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EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Principal Investigator

John C. Ruckdeschel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000064256

NCT ID:

NCT00002667

Start Date:

July 1995

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Ireland Cancer CenterCleveland, Ohio  44106-5065
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Northern New JerseyHackensack, New Jersey  07601
Allegheny University Hospitals- HahnemannPhiladelphia, Pennsylvania  19102-1192