Browse EPPT > MDA2013-01-01
A Randomized Phase II Trial of Low Dose Aspirin Versus Placebo in High-Risk Individuals With CT-Detected Subsolid Lung Nodules

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

Files	Description
Data Dictionary (PDF - 789.8 KB)	1. The Enhanced Person dataset contains all information relevant for most analyses. Each record represents one participant and contains updated variable names, formats, and labels. All information coming from non-person-based datasets has been converted into a person-based format.
Data Dictionary (PDF - 172.8 KB)	2. The Adverse Events dataset includes updated variable names, formats, and labels.

Raw Datasets

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

Show these datasets

Files	Description
Data Dictionary (PDF - 172.8 KB)	1. The adverseevents dataset contains adverse event information
Data Dictionary (PDF - 161.8 KB)	2. The aeandconmedeval dataset contains concomitant medication and adverse event information
Data Dictionary (PDF - 163.3 KB)	3. The agentinterrupt dataset contains agent interruption reasons and details
Data Dictionary (PDF - 166.7 KB)	4. The agentmodification dataset contains agent modification reasons and details
Data Dictionary (PDF - 166.7 KB)	5. The basemedsurghist dataset contains medical and surgical histories of body systems
Data Dictionary (PDF - 161.7 KB)	6. The basesymptoms dataset contains symptoms experienced at baseline
Data Dictionary (PDF - 173.3 KB)	7. The bioptissuehist dataset contains tissue biopsy information
Data Dictionary (PDF - 165.0 KB)	8. The bloodchemistry dataset contains blood chemistry test resuslts
Data Dictionary (PDF - 164.3 KB)	9. The bloodspecimen dataset contains blood specimen results
Data Dictionary (PDF - 159.7 KB)	10. The comments dataset contains general comments
Data Dictionary (PDF - 173.9 KB)	11. The compliance dataset contains general study compliance information
Data Dictionary (PDF - 161.6 KB)	12. The compliancedruglabels dataset contains agent compliance information
Data Dictionary (PDF - 172.1 KB)	13. The compliancephoneinterview dataset contains phone interview compliance information
Data Dictionary (PDF - 164.5 KB)	14. The conmeds dataset contains concomitant medication information
Data Dictionary (PDF - 172.5 KB)	15. The ctscannewlesions dataset contains CT scan new lesions information
Data Dictionary (PDF - 166.8 KB)	16. The ctscannontargetlesions dataset contains CT scan non-target lesions information
Data Dictionary (PDF - 166.8 KB)	17. The ctscannontargetlesionsv12 dataset contains CT scan non-target lesions information
Data Dictionary (PDF - 167.0 KB)	18. The ctscannontargetmth3_6_12 dataset contains CT scan non-target lesions information for month 3, 6, and 12
Data Dictionary (PDF - 166.8 KB)	19. The ctscannontargetv12mth3_6_12 dataset contains CT scan non-target lesions information for month 3, 6, and 12
Data Dictionary (PDF - 168.3 KB)	20. The ctscantargetlesions dataset contains CT scan target lesions information
Data Dictionary (PDF - 169.0 KB)	21. The ctscantargetlesionsv14 dataset contains CT scan target lesions information
Data Dictionary (PDF - 168.5 KB)	22. The ctscantargetmth3_6_12 dataset contains CT scan target lesions information for month 3, 6, and 12
Data Dictionary (PDF - 170.1 KB)	23. The ctscantargetv14mth3_6_12 dataset contains CT scan target lesions information for month 3, 6, and 12
Data Dictionary (PDF - 161.7 KB)	24. The demographics dataset contains participant demographics information
Data Dictionary (PDF - 162.0 KB)	25. The eligibilityverification dataset contains participant eligibility verification information
Data Dictionary (PDF - 161.1 KB)	26. The exclusioncriteriaprev12 dataset contains exclusion criteria information
Data Dictionary (PDF - 160.1 KB)	27. The exclusioncriteriav12 dataset contains exclusion criteria information
Data Dictionary (PDF - 161.9 KB)	28. The finalctscansummaryv12_06212016 dataset contains final CT scan summary information
Data Dictionary (PDF - 165.0 KB)	29. The hematology1 dataset contains contains hematology test results
Data Dictionary (PDF - 164.9 KB)	30. The hematology2 dataset contains contains hematology test results
Data Dictionary (PDF - 160.0 KB)	31. The inclusioncriteriaprev8 dataset contains inclusion criteria information
Data Dictionary (PDF - 160.1 KB)	32. The inclusioncriteriav12 dataset contains inclusion criteria information
Data Dictionary (PDF - 160.1 KB)	33. The inclusioncriteriav13 dataset contains inclusion criteria information
Data Dictionary (PDF - 159.6 KB)	34. The inclusioncriteriav8 dataset contains inclusion criteria information
Data Dictionary (PDF - 162.3 KB)	35. The interventionadmin dataset contains intervention and admin information
Data Dictionary (PDF - 163.4 KB)	36. The mirna dataset contains miRNA information and results
Data Dictionary (PDF - 165.5 KB)	37. The offstudy dataset contains information about when and why a participant exited the study
Data Dictionary (PDF - 163.7 KB)	38. The otherlabtests dataset contains information about other lab tests that were performed
Data Dictionary (PDF - 178.8 KB)	39. The physicalexam dataset contains anthropometry and physical examination information of different body systems
Data Dictionary (PDF - 164.0 KB)	40. The pregnancyspecimendata dataset contains pregnancy test information and results
Data Dictionary (PDF - 168.9 KB)	41. The randomization dataset contains general information pertinent to the participants randomization
Data Dictionary (PDF - 174.4 KB)	42. The registration dataset contains participant registration information
Data Dictionary (PDF - 164.0 KB)	43. The researchblood dataset contains blood test sample information
Data Dictionary (PDF - 164.1 KB)	44. The researchbloodmonth6 dataset contains blood test sample information
Data Dictionary (PDF - 164.0 KB)	45. The researchurine dataset contains urine test sample information
Data Dictionary (PDF - 164.2 KB)	46. The researchurinemonth6 dataset contains urine test sample information
Data Dictionary (PDF - 162.3 KB)	47. The telephonecontact dataset contains telephone contact information
Data Dictionary (PDF - 183.1 KB)	48. The tobaccoassessment dataset contains results of the tobacco assessment
Data Dictionary (PDF - 165.8 KB)	49. The unblind dataset contains study unblinding information
Data Dictionary (PDF - 163.3 KB)	50. The urinespecimen dataset contains urine specimen results
Data Dictionary (PDF - 159.8 KB)	51. The verification dataset contains participant verification information

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