Lung CancerNCT00077324
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 of Lung Cancer, run by Alliance for Clinical Trials in Oncology at 73 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- proteomic profiling, surface-enhanced laser desorption/ionization-time of flight mass spectrometry and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 73 sitesin 2 countries
- Study dates
- Feb 2004to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-small cell lung cancer patients
Who may be able to join
- Patient must be ≥18 years of age.
- Patient must have a clinically suspicious stage I (cT1-2 N0 M0) lung lesion.
- 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.
- 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.
- 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.
- If patient is a survivor of a prior cancer, the following criteria are met:
Show all 9Show fewer
- Patient has undergone potentially curative therapy for all prior malignancies,
- 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),
- Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
Who cannot join
- Patient has undergone previous lung resection within the preceding 30 days.
- Patient has received prior chemotherapy or radiotherapy.
- Patient has had a blood product transfusion of any kind within the past 60 days of the operative procedure.
Trial locations and contacts
73 sites in 2 countries.
73 sites in 2 countries
United States72 sites
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307
Winship Cancer Institute of Emory University
Altanta, Georgia, 30322
AnMed Health Cancer Center
Anderson, South Carolina, 29621
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, 30912
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, 21204
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Cancer Treatment Center at Good Samaritan Hospital
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267
John Muir/Mount Diablo Cancer Center - Concord Campus
Concord, California, 94524-4110
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, 06810
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital
Dayton, Ohio, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, 45415
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
CCOP - Dayton
Dayton, Ohio, 45429
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, 91204
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, 54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429
Benedictine Hospital
Kingston, New York, 12401
U.T. Cancer Institute at University of Tennessee Medical Center
Knoxville, Tennessee, 37920-6999
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, 92357
Jewish Hospital
Louisville, Kentucky, 40202-1886
Middletown Regional Hospital
Middletown, Ohio, 45044
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, 26506
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, 16105
South Nassau Communities Hospital
Oceanside, New York, 11572
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224-1791
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, 02903
Miriam Hospital
Providence, Rhode Island, 02906
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, 47374
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Sutter Cancer Center at Roseville Medical Center
Roseville, California, 95661
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
Rutherford Hospital
Rutherfordton, North Carolina, 28139
Sutter Cancer Center
Sacramento, California, 95816
LDS Hospital
Salt Lake City, Utah, 84143
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98114
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Cancer Institute at St. John's Hospital
Springfield, Illinois, 62702
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9620
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
Stony Brook University Cancer Center
Stony Brook, New York, 11794-8174
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, 08629
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, 94598
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385
About this study
Official title: 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.
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.
- Conditions
- Lung Cancer
- Being tested
- proteomic profiling, surface-enhanced laser desorption/ionization-time of flight mass spectrometry, biopsy, surgery
- Keywords
- stage I non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proteomic profilingGenetic
surface-enhanced laser desorption/ionization-time of flight mass spectrometryOther
biopsyProcedure or surgery
surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: proteomic profiling; Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry; Procedure: biopsy; Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether the serum proteomic profile can predict the presence of primary lung cancer in patients with suspicious lung lesions
Measured: Up to 5 years
Survival
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2004 (estimated)
- Study startFeb 2004
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David H. Harpole, MD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077324
- Sponsor's protocol ID
- ACOSOG-Z4031
- Other IDs
- CDR0000350123
- Status last verified
- Jul 2016
- First submitted
- 10 Feb 2004
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
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 17240821Grogan 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00077324
- Acronym / sponsor ID
- ACOSOG-Z4031
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2004
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 12 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery + blood and serum collection | – | Genetic: proteomic profiling, Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry, Procedure: biopsy, Procedure: surgeryPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-small cell lung cancer patients
Key inclusion criteria (9 listed)
- Patient must be ≥18 years of age.
- Patient must have a clinically suspicious stage I (cT1-2 N0 M0) lung lesion.
- 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.
- 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.
- 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.
Key exclusion criteria (3 listed)
- Patient has undergone previous lung resection within the preceding 30 days.
- Patient has received prior chemotherapy or radiotherapy.
- Patient has had a blood product transfusion of any kind within the past 60 days of the operative procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proteomic profiling | Genetic | Surgery + blood and serum collection |
| surface-enhanced laser desorption/ionization-time of flight mass spectrometry | Other | Surgery + blood and serum collection |
| biopsy | Procedure or surgery | Surgery + blood and serum collection |
| surgery | Procedure or surgery | Surgery + blood and serum collection |
Primary outcome
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
Survival
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Background: PubMed 17240821Harpole DH, Meyerson SL. Lung cancer staging: proteomics. Thorac Surg Clin. 2006 Nov;16(4):339-43. doi: 10.1016/j.thorsurg.2006.10.001.
- Results publicationGrogan 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.
- Results publicationHarpole 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H. Harpole, MD study chair
Duke Cancer Institute
73 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology at 73 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00077324, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.