Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: surgery; Procedure: biopsy; Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry; Genetic: proteomic profiling

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00077324

ACOSOG-Z4031

CDR0000350123 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Evaluating specific proteins in the blood may be an effective and noninvasive procedure to help doctors determine if a patient has early non-small cell lung cancer.

PURPOSE: This clinical trial is studying proteomic profiling to see how well it works in diagnosing non-small cell lung cancer in patients who are undergoing resection for suspicious (abnormal) stage I lung lesions.

Full description

OBJECTIVES:

Primary

• Determine, prospectively, whether serum proteomic profiling can predict the presence of primary non-small cell lung cancer in patients with clinically suspicious stage I lung lesions who are undergoing lung resection.

Secondary

• Correlate the serum proteomic profile with pathologic nodal status and histopathologic features of primary lung cancer in these patients.
• Correlate the initial and follow-up serum proteomic profile with overall and cancer-specific survival of these patients.
• Correlate changes in the proteomic profile (preoperative to postoperative) with overall and cancer-specific survival of these patients.

Tertiary

• Determine whether novel molecular strategies can predict the presence of lung cancer and/or the biologic behavior of an individual cancer in these patients.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient must be ≥18 years of age.

2. Patient must have a clinically suspicious stage I (cT1-2 N0 M0) lung lesion.

3. Patient must have pre-operative imaging procedures within 60 days prior to the date of the lung resection: Helical CT scan of the chest and CT scan of the upper abdomen, including the liver and adrenal glands (with or without IV contrast), as clinically indicated. The helical CT must rule out metastatic disease in the liver and adrenal glands.

4. Patient, or the patient's legally acceptable representative, must provide a signed and dated written informed consent PRIOR to registration and any study-related procedures being performed.

5. Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient PRIOR to registration and any study-related procedures being performed.

6. If patient is a survivor of a prior cancer, the following criteria are met:

   1. Patient has undergone potentially curative therapy for all prior malignancies,
   2. No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),
   3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Exclusion criteria

1. Patient has undergone previous lung resection within the preceding 30 days.
2. Patient has received prior chemotherapy or radiotherapy.
3. Patient has had a blood product transfusion of any kind within the past 60 days of the operative procedure.

Trial design

1,000 participants in 1 patient group

Surgery + blood and serum collection

Description:

Patients undergo lung resection. Patients also undergo preoperative and postoperative collection of whole blood and serum for proteomic profiling using surface-enhanced laser desorption/ionization-time of flight mass spectrometry. A lung tissue biopsy taken at surgery is also analyzed. Patients are followed at 60-90 days and then annually for 2-5 years.

Treatment:

Procedure: surgery

Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry

Genetic: proteomic profiling

Procedure: biopsy