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CompletedNCT00077324Updated Jul 6, 2016

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

An observational study in Lung Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 73 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-06.

Sponsored by Alliance for Clinical Trials in Oncology · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Lung Cancer

Keywords

  • stage I non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 1,000 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Non-small cell lung cancer patients

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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

Interventions

  • Geneticproteomic profiling
  • Othersurface-enhanced laser desorption/ionization-time of flight mass spectrometry
  • Procedurebiopsy
  • Proceduresurgery
06

What researchers measure

Primary outcomes

  1. 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

  2. Survival

    Time frame: Up to 5 years

07

Study locations

73 sites
  • University of Alabama at Birmingham Comprehensive Cancer Center
    Birmingham, Alabama 35294, United States
  • John Muir/Mount Diablo Cancer Center - Concord Campus
    Concord, California 94524-4110, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
  • Glendale Memorial Hospital Comprehensive Cancer Center
    Glendale, California 91204, United States
  • Veterans Affairs Medical Center - Loma Linda (Pettis)
    Loma Linda, California 92357, United States
  • Sutter Cancer Center at Roseville Medical Center
    Roseville, California 95661, United States
  • Sutter Cancer Center
    Sacramento, California 95816, United States
  • John Muir/Mt. Diablo Comprehensive Cancer Center
    Walnut Creek, California 94598, United States
  • Praxair Cancer Center at Danbury Hospital
    Danbury, Connecticut 06810, United States
  • George Washington University Medical Center
    Washington, District of Columbia 20037, United States
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
  • Winship Cancer Institute of Emory University
    Altanta, Georgia 30322, United States
  • MBCCOP-Medical College of Georgia Cancer Center
    Augusta, Georgia 30912, United States
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    Chicago, Illinois 60611-3013, United States
  • Cancer Institute at St. John's Hospital
    Springfield, Illinois 62702, United States
  • Regional Cancer Center at Memorial Medical Center
    Springfield, Illinois 62781, United States
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62794-9620, United States
  • St. Francis Hospital and Health Centers - Beech Grove Campus
    Beech Grove, Indiana 46107, United States
  • Reid Hospital & Health Care Services, Incorporated
    Richmond, Indiana 47374, United States
  • Jewish Hospital
    Louisville, Kentucky 40202-1886, United States
  • Greater Baltimore Medical Center Cancer Center
    Baltimore, Maryland 21204, United States
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
  • William Beaumont Hospital - Royal Oak Campus
    Royal Oak, Michigan 48073, United States
  • Veterans Affairs Medical Center - Minneapolis
    Minneapolis, Minnesota 55417, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • Siteman Cancer Center at Barnes-Jewish Hospital
    St Louis, Missouri 63110, United States
  • Fox Chase Cancer Center at St. Francis Medical Center
    Trenton, New Jersey 08629, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
  • Benedictine Hospital
    Kingston, New York 12401, United States
  • South Nassau Communities Hospital
    Oceanside, New York 11572, United States
  • Stony Brook University Cancer Center
    Stony Brook, New York 11794-8174, United States
  • SUNY Upstate Medical University Hospital
    Syracuse, New York 13210, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • Rutherford Hospital
    Rutherfordton, North Carolina 28139, United States
  • Altru Cancer Center at Altru Hospital
    Grand Forks, North Dakota 58201, United States
  • McDowell Cancer Center at Akron General Medical Center
    Akron, Ohio 44307, United States
  • Cancer Treatment Center at Good Samaritan Hospital
    Cincinnati, Ohio 45220, United States
  • Bethesda North Hospital
    Cincinnati, Ohio 45242, United States
  • Charles M. Barrett Cancer Center at University Hospital
    Cincinnati, Ohio 45267, United States
  • Grandview Hospital
    Dayton, Ohio 45405, United States
  • Good Samaritan Hospital
    Dayton, Ohio 45406, United States
  • Samaritan North Cancer Care Center
    Dayton, Ohio 45415, United States
  • Veterans Affairs Medical Center - Dayton
    Dayton, Ohio 45428, United States
  • CCOP - Dayton
    Dayton, Ohio 45429, United States
  • Charles F. Kettering Memorial Hospital
    Kettering, Ohio 45429, United States
  • Middletown Regional Hospital
    Middletown, Ohio 45044, United States
  • UVMC Cancer Care Center at Upper Valley Medical Center
    Troy, Ohio 45373-1300, United States
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    Xenia, Ohio 45385, United States
  • Rosenfeld Cancer Center at Abington Memorial Hospital
    Abington, Pennsylvania 19001, United States
  • Jameson Memorial Hospital - North Campus
    New Castle, Pennsylvania 16105, United States
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
  • Allegheny Cancer Center at Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    Pittsburgh, Pennsylvania 15224-1791, United States
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
    Pittsburgh, Pennsylvania 15232, United States
  • Veterans Affairs Medical Center - Pittsburgh
    Pittsburgh, Pennsylvania 15240, United States
  • Lankenau Cancer Center at Lankenau Hospital
    Wynnewood, Pennsylvania 19096, United States
  • Rhode Island Hospital Comprehensive Cancer Center
    Providence, Rhode Island 02903, United States
  • Miriam Hospital
    Providence, Rhode Island 02906, United States
  • AnMed Health Cancer Center
    Anderson, South Carolina 29621, United States
  • Hollings Cancer Center at Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • CCOP - Upstate Carolina
    Spartanburg, South Carolina 29303, United States
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    Spartanburg, South Carolina 29303, United States
  • U.T. Cancer Institute at University of Tennessee Medical Center
    Knoxville, Tennessee 37920-6999, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232, United States
  • LDS Hospital
    Salt Lake City, Utah 84143, United States
  • University of Virginia Cancer Center
    Charlottesville, Virginia 22908, United States
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
    Seattle, Washington 98114, United States
  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    Morgantown, West Virginia 26506, United States
  • Green Bay Oncology, Limited at St. Vincent Hospital
    Green Bay, Wisconsin 54301-3526, United States
  • Green Bay Oncology, Limited at St. Mary's Hospital
    Green Bay, Wisconsin 54303, United States
  • St. Mary's Hospital Medical Center - Green Bay
    Green Bay, Wisconsin 54303, United States
  • St. Vincent Hospital Regional Cancer Center
    Green Bay, Wisconsin 54307-3508, United States
  • Toronto General Hospital
    Toronto, Ontario M5G 2C4, Canada
08

References and documents

Publications

  • Harpole DH, Meyerson SL. Lung cancer staging: proteomics. Thorac Surg Clin. 2006 Nov;16(4):339-43. doi: 10.1016/j.thorsurg.2006.10.001. PubMed 17240821 ↗
  • Grogan EL, Deppen SA, Ballman KV, et al.: Accuracy of FDG-PET to diagnose lung cancer in the ACOSOG Z4031 trial. [Abstract] J Clin Oncol 30 (Suppl 15): A-7008, 2012.
  • Harpole D, Ballman KV, Oberg AL, et al.: Proteomic analysis for detection of NSCLC: results of ACOSOG Z4031. [Abstract] J Clin Oncol 29 (Suppl 15): A-7003, 2011.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00077324
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 12, 2004
Start date
Feb 2004
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Jul 6, 2016

Study contacts

David H. Harpole, MD
study chair · Duke Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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