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

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00077324
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-02-10
• Study First Submitted QC: 2004-02-11
• Study First Posted: 2004-02-12
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine whether the serum proteomic profile can predict the presence of primary lung cancer in patients with suspicious lung lesions	Up to 5 years
Survival	Up to 5 years

Trial Locations

Locations (73)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

John Muir/Mount Diablo Cancer Center - Concord Campus; 🇺🇸 Concord, California, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Glendale Memorial Hospital Comprehensive Cancer Center; 🇺🇸 Glendale, California, United States

Veterans Affairs Medical Center - Loma Linda (Pettis); 🇺🇸 Loma Linda, California, United States

Sutter Cancer Center at Roseville Medical Center; 🇺🇸 Roseville, California, United States

Sutter Cancer Center; 🇺🇸 Sacramento, California, United States

John Muir/Mt. Diablo Comprehensive Cancer Center; 🇺🇸 Walnut Creek, California, United States

Praxair Cancer Center at Danbury Hospital; 🇺🇸 Danbury, Connecticut, United States

George Washington University Medical Center; 🇺🇸 Washington, District of Columbia, United States

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