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RecruitingObservational

Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study

NCT ID: NCT03998202Sponsor: Wake Forest University Health SciencesLast updated: 2026-01-08

Summary

This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.

Detailed description

This is a prospective cohort study that examines the impact of myopenia on chemotherapy toxicity in overall survival (OS) in older adults with newly diagnosed metastatic colorectal cancer (CRC) receiving 5-Fluouracil (5FU)systemic chemotherapy. The study also explores the mediating influence of genetic variation in the association between myopenia and chemotherapy toxicity.

Arms & interventions

Outcome measures

Primary

  • Number of Chemotherapy Toxicities (Grade 3 - 5)

    Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).

    Time frame: Up to 6 months (after initiation of chemotherapy)

Secondary

  • Overall Survival

    Time frame: 1 year

Eligibility criteria

Sex: AllAge: 60 Years and olderHealthy volunteers: No
Inclusion Criteria: * Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC \>= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC. * Planning to or recently started to undergo undergo immunotherapy and/or 5-FU based chemotherapy as a first line of treatment. 5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. Capecitabine is also acceptable. * Estimated life expectancy \>= 6 months. * Patients must be able to comprehend English or Spanish (for questionnaire completion). * Ability to understand and the willingness to sign a written informed consent document. * Patient eligibility is not dependent on BMI or weight. Patients with a significant (+- \> 10%) body weight change in the previous 12 months are eligible for this study. Exclusion Criteria: * Patients enrolled on hospice. * Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed \>= 3 months (12 weeks) prior to this disease disease recurrence and treatment). * Patients may not be receiving any other investigational agents. * No untreated brain metastases. Patients with treated brain metastases are eligible. * Patients on or planned to undergo radiation therapy in near future.

Study locations (146)

Beebe South Coastal Health Campus

Millville, Delaware, 19967

Recruiting
Site Public Contact · Contact
Gregory A. Masters · Principal Investigator

Helen F Graham Cancer Center

Newark, Delaware, 19713

Recruiting
Site Public Contact · Contact
Gregory A. Masters · Principal Investigator

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

Recruiting
Site Public Contact · Contact
Gregory A. Masters · Principal Investigator

Beebe Health Campus

Rehoboth Beach, Delaware, 19971

Recruiting
Site Public Contact · Contact
Gregory A. Masters · Principal Investigator

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801

Recruiting
Gregory Masters · Principal Investigator

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007

Recruiting
Site Public Contact · Contact
Marcus S. Noel · Principal Investigator

John B Amos Cancer Center

Columbus, Georgia, 31904

Recruiting
Andrew Pippas · Principal Investigator

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Illinois CancerCare-Canton

Canton, Illinois, 61520

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

SIH Cancer Institute

Carterville, Illinois, 62918

Recruiting
Brian Faller · Principal Investigator

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612

Recruiting
Site Public Contact · Contact
Thomas E. Lad · Principal Investigator

Carle at The Riverfront

Danville, Illinois, 61832

Recruiting
Suparna Mantha · Principal Investigator

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Crossroads Cancer Center

Effingham, Illinois, 62401

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

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Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Carle Physician Group - Mattoon/Charleston

Mattoon, Illinois, 61938

Recruiting
Suparna Mantha · Principal Investigator

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864

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Site Public Contact · Contact
Jay W. Carlson · Principal Investigator

Carle BroMenn Medical Center

Normal, Illinois, 61761

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Suparna Mantha · Principal Investigator

Carle Cancer Institute Normal

Normal, Illinois, 61761

Recruiting
Suparna Mantha · Principal Investigator

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

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Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

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Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

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Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Illinois CancerCare-Peru

Peru, Illinois, 61354

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Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

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Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Springfield Clinic

Springfield, Illinois, 62702

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Carle Cancer Center

Urbana, Illinois, 61801

Recruiting
Site Public Contact · Contact
Suparna Mantha · Principal Investigator

Illinois CancerCare - Washington

Washington, Illinois, 61571

Recruiting
Bryan Faller · Principal Investigator

The University of Iowa - Ankeny

Ankeny, Iowa, 50023

Recruiting
· Contact
Richard Deming · Principal Investigator

Saint Anthony Regional Hospital

Carroll, Iowa, 51401

Recruiting
Seema Harichand-Herdt · Principal Investigator

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, 52402

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· Contact
Bhaarat Jenigiri · Principal Investigator

