Spots Global Cancer Trial Database for Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32
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Trial Identification
Brief Title: Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32
Official Title: Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer
Study ID: NCT01286233
Study Description
Brief Summary: RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue. PURPOSE: This research study is studying biomarkers associated with fatigue in patients with early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.
Detailed Description: OBJECTIVES: * To prepare, separate into components, and store the blood specimens at the NSABP Serum Bank at Baylor College of Medicine Breast Center for future DNA, RNA, and plasma analysis, and to analyze specific proinflammatory cytokines, genetic polymorphisms, and RNA expression arrays in collaborating laboratories at University of California, Los Angeles (UCLA). * To examine the association between markers of inflammation and symptoms of fatigue among patients with and without exposure to metformin hydrochloride. * To examine the relationship between single nucleotide polymorphism (SNPs) in the promoter regions of IL-1 and IL-6 and symptoms of fatigue with and without exposure to metformin hydrochloride. * To examine RNA expression profiles in relationship to fatigue and compare the pattern of expression in patients with and without exposure to metformin hydrochloride. * To determine the biological and behavioral predictors of fatigue in breast cancer patients in the five years post-randomization. * To determine whether metformin is associated with reductions in inflammatory markers and corresponding decreases in fatigue. (Exploratory) OUTLINE: This is a multicenter study. Patients' serum and plasma, collected at baseline and at 6, 12, and 24 months after NCIC CTG MA.32 randomization, are analyzed for inflammatory markers, DNA polymorphisms, and RNA expression arrays by ELISA, TaqMan PCR, and RT-PCR. Patients complete the Fatigue Symptom Inventory (symptoms associated with fatigue, sleep disturbance, depression, and endocrine therapy) at baseline and periodically during study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Kaiser Permanente Medical Center - Anaheim/Orange County, Anaheim, California, United States
Kaiser Permanente - Deer Valley, Antioch, California, United States
Kaiser Permanente Medical Center - Baldwin Park, Baldwin Park, California, United States
Kaiser Permanente Medical Center - Bellflower, Bellflower, California, United States
Kaiser Permanente Medical Center - Fontana, Fontana, California, United States
Kaiser Permanente - Fremont, Fremont, California, United States
Kaiser Permanente Medical Center - Harbor City, Harbor City, California, United States
Kaiser Permanente Medical Center - Hayward, Hayward, California, United States
Kaiser Permanente - Irvine, Irvine, California, United States
Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, United States
Kaiser Foundation Hospital - West Los Angeles, Los Angeles, California, United States
Kaiser Permanente Medical Center - Oakland, Oakland, California, United States
Kaiser Permanente - Ontario Vineyard Medical Offices and Ambulatory SurgiCenter, Ontario, California, United States
Kaiser Permanente Medical Group, Panorama City, California, United States
Kaiser Permanente Medical Center - Redwood City, Redwood City, California, United States
Kaiser Permanente Medical Center - Richmond, Richmond, California, United States
Kaiser Permanente Medical Center - Riverside, Riverside, California, United States
Kaiser Permanente Medical Center - Roseville, Roseville, California, United States
South Sacramento Kaiser-Permanente Medical Center, Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento, Sacramento, California, United States
Kaiser Permanente Medical Office -Vandever Medical Office, San Diego, California, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego, San Diego, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus, San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Teresa, San Jose, California, United States
Kaiser Permanente Health Care, San Marcos, California, United States
Kaiser Foundation Hospital - San Rafael, San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus, Santa Clara, California, United States
Kaiser Permanente Medical Center - Santa Rosa, Santa Rosa, California, United States
Kaiser Permanente Medical Center - South San Francisco, South San Francisco, California, United States
Kaiser Permanente Medical Facility - Stockton, Stockton, California, United States
Kaiser Permanente Medical Center - Vacaville, Vacaville, California, United States
Kaiser Permanente Medical Center - Vallejo, Vallejo, California, United States
Kaiser Permanente Medical Center - Walnut Creek, Walnut Creek, California, United States
Kaiser Permanente Medical Cener - Woodland Hills, Woodland Hills, California, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Front Range Cancer Specialists, Fort Collins, Colorado, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital, Albany, Georgia, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Kaiser Permanente - Moanalua Medical Center and Clinic, Honolulu, Hawaii, United States
St. Joseph Regional Medical Center, Lewiston, Idaho, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Illinois CancerCare - Bloomington, Bloomington%, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Illinois CancerCare - Canton, Canton, Illinois, United States
Illinois CancerCare - Carthage, Carthage, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Resurrection Medical Center, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Illinois CancerCare - Eureka, Eureka, Illinois, United States
