NCT00002667

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Oct 1995

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 1995

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

July 19, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

9 years

First QC Date

November 1, 1999

Last Update Submit

June 20, 2023

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer

Interventions

cytology specimen collection procedureOTHER
immunoenzyme techniqueOTHER
study of high risk factorsPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 10309-1016, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Allegheny University Hospitals- Hahnemann

Philadelphia, Pennsylvania, 19102-1192, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

ImmunoassayImmunologic TechniquesInvestigative TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • John C. Ruckdeschel, MD

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

  • Paul A. Bunn, MD

    University of Colorado, Denver

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SCREENING
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 19, 2004

Study Start

October 10, 1995

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

US(5)