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403

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Site Public Contact · Contact
Deborah W. Wilbur · Principal Investigator

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325

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· Contact
Seema Harichand-Herdt · Principal Investigator

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

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· Contact
Seema Harichand-Herdt · Principal Investigator

The University of Iowa-Des Moines

Des Moines, Iowa, 50309

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Site Public Contact · Contact
Seema Harichand-Herdt · Principal Investigator

Broadlawns Medical Center

Des Moines, Iowa, 50314

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· Contact
Seema Harichand-Herdt · Principal Investigator

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

Recruiting
Richard L Deming · Principal Investigator

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314

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· Contact
Seema Harichand-Herdt · Principal Investigator

UI Healthcare Mission Cancer and Blood - Fort Dodge

Fort Dodge, Iowa, 50501

Recruiting
Seema Harichand-Herdt · Principal Investigator

Saint Joseph Hospital East

Lexington, Kentucky, 40509

Withdrawn

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, 70809

Recruiting
Victor Lin · Principal Investigator

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809

Recruiting
Victor Lin · Principal Investigator

MBP Cancer Center - Baton Rouge General

Baton Rouge, Louisiana, 70809

Recruiting
Victor Lin · Principal Investigator

Terrebonne General Medical Center

Houma, Louisiana, 70360

Recruiting
Victor Lin · Principal Investigator

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

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Tareq Al baghadadi · Principal Investigator

Trinity Health IHA Medical Group Hematology Oncology-Brighton

Brighton, Michigan, 48114

Recruiting
Tareq Al baghadadi · Principal Investigator

Trinity Health Medical Center-Brighton

Brighton, Michigan, 48114

Recruiting
Tareq Al baghadadi · Principal Investigator

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

Recruiting
Tareq Al baghadadi · Principal Investigator

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

Recruiting
Tareq Al baghadadi · Principal Investigator

Chelsea Hospital

Chelsea, Michigan, 48118

Recruiting
Tareq Al baghadadi · Principal Investigator

Trinity Health IHA Hematology Oncology Consultants-Chelsea Hospital

Chelsea, Michigan, 48118

Recruiting
Tareq Al baghadadi · Principal Investigator

Cancer Hematology Centers - Flint

Flint, Michigan, 48503

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Site Public Contact · Contact
Tareq Al baghadadi · Principal Investigator

Genesee Hematology Oncology PC

Flint, Michigan, 48503

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Site Public Contact · Contact
Tareq Al baghadadi · Principal Investigator

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

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Site Public Contact · Contact
Tareq Al baghadadi · Principal Investigator

Marshfield Medical Center Dickinson

Iron Mountain, Michigan, 49801

Recruiting
Laura Lauer · Principal Investigator

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

Recruiting
Tareq Al baghadadi · Principal Investigator

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

Recruiting
Tareq Al baghadadi · Principal Investigator

Corewell Health Reed City Hospital

Reed City, Michigan, 49677

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Site Public Contact · Contact
Kathleen J. Yost · Principal Investigator

University of Michigan Health - West

Wyoming, Michigan, 49519

Recruiting
Site Public Contact · Contact
Kathleen J. Yost · Principal Investigator

Trinity Health IHA Medical Group Hematology Oncology -Ann Arbor

Ypsilanti, Michigan, 48197

Recruiting
Tareq Al baghadadi · Principal Investigator

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

Recruiting
Daniel Almquist · Principal Investigator

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401

Recruiting
Bret Friday · Principal Investigator

Mercy Hospital

Coon Rapids, Minnesota, 55433

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Site Public Contact · Contact
Lisa Lafranchi · Principal Investigator

