compliance, and one year of treatment with low dose aspirin is well tolerated by healthy at risk subjects.

Randomized trial with two arms:

• Arms
  • Arm I: Aspirin (acetylsalicylic acid) 100 mg tablet daily for 1 year.
  • Arm II: Placebo 100 mg tablet daily for 1 year.

Enrollment Statistics

Expected Enrollment: 128

Actual Enrollment: 109

• 98 participants randomized
  • 11 not randomized (ineligible, non-persistency of target nodule, comorbidity or concomitant medications)
• 45 aspirin compliance measured by thromboxane at 6 months (45 of 49)
• 37 aspirin compliance measured by thromboxane at 12 months (37 of 49)

Total Study Population Demographics (98 Randomized and Eligible People):

• Age (years):
  • Mean: 64.7
  • Range: 57 - 78
  • Median: 65
• Height (cm):
  • Mean: 168
  • IQR: 160 - 173
  • Range: 150 - 197
  • Median: 168
• Weight (kg):
  • Mean: 69
  • IQR: 60 - 79
  • Range: 14 - 101
  • Median: 68
• Sex
  • Females: 55 (56.1%)
  • Males: 43 (43.9%)

Final Analysis Population: 98

Eligibility Criteria

Inclusion Criteria

• Asymptomatic current or former smokers (having stopped within the last 20 years)
• Smoking history >= 20 pack/years; subjects must be included in an ongoing annual screening with low dose CT scan or must have two consecutive CT outside the context of a screening program confirming subsolid nodules
• Subjects must have subsolid (non-solid or partially solid) nodules with size between 4 and 10 mm with any volume doubling time (VDT) not candidate to surgical excision and/or subsolid (non solid or partially solid) nodule larger than 10 mm with VDT higher than 400 days and not candidate to surgical excision
• All nodules should be persistent at least after three months follow up with 1 dimension (1d)-CT; a reduction up to 15% of the diameter of the largest target nodule from the previous CT scan is allowed
• All current smokers should accept to receive support for smoking cessation
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
• Leukocytes >= 3,000/microliter
• Absolute neutrophil count >= 1,500/microliter
• Platelets >= 100,000/microliter
• Total bilirubin =< 2 X institutional upper limit of normal (ULN) and/or history of Gilbert's syndrome
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional ULN
• Serum creatinine =< institutional ULN
• Women of child-bearing potential (from first menstruation to 1 year after last menstruation) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
• Ability to understand and the willingness to sign a written informed consent document
• Signed informed consent

Exclusion Criteria

• Subjects with chronic treatment (at least twice/week for more than 3 months) with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
• History of allergic reactions attributed to compounds of similar chemical or biological composition to aspirin, NSAIDs, cyclooxygenase-2 (COX2) inhibitors
• Invasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization; stage I-II invasive malignancies that were diagnosed more than 2 years prior to randomization and have been treated curatively are allowed as long as all treatment is finished at least 18 months prior to randomization
• History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolisms) in the preceding year
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with aspirin
• Individual may not be receiving any other investigational agents, antiplatelet agents (e.g. aspirin, clopidogrel [Plavix or others]), anticoagulants (e.g. heparin or heparinoids, Coumadin, or others), methotrexate, lithium
• Participants with bleeding diathesis, history of gastric/duodenal ulcers in the last 5 years, NSAID-precipitated bronchospasm, patients unwilling or unable to limit alcohol consumption to i.e. =< 3 alcohol drinks a day
• Participants who in the opinion of the principal investigator (PI) will be at higher risk of acetylsalicylic acid (ASA)-related complications
• Participants with known inability to adequately absorb oral medication

The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.

Study Schema