LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia | NCT06073431 | Trialant

LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia | NCT06073431 | Trialant

Official Title: Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia
Brief Summary: This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.
Detailed Description: PRIMARY OBJECTIVE:

I. To identify multiple distinct diagnostic subtypes within the syndrome of CC as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC.

SECONDARY OBJECTIVES:

I. To determine the association of each CC phenotype with overall survival. II. To validate CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by our collaborators at Kaiser Permanente.

III. To collect human samples of blood, tumor tissue, and medical images and build a large, comprehensive CC database clinically annotated with cancer-related outcomes, cachexia symptoms, and physical function data.

EXPLORATORY OBJECTIVE:

I. To evaluate for tumor-derived factors contributing to CC by determining the association between interleukin-6 (IL-6) expression in tumor and IL-6 and CC chemokine ligand 2 (CCL2) levels in the blood in patients with CC.

OUTLINE: This is an observational study.

Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care computed tomography (CT) or positron emission tomography (PET)/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.

Mercy Hospital Fort SmithRecruiting

Fort Smith, Arkansas 72903, United States

Site Public ContactContact

800-378-9373

Jay W. CarlsonPrincipal Investigator

Rocky Mountain Cancer Centers-AuroraActive, not recruiting

Aurora, Colorado 80012, United States

Boulder Community Foothills HospitalActive, not recruiting

Boulder, Colorado 80303, United States

Rocky Mountain Cancer Centers-BoulderActive, not recruiting

Boulder, Colorado 80304, United States

Rocky Mountain Cancer Centers - CentennialActive, not recruiting

Centennial, Colorado 80112, United States

The Women's Imaging CenterActive, not recruiting

Denver, Colorado 80209, United States

Colorado Blood Cancer InstituteActive, not recruiting

Denver, Colorado 80218, United States

Rocky Mountain Cancer Centers-MidtownActive, not recruiting

Denver, Colorado 80218, United States

Rocky Mountain Cancer Centers-RoseActive, not recruiting

Denver, Colorado 80220, United States

Rocky Mountain Cancer Centers - SwedishActive, not recruiting

Englewood, Colorado 80113, United States

The Melanoma and Skin Cancer InstituteActive, not recruiting

Englewood, Colorado 80113, United States

Rocky Mountain Cancer Centers-LakewoodActive, not recruiting

Lakewood, Colorado 80228, United States

Rocky Mountain Cancer Centers-LittletonActive, not recruiting

Littleton, Colorado 80120, United States

Rocky Mountain Cancer Centers-Sky RidgeActive, not recruiting

Lone Tree, Colorado 80124, United States

Rocky Mountain Cancer Centers-ThorntonActive, not recruiting

Thornton, Colorado 80260, United States

Beebe South Coastal Health CampusRecruiting

Millville, Delaware 19967, United States

Helen F Graham Cancer CenterRecruiting

Newark, Delaware 19713, United States

Medical Oncology Hematology Consultants PARecruiting

Newark, Delaware 19713, United States

Christiana Care Health System-Christiana HospitalRecruiting

Newark, Delaware 19718, United States

Beebe Health CampusRecruiting

Rehoboth Beach, Delaware 19971, United States

Christiana Care Health System-Wilmington HospitalRecruiting

Wilmington, Delaware 19801, United States

MedStar Georgetown University HospitalRecruiting

Washington D.C., District of Columbia 20007, United States

Northside HospitalRecruiting

Atlanta, Georgia 30342, United States

Northeast Georgia Medical Center BraseltonRecruiting

Braselton, Georgia 30517, United States

John B Amos Cancer CenterRecruiting

Columbus, Georgia 31904, United States

Northside Hospital - DuluthRecruiting

Duluth, Georgia 30096, United States

Northeast Georgia Medical Center-GainesvilleRecruiting

Gainesville, Georgia 30501, United States

The Longstreet Clinic - GainesvilleRecruiting

Gainesville, Georgia 30501, United States

Northside Hospital - GwinnettRecruiting

Lawrenceville, Georgia 30046, United States

Memorial Health University Medical CenterRecruiting

Savannah, Georgia 31404, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting

