CompletedNot applicableNCT00002667
Official study title

Early Detection of Second Lung Cancer in Patients With Stage I Non-small Cell Lung Cancer

Study summary

RATIONALE: Using new methods to examine sputum samples for the presence of cancer cells may detect lung cancer earlier. PURPOSE: Screening trial to study the effectiveness of new methods of examining sputum samples to detect second primary lung cancer in patients with resected stage I non-small cell lung cancer.

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Key things to know

Main goalScreening

This describes the study’s primary purpose.

What is being studiedcytology specimen collection procedure and immunoenzyme technique

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 22, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Eastern Cooperative Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Screening
Study type
Interventional
Phase
Not applicable
Sponsor
Eastern Cooperative Oncology Group
Interventions being studied
Other: cytology specimen collection procedure; Other: immunoenzyme technique; Procedure: study of high risk factors
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

DISEASE CHARACTERISTICS: Stage I (T1-2 N0) nonsmall cell lung cancer curatively resected and in regular follow-up for at least 6 weeks Material available for histologic review At least 1 mediastinal node station sampled or at least 2 years since surgery Any of the following histologies eligible: Squamous cell carcinoma Large cell carcinoma Adenocarcinoma (including bronchoalveolar) No small cell anaplastic component No recurrent disease or second primary No synchronous lung cancer of a different histology Concurrent registration on intergroup protocol I91-0001 allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Cardiovascular: No history of severe hypertension, i.e.: Systolic 200 mm Hg or more Diastolic 120 mm Hg or more No MI within 6 weeks Pulmonary: Available for annual sputum induction and clinical evaluation Clinically able to undergo pulmonary function tests (PFTs) and bronchoscopy Refusal of PFTs or bronchoscopy will not effect eligibility PFTs waived if FEV1/FVC \< 65% on prior testing No acute respiratory infection Other: No prior uncontrolled malignancy except nonmelanomatous skin cancer Exceptions for malignancy controlled more than 5 years discretionary PRIOR CONCURRENT THERAPY: Complete surgical resection required as primary therapy At least 6 weeks since resection, any adjuvant chemotherapy or radiotherapy, or thoracoabdominal surgery

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida
  • CCOP - Iowa Oncology Research AssociationDes Moines, Iowa
  • CCOP - Northern New JerseyHackensack, New Jersey
  • Ireland Cancer CenterCleveland, Ohio
  • Allegheny University Hospitals- HahnemannPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 22, 2023. Always confirm current availability with the study team.

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