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636

Recruiting
Bret Friday · Principal Investigator

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501

Recruiting
Bret Friday · Principal Investigator

Essentia Health Cancer Center

Duluth, Minnesota, 55805

Recruiting
Bret Friday · Principal Investigator

Fairview Southdale Hospital

Edina, Minnesota, 55435

Recruiting
Site Public Contact · Contact
Lisa Lafranchi · Principal Investigator

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746

Recruiting
· Contact
Bret Friday · Principal Investigator

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109

Recruiting
Lisa Lafranchi · Principal Investigator

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109

Recruiting
Site Public Contact · Contact
Lisa Lafranchi · Principal Investigator

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

Recruiting
Lisa Lafranchi · Principal Investigator

Health Partners Inc

Minneapolis, Minnesota, 55454

Withdrawn

New Ulm Medical Center

New Ulm, Minnesota, 56073

Recruiting
Site Public Contact · Contact
Lisa Lafranchi · Principal Investigator

Essentia Health - Park Rapids

Park Rapids, Minnesota, 56470

Recruiting
Bret Friday · Principal Investigator

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

Recruiting
Site Public Contact · Contact
Lisa Lafranchi · Principal Investigator

Regions Hospital

Saint Paul, Minnesota, 55101

Recruiting
Site Public Contact · Contact
Lisa Lafranchi · Principal Investigator

United Hospital

Saint Paul, Minnesota, 55102

Recruiting
Site Public Contact · Contact
Lisa Lafranchi · Principal Investigator

Essentia Health Sandstone

Sandstone, Minnesota, 55072

Recruiting
Bret Friday · Principal Investigator

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379

Recruiting
Site Public Contact · Contact
Lisa Lafranchi · Principal Investigator

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792

Recruiting
Bret Friday · Principal Investigator

Rice Memorial Hospital

Willmar, Minnesota, 56201

Recruiting
Site Public Contact · Contact
Lisa Lafranchi · Principal Investigator

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Parkland Health Center - Farmington

Farmington, Missouri, 63640

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401

Withdrawn

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506

Recruiting
Jay Carlson · Principal Investigator

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Mercy Hospital Springfield

Springfield, Missouri, 65804

Recruiting
Site Public Contact · Contact
Jay W. Carlson · Principal Investigator

CoxHealth South Hospital

Springfield, Missouri, 65807

Recruiting
· Contact
Jay Carlson · Principal Investigator

Missouri Baptist Medical Center

St Louis, Missouri, 63131

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

Recruiting
· Contact
Kunal Kadakia · Principal Investigator

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, 28210

Recruiting
· Contact
Kunal Kadakia · Principal Investigator

Levine Cancer Institute-SouthPark

Charlotte, North Carolina, 28211

Recruiting
· Contact
Kunal Kadakia · Principal Investigator

Atrium Health University City/LCI-University

Charlotte, North Carolina, 28262

Recruiting
· Contact
Kunal Kadakia · Principal Investigator

Wake Forest University at Clemmons

Clemmons, North Carolina, 27012

Recruiting
Site Public Contact · Contact
Glenn J. Lesser · Principal Investigator

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025

Recruiting
· Contact
Kunal Kadakia · Principal Investigator

Levine Cancer Institute-Gaston

Gastonia, North Carolina, 28054

Recruiting
· Contact
Kunal Kadakia · Principal Investigator

Wake Forest Baptist Health - Wilkes Medical Center

Wilkesboro, North Carolina, 28659

Recruiting
· Contact
Glenn J Lesser · Principal Investigator

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Recruiting
Site Public Contact · Contact
Glenn J. Lesser · Principal Investigator

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

Recruiting
Daniel Almquist · Principal Investigator

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103

Recruiting
Bret Friday · Principal Investigator

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

Recruiting
Daniel Almquist · Principal Investigator

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

Recruiting
Daniel Almquist · Principal Investigator

Adena Regional Medical Center

Chillicothe, Ohio, 45601

Recruiting
Site Public Contact · Contact
William Wilson · Principal Investigator

The Mark H Zangmeister Center

Columbus, Ohio, 43219

Recruiting
Site Public Contact · Contact
William Wilson · Principal Investigator

Armes Family Cancer Center

Findlay, Ohio, 45840

Recruiting
Site Public Contact · Contact
Howard M. Gross · Principal Investigator