Savannah, Georgia 31405, United States

Tift Regional Medical CenterRecruiting

Tifton, Georgia 31794, United States

South Georgia Medical Center/Pearlman Cancer CenterRecruiting

Valdosta, Georgia 31602, United States

Hawaii Cancer Care Inc - Waterfront PlazaRecruiting

Honolulu, Hawaii 96813, United States

Queen's Cancer Cenrer - POB IRecruiting

Honolulu, Hawaii 96813, United States

Queen's Medical CenterRecruiting

Honolulu, Hawaii 96813, United States

Straub Clinic and HospitalRecruiting

Honolulu, Hawaii 96813, United States

Queen's Cancer Center - KuakiniRecruiting

Honolulu, Hawaii 96817, United States

Kapiolani Medical Center for Women and ChildrenRecruiting

Honolulu, Hawaii 96826, United States

Hawaii Cancer Care - WestridgeRecruiting

‘Aiea, Hawaii 96701, United States

Pali Momi Medical CenterRecruiting

‘Aiea, Hawaii 96701, United States

Queen's Cancer Center - PearlridgeRecruiting

‘Aiea, Hawaii 96701, United States

The Queen's Medical Center - West OahuRecruiting

‘Ewa Beach, Hawaii 96706, United States

OSF Saint Anthony's Health CenterRecruiting

Alton, Illinois 62002, United States

Advocate Good Shepherd HospitalRecruiting

Barrington, Illinois 60010, United States

Illinois CancerCare-BloomingtonRecruiting

Bloomington, Illinois 61704, United States

Illinois CancerCare-CantonRecruiting

Canton, Illinois 61520, United States

Memorial Hospital of CarbondaleRecruiting

Carbondale, Illinois 62902, United States

SIH Cancer InstituteRecruiting

Carterville, Illinois 62918, United States

Illinois CancerCare-CarthageRecruiting

Carthage, Illinois 62321, United States

Centralia Oncology ClinicRecruiting

Centralia, Illinois 62801, United States

Advocate Illinois Masonic Medical CenterRecruiting

Chicago, Illinois 60657, United States

AMG Crystal Lake - OncologyRecruiting

Crystal Lake, Illinois 60014, United States

Carle at The RiverfrontRecruiting

Danville, Illinois 61832, United States

Cancer Care Specialists of Illinois - DecaturRecruiting

Decatur, Illinois 62526, United States

Decatur Memorial HospitalRecruiting

Decatur, Illinois 62526, United States

Illinois CancerCare-DixonRecruiting

Dixon, Illinois 61021, United States

Advocate Good Samaritan HospitalRecruiting

Downers Grove, Illinois 60515, United States

Crossroads Cancer CenterRecruiting

Effingham, Illinois 62401, United States

Advocate Sherman HospitalRecruiting

Elgin, Illinois 60123, United States

Illinois CancerCare-EurekaRecruiting

Eureka, Illinois 61530, United States

Illinois CancerCare-GalesburgRecruiting

Galesburg, Illinois 61401, United States

Advocate South Suburban HospitalRecruiting

Hazel Crest, Illinois 60429, United States

Illinois CancerCare-Kewanee ClinicRecruiting

Kewanee, Illinois 61443, United States

AMG Libertyville - OncologyRecruiting

Libertyville, Illinois 60048, United States

Condell Memorial HospitalRecruiting

Libertyville, Illinois 60048, United States

Illinois CancerCare-MacombRecruiting

Macomb, Illinois 61455, United States

Carle BroMenn Medical CenterRecruiting

Normal, Illinois 61761, United States

Carle Cancer Institute NormalRecruiting

Normal, Illinois 61761, United States

Cancer Care Center of O'FallonRecruiting

O'Fallon, Illinois 62269, United States

HSHS Saint Elizabeth's HospitalRecruiting

O'Fallon, Illinois 62269, United States

Advocate Christ Medical CenterRecruiting

Oak Lawn, Illinois 60453-2699, United States

Advocate Outpatient Center - Oak LawnRecruiting

Oak Lawn, Illinois 60453, United States

Illinois CancerCare-Ottawa ClinicRecruiting

Ottawa, Illinois 61350, United States

Advocate Lutheran General HospitalRecruiting

Park Ridge, Illinois 60068, United States

Illinois CancerCare-PekinRecruiting

Pekin, Illinois 61554, United States

Illinois CancerCare-PeoriaRecruiting

Peoria, Illinois 61615, United States

Methodist Medical Center of IllinoisRecruiting

Peoria, Illinois 61636, United States

Illinois CancerCare-PeruRecruiting

Peru, Illinois 61354, United States

Valley Radiation OncologyRecruiting

Peru, Illinois 61354, United States

Illinois CancerCare-PrincetonRecruiting

Princeton, Illinois 61356, United States

