AzTrials
AzTrials

Lung CancerNCT00450281

S0424 - Carcinogens in Lung Tissue From Smokers (Closed to Entry as of 7/15/07) and Non-Smokers With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

An observational study of Lung Cancer, run by SWOG Cancer Research Network at 405 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07) and non-smokers with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
chromogenic in situ hybridization, gene expression analysis and mutation analysis
Type of treatment
Surgery or procedure
How many people
981 participants
Where
405 sitesUnited States
Study dates
Oct 2005to Jul 2012
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Cancer center

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer
  • Stage I, II, IIIA, or IIIB (T4 or N3) disease
  • No malignant pleural effusion; if pleural fluid is present, 1 of the following criteria must be met:
  • Benign pleural fluid
  • Pleural fluid is due to prior thoracotomy
  • Pleural fluid is deemed too small to safely tap
  • No diagnosis by cytology alone
  • Newly diagnosed disease
  • Must have tumor blocks/slides available and must be willing to provide tissue samples
  • Prior smoking history meeting 1 of the following criteria:
  • Never smoker, defined as < 100 cigarettes in lifetime
  • Former smoker, defined as no smoking for ≥ 1 year
  • Current smoker, defined as all others (closed to accrual as of 7/15/07)
  • No pericardial effusions

PATIENT CHARACTERISTICS:

  • No other prior malignancy except for 1 of the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • In situ cervical cancer
  • Other cancer for which the patient has been disease free for five years

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
  • Concurrent participation in therapeutic trials allowed

Trial locations and contacts

405 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • American Fork Hospital

    American Fork, Utah, 84003

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Kaiser Permanente - Deer Valley

    Antioch, California, 94531

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Cancer Resource Center at King's Daughters Medical Center

    Ashland, Kentucky, 41101-0151

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts, 02703

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Bloomington Hospital Regional Cancer Institute

    Bloomington, Indiana, 47403

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Caritas St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135-2997

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Martha Jefferson Hospital Cancer Care Center

    Charlottesville, Virginia, 22901

  • H. Clay Evans Johnson Cancer Center at Memorial Hospital

    Chattanooga, Tennessee, 37404

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic - Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Good Samaritan Hospital Cancer Treatment Center

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • North Coast Cancer Care - Clyde

    Clyde, Ohio, 43410

  • Memorial Hospital Cancer Center - Colorado Springs

    Colorado Springs, Colorado, 80909

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Kaiser Permanente - Denver

    Denver, Colorado, 80205

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • St. Luke's Hospital Cancer Care Center

    Duluth, Minnesota, 55805

  • Cancer Centers of the Carolinas - Easley

    Easley, South Carolina, 29640

  • Center for Cancer Treatment & Prevention at Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • North Bay Cancer Center

    Fairfield, California, 94533

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • CaroMont Cancer Center at Gaston Memorial Hospital

    Gastonia, North Carolina, 28053

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    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

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas - Grove Commons

    Greenville, South Carolina, 29605

  • Greenville Hospital Cancer Center

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas - Eastside

    Greenville, South Carolina, 29615

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Self Regional Cancer Center at Self Regional Medical Center

    Greenwood, South Carolina, 29646

  • Cancer Centers of the Carolinas - Greer Medical Oncology

    Greer, South Carolina, 29650

  • Cancer Centers of the Carolinas - Greer Radiation Oncology

    Greer, South Carolina, 29650

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Hays Medical Center

    Hays, Kansas, 67601

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • High Point Regional Hospital

    High Point, North Carolina, 27261

  • Kaiser Permanente - Moanalua Medical Center and Clinic

    Honolulu, Hawaii, 96819

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Hutchinson Hospital Corporation

    Hutchinson, Kansas, 65702

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology Oncology Associates, Incorporated

    Kansas City, Missouri, 64118

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • U.T. Medical Center Cancer Institute

    Knoxville, Tennessee, 37920-6999

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Kaiser Permanente - Lafayette

    Lafayette, Colorado, 80026

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67905

  • Liberty Hospital

    Liberty, Missouri, 64068

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Jewish Hospital

    Louisville, Kentucky, 40202-1886

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Don Monti Comprehensive Cancer Center at North Shore University Hospital