Knox Community Hospital

Mount Vernon, Ohio, 43050

Recruiting
Wilson William · Principal Investigator

Licking Memorial Hospital

Newark, Ohio, 43055

Recruiting
William Wilson · Principal Investigator

Southern Ohio Medical Center

Portsmouth, Ohio, 45662

Recruiting
Site Public Contact · Contact
William Wilson · Principal Investigator

Springfield Regional Cancer Center

Springfield, Ohio, 45504

Recruiting
William Wilson · Principal Investigator

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701

Recruiting
William Wilson · Principal Investigator

Geisinger Medical Center

Danville, Pennsylvania, 17822

Recruiting
Site Public Contact · Contact
Sorab Gupta · Principal Investigator

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, 18201

Recruiting
Site Public Contact · Contact
Sorab Gupta · Principal Investigator

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837

Recruiting
Site Public Contact · Contact
Sorab Gupta · Principal Investigator

Lewistown Hospital

Lewistown, Pennsylvania, 17044

Recruiting
Site Public Contact · Contact
Sorab Gupta · Principal Investigator

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, 17901

Recruiting
Site Public Contact · Contact
Sorab Gupta · Principal Investigator

Community Medical Center

Scranton, Pennsylvania, 18510

Recruiting
Site Public Contact · Contact
Sorab Gupta · Principal Investigator

Geisinger Medical Oncology-Selinsgrove

Selinsgrove, Pennsylvania, 17870

Recruiting
Site Public Contact · Contact
Sorab Gupta · Principal Investigator

Geisinger Medical Group

State College, Pennsylvania, 16801

Recruiting
Site Public Contact · Contact
Sorab Gupta · Principal Investigator

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711

Recruiting
Site Public Contact · Contact
Sorab Gupta · Principal Investigator

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316

Recruiting
Site Public Contact · Contact
Ki Young K. Chung · Principal Investigator

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640

Recruiting
Site Public Contact · Contact
Ki Young K. Chung · Principal Investigator

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, 29341

Recruiting
Site Public Contact · Contact
James D. Bearden · Principal Investigator

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605

Recruiting
Site Public Contact · Contact
Ki Young K. Chung · Principal Investigator

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605

Recruiting
Site Public Contact · Contact
Ki Young K. Chung · Principal Investigator

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615

Recruiting
Site Public Contact · Contact
Ki Young K. Chung · Principal Investigator

Self Regional Healthcare

Greenwood, South Carolina, 29646

Withdrawn

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650

Recruiting
Site Public Contact · Contact
Ki Young K. Chung · Principal Investigator

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651

Recruiting
Site Public Contact · Contact
James D. Bearden · Principal Investigator

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672

Recruiting
Site Public Contact · Contact
Ki Young K. Chung · Principal Investigator

Spartanburg Medical Center

Spartanburg, South Carolina, 29303

Recruiting
Site Public Contact · Contact
James D. Bearden · Principal Investigator

MGC Hematology Oncology-Union

Union, South Carolina, 29379

Recruiting
Site Public Contact · Contact
James D. Bearden · Principal Investigator

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

Recruiting
Daniel Almquist · Principal Investigator

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

Recruiting
Daniel Almquist · Principal Investigator

Duluth Clinic Ashland

Ashland, Wisconsin, 54806

Recruiting
Bret Friday · Principal Investigator

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

Recruiting
Laura Lauer · Principal Investigator

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

Recruiting
Site Public Contact · Contact
Anthony J. Jaslowski · Principal Investigator

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303

Recruiting
Site Public Contact · Contact
Anthony J. Jaslowski · Principal Investigator

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

Recruiting
Laura Lauer · Principal Investigator

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

Recruiting
Laura Lauer · Principal Investigator

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

Recruiting
Laura Lauer · Principal Investigator

Essentia Health-Spooner Clinic

Spooner, Wisconsin, 54801

Recruiting
Bret EB Friday · Principal Investigator

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

Recruiting
Laura Lauer · Principal Investigator

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

Recruiting
Anthony Jaslowski · Principal Investigator

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

Recruiting
Laura Lauer · Principal Investigator