Southern Illinois University School of MedicineRecruiting

Springfield, Illinois 62702, United States

Springfield ClinicRecruiting

Springfield, Illinois 62702, United States

Springfield Memorial HospitalRecruiting

Springfield, Illinois 62781, United States

Carle Cancer CenterRecruiting

Urbana, Illinois 61801, United States

Illinois CancerCare - WashingtonRecruiting

Washington, Illinois 61571, United States

Reid HealthActive, not recruiting

Richmond, Indiana 47374, United States

Ochsner Medical Center JeffersonRecruiting

New Orleans, Louisiana 70121, United States

Christiana Care - Union HospitalRecruiting

Elkton, Maryland 21921, United States

Corewell Health Grand Rapids Hospitals - Butterworth HospitalRecruiting

Grand Rapids, Michigan 49503, United States

Trinity Health Grand Rapids HospitalRecruiting

Grand Rapids, Michigan 49503, United States

Dickinson County Healthcare SystemRecruiting

Iron Mountain, Michigan 49801, United States

Bronson Methodist HospitalRecruiting

Kalamazoo, Michigan 49007, United States

West Michigan Cancer CenterRecruiting

Kalamazoo, Michigan 49007, United States

Minnesota Oncology - BurnsvilleRecruiting

Burnsville, Minnesota 55337, United States

Mercy HospitalRecruiting

Coon Rapids, Minnesota 55433, United States

Fairview Southdale HospitalRecruiting

Edina, Minnesota 55435, United States

Fairview Clinics and Surgery Center Maple GroveRecruiting

Maple Grove, Minnesota 55369, United States

Minnesota Oncology Hematology PA-MaplewoodRecruiting

Maplewood, Minnesota 55109, United States

Saint John's Hospital - HealtheastRecruiting

Maplewood, Minnesota 55109, United States

Abbott-Northwestern HospitalRecruiting

Minneapolis, Minnesota 55407, United States

Hennepin County Medical CenterRecruiting

Minneapolis, Minnesota 55415, United States

Monticello Cancer CenterRecruiting

Monticello, Minnesota 55362, United States

New Ulm Medical CenterRecruiting

New Ulm, Minnesota 56073, United States

Fairview Northland Medical CenterRecruiting

Princeton, Minnesota 55371, United States

North Memorial Medical Health CenterRecruiting

Robbinsdale, Minnesota 55422, United States

Park Nicollet Clinic - Saint Louis ParkRecruiting

Saint Louis Park, Minnesota 55416, United States

Regions HospitalRecruiting

Saint Paul, Minnesota 55101, United States

United HospitalRecruiting

Saint Paul, Minnesota 55102, United States

Saint Francis Regional Medical CenterRecruiting

Shakopee, Minnesota 55379, United States

Lakeview HospitalRecruiting

Stillwater, Minnesota 55082, United States

Ridgeview Medical CenterRecruiting

Waconia, Minnesota 55387, United States

Rice Memorial HospitalRecruiting

Willmar, Minnesota 56201, United States

Minnesota Oncology Hematology PA-WoodburyRecruiting

Woodbury, Minnesota 55125, United States

Fairview Lakes Medical CenterRecruiting

Wyoming, Minnesota 55092, United States

Parkland Health Center - FarmingtonRecruiting

Farmington, Missouri 63640, United States

Lake Regional HospitalRecruiting

Osage Beach, Missouri 65065, United States

Sainte Genevieve County Memorial HospitalRecruiting

Sainte Genevieve, Missouri 63670, United States

Mercy Hospital SpringfieldRecruiting

Springfield, Missouri 65804, United States

Mercy Hospital SouthRecruiting

St Louis, Missouri 63128, United States

Missouri Baptist Medical CenterRecruiting

St Louis, Missouri 63131, United States

Missouri Baptist Sullivan HospitalRecruiting

Sullivan, Missouri 63080, United States

BJC Outpatient Center at Sunset HillsRecruiting

Sunset Hills, Missouri 63127, United States

Carson Tahoe Regional Medical CenterRecruiting

Carson City, Nevada 89703, United States

Comprehensive Cancer Centers of Nevada - HendersonRecruiting

Henderson, Nevada 89052, United States

OptumCare Cancer Care at Seven HillsRecruiting

Henderson, Nevada 89052, United States

Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting

Henderson, Nevada 89074, United States

Urology Specialists of Nevada - Green ValleyRecruiting

Henderson, Nevada 89074, United States

OptumCare Cancer Care at CharlestonRecruiting

Las Vegas, Nevada 89102, United States