Evanston Hospital, Evanston, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Illinois CancerCare - Galesburg, Galesburg, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, United States
Illinois CancerCare - Havana, Havana, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare - Macomb, Macomb, Illinois, United States
McDonough District Hospital, Macomb, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States
, Moline, Illinois, United States
Illinois CancerCare - Monmouth, Monmouth, Illinois, United States
OSF Holy Family Medical Center, Monmouth, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Illinois CancerCare - Pekin, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare - Peru, Peru, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Illinois CancerCare - Princeton, Princeton, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Illinois CancerCare - Spring Valley, Spring Valley, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Central Dupage Cancer Center, Warrenville, Illinois, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte, Westville, Indiana, United States
, Bettendorf, Iowa, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal, Liberal, Kansas, United States
Cancer Center of Kansas, PA - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Central Baptist Hospital, Lexington, Kentucky, United States
York Hospital's Oncology Treatment Center, York, Maine, United States
Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick, Maryland, United States
Addison Gilbert Hospital, Gloucester, Massachusetts, United States
Lowell General Hospital, Lowell, Massachusetts, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States
Mecosta County Medical Center, Big Rapids, Michigan, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
Dickinson County Healthcare System, Iron Mountain, Michigan, United States
Mercy General Health Partners, Muskegon, Michigan, United States
Spectrum Health Reed City Hospital, Reed City, Michigan, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
St. Joseph's Medical Center, Brainerd, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller - Dwan Medical Center, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Minnesota Oncology - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
CentraCare Clinic - River Campus, Saint Cloud, Minnesota, United States
Coborn Cancer Center, Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States
Regions Hospital Cancer Care Center, St. Paul, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology - Woodbury, Woodbury, Minnesota, United States
Saint Luke's Hospital, Chesterfield, Missouri, United States
Midwest Hematology Oncology Group, Incorporated, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States
Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney, Nebraska, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
Immanuel Medical Center, Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska, United States
Lakeside Hospital, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care, Concord, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Lakes Region General Hospital, Laconia, New Hampshire, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States
Monter Cancer Center of the North Shore-LIJ Health System, Lake Success, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
CaroMont Cancer Center at Gaston Memorial Hospital, Gastonia, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Pardee Memorial Hospital, Hendersonville, North Carolina, United States
High Point Regional Hospital, High Point, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst, North Carolina, United States
Rex Cancer Center at Rex Hospital, Raleigh, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Dakota Cancer Institute at Dakota Clinic - South University, Fargo, North Dakota, United States
Trinity CancerCare Center, Minot, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Aultman Cancer Center at Aultman Hospital, Canton, Ohio, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Providence Newberg Medical Center, Newberg, Oregon, United States
Willamette Falls Hospital, Oregon City, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Kaiser Permanente Health Care - Portland, Portland, Oregon, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
Cancer Center at Phoenixville Hospital, Phoenixville, Pennsylvania, United States
UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States
Chester County Hospital, West Chester, Pennsylvania, United States
CCOP - Main Line Health, Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
AnMed Cancer Center, Anderson, South Carolina, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Doctor's Hospital of Laredo, Laredo, Texas, United States
Mountainview Medical, Berlin, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Overlake Cancer Center at Overlake Hospital Medical Center, Bellevue, Washington, United States
Providence Centralia Hospital, Centralia, Washington, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
St. Francis Hospital, Federal Way, Washington, United States
Providence St. Peter Hospital Regional Cancer Center, Olympia, Washington, United States
Good Samaritan Cancer Center, Puyallup, Washington, United States
Franciscan Cancer Center at St. Joseph Medical Center, Tacoma, Washington, United States
Allenmore Hospital, Tacoma, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma, Washington, United States
St. Clare Hospital, Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin, United States
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
St. Catharines General Hospital at Niagara Health System, Saint Catharines, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Norman Wolmark, MD
Affiliation: NSABP Foundation Inc
Role: PRINCIPAL_INVESTIGATOR
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