Completed

EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING

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What is being tested

cytology specimen collection procedure

+ immunoenzyme technique

+ study of high risk factors

OtherProcedure
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: October 1995
See protocol details

Summary

Principal SponsorEastern Cooperative Oncology Group
Last updated: June 22, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: October 10, 1995

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Evaluate whether immunostaining of induced sputum specimens improves the sensitivity and specificity of routine morphologic sputum surveillance to detect second primary lung cancer in patients with previously resected nonsmall cell lung cancer. II. Evaluate which patients are at risk of developing a second primary lung cancer by immunostaining specimens from patients with no morphologic atypia on routine Papanicolaou cytology. III. Make available archived sputum samples and bronchial washings for further analysis of new antibodies and techniques. IV. Evaluate whether analysis of elevations of relevant growth factors in bronchial lavage fluid from patients with positive immunostaining or morphologic atypia increases the accuracy of early detection. V. Evaluate whether quantitation of shed antigens in sputum increases the accuracy of early detection. VI. Evaluate whether the extent of airway obstruction, as measured by the forced expiratory volume, can predict an increased risk of developing lung cancer. OUTLINE: Screening for Second Primary Lung Cancer. Annual sputum induction for Papanicolaou cytology and immunostaining (using monoclonal antibodies 624H12 and 703D4), with optional pulmonary function tests and fiberoptic bronchoscopy with bronchial washings. PROJECTED ACCRUAL: 1,100 patients will be entered over 3 years. The sample size will be adjusted based on the rate of positive staining in the first 100 patients. Patients followed at uncertified centers are analyzed separately.

NCT00002667
Principal SponsorEastern Cooperative Oncology Group
Last updated: June 22, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell LungLung Neoplasms

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, United StatesOpen H. Lee Moffitt Cancer Center and Research Institute in Google Maps

CCOP - Iowa Oncology Research Association

Des Moines, United States

CCOP - Northern New Jersey

Hackensack, United States

Ireland Cancer Center

Cleveland, United States
Completed5 Study Centers