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

July 1, 2016 updated by: Alliance for Clinical Trials in Oncology

Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • Concord, California, United States, 94524-4110
        • John Muir/Mount Diablo Cancer Center - Concord Campus
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Glendale, California, United States, 91204
        • Glendale Memorial Hospital Comprehensive Cancer Center
      • Loma Linda, California, United States, 92357
        • Veterans Affairs Medical Center - Loma Linda (Pettis)
      • Roseville, California, United States, 95661
        • Sutter Cancer Center at Roseville Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Cancer center
      • Walnut Creek, California, United States, 94598
        • John Muir/Mt. Diablo Comprehensive Cancer Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Praxair Cancer Center at Danbury Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
    • Georgia
      • Altanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Augusta, Georgia, United States, 30912
        • MBCCOP-Medical College of Georgia Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Springfield, Illinois, United States, 62702
        • Cancer Institute at St. John's Hospital
      • Springfield, Illinois, United States, 62794-9620
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62781
        • Regional Cancer Center at Memorial Medical Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Richmond, Indiana, United States, 47374
        • Reid Hospital & Health Care Services, Incorporated
    • Kentucky
      • Louisville, Kentucky, United States, 40202-1886
        • Jewish Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • New Jersey
      • Trenton, New Jersey, United States, 08629
        • Fox Chase Cancer Center at St. Francis Medical Center
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Kingston, New York, United States, 12401
        • Benedictine Hospital
      • Oceanside, New York, United States, 11572
        • South Nassau Communities Hospital
      • Stony Brook, New York, United States, 11794-8174
        • Stony Brook University Cancer Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center at Altru Hospital
    • Ohio
      • Akron, Ohio, United States, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Cincinnati, Ohio, United States, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45220
        • Cancer Treatment Center at Good Samaritan Hospital
      • Dayton, Ohio, United States, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
      • Kettering, Ohio, United States, 45429
        • Charles F. Kettering Memorial Hospital
      • Middletown, Ohio, United States, 45044
        • Middletown Regional Hospital
      • Troy, Ohio, United States, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Xenia, Ohio, United States, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • New Castle, Pennsylvania, United States, 16105
        • Jameson Memorial Hospital - North Campus
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15240
        • Veterans Affairs Medical Center - Pittsburgh
      • Pittsburgh, Pennsylvania, United States, 15224-1791
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920-6999
        • U.T. Cancer Institute at University of Tennessee Medical Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
    • Washington
      • Seattle, Washington, United States, 98114
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-small cell lung cancer patients

Description

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 Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery + blood and serum collection

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David H. Harpole, MD, Duke Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 10, 2004

First Submitted That Met QC Criteria

February 11, 2004

First Posted (Estimate)

February 12, 2004

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACOSOG-Z4031
  • CDR0000350123 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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