Clinical trial · Observational
DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
DECAMP 1 PLUS aims to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules (8-25 mm). Molecular biomarkers for lung cancer diagnosis measured in minimally invasive and non-invasive biospecimens may be able to distinguish between malignant or benign indeterminate pulmonary nodules in high-risk smokers. Ultimately, this study aims to validate molecular as well as clinical and imaging biomarkers of lung cancer in individuals with indeterminate lung nodules.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pulmonary Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biosamples of airway and blood | Other | — | UNRESOLVED |
| Institutional standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1 - Screening
- description
- Participants in this group will be 55-77 years old and currently smoke or were former smokers with 30 pack-years or more (and quit less than 15 years ago)
- interventionNames
- Other: Institutional standard of care
- Other: Biosamples of airway and blood
- label
- Group 2 - Incidental
- description
- Participants in this group will be \> 45 years old and currently smoke or were former smokers with 10 pack-years or more (and quit less than 15 years ago)
- interventionNames
- Other: Institutional standard of care
- Other: Biosamples of airway and blood
Primary outcomes (1)
- measure
- Incidence of lung cancer
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 46 Years
Show eligibility criteria text
Inclusion Criteria: * Radiologic diagnosis of solid indeterminate pulmonary nodule (0.8 to 2.5 cm) identified in the past 3 months OR semi-solid (mixed density) nodule with solid component of at least 0.6 cm identified in the past 12 months; must be of appropriate size at enrollment. * CT scan completed within 3 months prior to enrollment * Able to tolerate all biospecimen collection as required by protocol * Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for approximately three years from enrollment * Able to complete the Patient Lung History questionnaire with study staff Arm 1 - Screening * Age 55-77 years old * Current and former smokers with 30 pack-years or more(and quit less than 15 years ago) Arm 2 - Incidental * Age \> 45 years old * Current and former smokers with 10 pack-years or more(and quit less than 15 years ago) Exclusion Criteria: * History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any other non-lung cancer within 5 years (not including non-melanoma skin cancer) * Symptoms of lung cancer (unexplained weight loss 10 lbs or more in 3 months, recent hemoptysis) * Diagnosis of pure ground glass opacities for the target lesion on chest CT within the last 12 months (i.e., mixed features on the target lesion and pure ground glass opacity on non-target lesions are acceptable as mentioned above)
References
Publications (0)
Data not yet available