    Manhasset, New York, 11030

  • Holy Family Memorial Medical Center Cancer Care Center

    Manitowoc, Wisconsin, 54221-1450

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP

    Marysville, California, 95901

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Caritas Holy Family Hospital

    Methuen, Massachusetts, 01844

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Trinity CancerCare Center

    Minot, North Dakota, 58701

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Louisiana State University Health Sciences Center - Monroe

    Monroe, Louisiana, 71210

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Clemens Regional Medical Center

    Mount Clemens, Michigan, 48043

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60540

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Beth Israel Medical Center - Petrie Division

    New York, New York, 10003-3803

  • St. Luke's - Roosevelt Hospital Center - St.Luke's Division

    New York, New York, 10025

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Fisher-Titus Medical Center

    Norwalk, Ohio, 44857

  • Caritas Norwood Hospital

    Norwood, Massachusetts, 02062

  • Kaiser Permanente Medical Center - Oakland

    Oakland, California, 94611

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Willamette Falls Hospital

    Oregon City, Oregon, 97045

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • McCreery Cancer Center at Ottumwa Regional

    Ottumwa, Iowa, 52501

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's Hospital - South

    Overland Park, Kansas, 66213

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Mount Carmel Regional Cancer Center

    Pittsburg, Kansas, 66762

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Adventist Medical Center

    Portland, Oregon, 97216

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Harrison Poulsbo Hematology and Onocology

    Poulsbo, Washington, 98370

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • All Saints Cancer Center at Wheaton Franciscan Healthcare

    Racine, Wisconsin, 53405

  • Kaiser Permanente Medical Center - Redwood City

    Redwood City, California, 94063

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Kaiser Permanente Medical Center - Richmond

    Richmond, California, 94801

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274-2600

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York, 14621

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Harbin Clinic Cancer Center - Medical Oncology

    Rome, Georgia, 30165

  • Kaiser Permanente Medical Center - Roseville

    Roseville, California, 95661

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Mercy General Hospital

    Sacramento, California, 95819

  • Kaiser Permanente Medical Center - Sacramento

    Sacramento, California, 95825

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology, Incorporated

    Saint Joseph, Missouri, 64507

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • LDS Hospital

    Salt Lake City, Utah, 84103

Other trials in United States

About this study

Official title: Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men

RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07) and non-smokers with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about risk factors for lung cancer and may help the study of cancer in the future.

PURPOSE: This clinical trial is studying carcinogens in lung tissue from smokers (closed to entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Assess lung tissue from patients with stage I, stage II, stage IIIA, or stage IIIB non-small cell lung cancer for specific tobacco smoke carcinogens (including polycyclic aromatic hydrocarbons [PAH] and DNA adducts, alterations in specific genes, including p53 and K-ras, and expression of HER2 and estrogen receptors α and β).
  • Determine whether tobacco smoke carcinogens differ by gender and smoking status, adjusting for potential exposures and influential factors, including family smoking status, medication use, and hormonal and reproductive factors.
  • Measure the levels of PAH-DNA adducts in lymphocytes and lung tissue and examine correlations between the two tissue sources.
  • Determine whether DNA damage levels in tissue as well as in lymphocytes are higher in females than in males for the same level of smoking.
  • Determine polymorphisms in several genes involved in the metabolism of the specific carcinogens investigated and in steroidogenesis and metabolism.
  • Summarize patient self-report questionnaire data on active and passive smoking, other carcinogenic exposures, smoking preference, economic and educational status, family smoking status, reproductive factors, weight loss, and medication use by categories of male versus female and never-smoker versus ever-smoker.

OUTLINE: This is a case-series, multicenter study. Patients are stratified according to gender and smoking status (never smoker [< 100 cigarettes smoked during lifetime] vs ever smoker [≥ 100 cigarettes smoked during lifetime] [closed to accrual as of 7/15/07]).

