Clinical trial · Interventional
Sputum Cytology in Screening Heavy Smokers For Lung Cancer
Lung Cancer Screening and Tissue Procurement
NCT00103363CI-TRIAL-00014440completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early and plan better treatment for lung cancer. PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy smokers for lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| annual screening | Procedure | — | UNRESOLVED |
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| physiologic testing | Other | — | UNRESOLVED |
| study of high risk factors | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Classification of annual sputum samples cytologically
- measure
- Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence
- measure
- Correlation of changes in sputum cytology with lung cancer incidence
Secondary outcomes (1)
- measure
- Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Current or ex-smoker with a lifetime history of cigarette smoking of ≥ 20 pack years, meeting 1 of the following criteria:
* Airflow obstruction
* FEV\_1 \< 75% predicted for age by spirometry
* FEV\_1/FVC ≤ 75% by spirometry
* No airflow obstruction
* No history of lung cancer
PATIENT CHARACTERISTICS:
Age
* 25 and over
Performance status
* Not specified
Life expectancy
* More than 5 years
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No cancer within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.