Patients complete the Lung Cancer Epidemiology Questionnaire for detailed assessment of the following:

  • Exposure to active and passive smoke
  • Occupational exposures
  • Reproductive and hormonal risk factors
  • Weight loss
  • Economic and educational status
  • Family smoking status
  • Medication use
  • Other variables relevant for the analysis (e.g., HER2, estrogen receptor status) Peripheral blood samples are collected for research studies. Previously collected tissue samples are also studied in the laboratory. Samples are examined for DNA adduct levels. Estrogen receptor α and β are assessed by immunohistochemistry (IHC). HER2 expression and amplification are measured by chromogenic in situ hybridization. IHC and DNA-polymerase chain reaction (PCR)-single-stranded conformational polymorphism assay are used to analyze p53 mutations. RAS mutations are analyzed with restriction fragment length polymorphism-PCR assay. Polycyclic aromatic hydrocarbons and 4-aminobiphenyl-DNA damage are assessed by IHC and immunofluorescence. Matrix-assisted laser desorption/ionization time of flight mass spectrometry is used to genotype polymorphisms, including CYP1A1, CYP1B1, GSTM1, GSTP1, MPO, NAT-1, NAT-2, CYP19, CYP17, SULT1A1.

Patients are followed annually for up to 5 years.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study (female and male smoker strata closed to accrual as of 7/15/07).

Conditions
Lung Cancer
Being tested
chromogenic in situ hybridization, gene expression analysis, mutation analysis, polymerase chain reaction, polymorphism analysis
Keywords
stage IIIB non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB 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.

  • chromogenic in situ hybridizationGenetic

  • gene expression analysisGenetic

  • mutation analysisGenetic

  • polymerase chain reactionGenetic

  • polymorphism analysisGenetic

  • fluorescent antibody techniqueOther

  • immunohistochemistry staining methodOther

  • laboratory biomarker analysisOther

  • matrix-assisted laser desorption/ionization time of flight mass spectrometryOther

  • study of socioeconomic and demographic variablesOther

  • study of high risk factorsProcedure or surgery

Study groups in NCT00450281
Study groupRoleWhat they receive
Male, Never-smokersMale subjects who smoked less than 100 cigarettes during their lifetime.
Receives: Genetic: chromogenic in situ hybridization; Genetic: gene expression analysis; Genetic: mutation analysis; Genetic: polymerase chain reaction; Genetic: polymorphism analysis; Other: fluorescent antibody technique; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry; Other: study of socioeconomic and demographic variables; Procedure: study of high risk factors
Male, Ever-smokersMale subjects who have smoked at least 100 cigarettes during their lifetime.
Receives: Genetic: chromogenic in situ hybridization; Genetic: gene expression analysis; Genetic: mutation analysis; Genetic: polymerase chain reaction; Genetic: polymorphism analysis; Other: fluorescent antibody technique; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry; Other: study of socioeconomic and demographic variables; Procedure: study of high risk factors
Female, Ever-smokersFemale subjects who have smoked less than 100 cigarettes during their lifetime.
Receives: Genetic: chromogenic in situ hybridization; Genetic: gene expression analysis; Genetic: mutation analysis; Genetic: polymerase chain reaction; Genetic: polymorphism analysis; Other: fluorescent antibody technique; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry; Other: study of socioeconomic and demographic variables; Procedure: study of high risk factors
Female, Never-smokersFemale subjects who have smoked at least 100 cigarettes during their lifetime.
Receives: Genetic: chromogenic in situ hybridization; Genetic: gene expression analysis; Genetic: mutation analysis; Genetic: polymerase chain reaction; Genetic: polymorphism analysis; Other: fluorescent antibody technique; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry; Other: study of socioeconomic and demographic variables; Procedure: study of high risk factors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DNA adduct levels

    Measured: End of study

  2. Tumor tissue alterations

    Measured: End of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2007 (estimated)
  2. Study startOct 2005
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

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
981 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00450281
Sponsor's protocol ID
CDR0000446084
Other IDs
S0424, U10CA032102
Status last verified
Dec 2013
First submitted
20 Mar 2007
Last updated
26 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by SWOG Cancer Research Network at 405 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 405 sites in United States. 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?

DNA adduct levels (time frame: End of study). 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 NCT00450281.

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 26 Oct 2015.

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