Urology Specialists of Nevada - SouthwestRecruiting

Las Vegas, Nevada 89113, United States

Comprehensive Cancer Centers of Nevada - NorthwestRecruiting

Las Vegas, Nevada 89128, United States

OptumCare Cancer Care at MountainViewRecruiting

Las Vegas, Nevada 89128, United States

Urology Specialists of Nevada - NorthwestRecruiting

Las Vegas, Nevada 89128, United States

Comprehensive Cancer Centers of Nevada - Town CenterRecruiting

Las Vegas, Nevada 89144, United States

Comprehensive Cancer Centers of Nevada-SummerlinRecruiting

Las Vegas, Nevada 89144, United States

Summerlin Hospital Medical CenterRecruiting

Las Vegas, Nevada 89144, United States

OptumCare Cancer Care at Fort ApacheRecruiting

Las Vegas, Nevada 89148, United States

Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting

Las Vegas, Nevada 89169, United States

Renown Regional Medical CenterRecruiting

Reno, Nevada 89502, United States

Noyes Memorial Hospital/Myers Cancer CenterRecruiting

Dansville, New York 14437, United States

Northwell Health/Center for Advanced MedicineRecruiting

Lake Success, New York 11042, United States

Manhattan Eye Ear and Throat HospitalRecruiting

New York, New York 10065, United States

Lenox Hill HospitalRecruiting

New York, New York 10075, United States

Wilmot Cancer Institute Radiation Oncology at GreeceRecruiting

Rochester, New York 14606, United States

Highland HospitalRecruiting

Rochester, New York 14620, United States

Pluta Cancer CenterRecruiting

Rochester, New York 14623, United States

University of RochesterRecruiting

Rochester, New York 14642, United States

Wilmot Cancer Institute at WebsterRecruiting

Webster, New York 14580, United States

Indu and Raj Soin Medical CenterActive, not recruiting

Beavercreek, Ohio 45431, United States

Strecker Cancer Center-BelpreRecruiting

Belpre, Ohio 45714, United States

Saint Elizabeth Boardman HospitalActive, not recruiting

Boardman, Ohio 44512, United States

Oncology Hematology Care Inc-KenwoodActive, not recruiting

Cincinnati, Ohio 45236, United States

Dayton Physician LLC - EnglewoodActive, not recruiting

Dayton, Ohio 45415, United States

Armes Family Cancer CenterActive, not recruiting

Findlay, Ohio 45840, United States

Blanchard Valley HospitalActive, not recruiting

Findlay, Ohio 45840, United States

Dayton Physicians LLC-AtriumActive, not recruiting

Franklin, Ohio 45005, United States

Wayne HospitalActive, not recruiting

Greenville, Ohio 45331, United States

Greater Dayton Cancer CenterActive, not recruiting

Kettering, Ohio 45409, United States

Kettering Medical CenterActive, not recruiting

Kettering, Ohio 45429, United States

Marietta Memorial HospitalRecruiting

Marietta, Ohio 45750, United States

Dayton Physicians LLC - TroyActive, not recruiting

Troy, Ohio 45373, United States

Saint Joseph Warren HospitalActive, not recruiting

Warren, Ohio 44484, United States

Saint Elizabeth Youngstown HospitalActive, not recruiting

Youngstown, Ohio 44501, United States

Providence Newberg Medical CenterRecruiting

Newberg, Oregon 97132, United States

Providence Willamette Falls Medical CenterRecruiting

Oregon City, Oregon 97045, United States

Providence Portland Medical CenterRecruiting

Portland, Oregon 97213, United States

Providence Saint Vincent Medical CenterRecruiting

Portland, Oregon 97225, United States

Geisinger Medical CenterRecruiting

Danville, Pennsylvania 17822, United States

Geisinger Medical Oncology-LewisburgRecruiting

Lewisburg, Pennsylvania 17837, United States

Geisinger Wyoming Valley/Henry Cancer CenterRecruiting

Wilkes-Barre, Pennsylvania 18711, United States

AnMed Health Cancer CenterRecruiting

Anderson, South Carolina 29621, United States

Saint Joseph's/Candler - Bluffton CampusRecruiting

Bluffton, South Carolina 29910, United States

Gibbs Cancer Center-GaffneyRecruiting

Gaffney, South Carolina 29341, United States

Prisma Health Cancer Institute - ButternutRecruiting

Greenville, South Carolina 29605, United States

Prisma Health Cancer Institute - FarisRecruiting

Greenville, South Carolina 29605, United States

Prisma Health Cancer Institute - EastsideRecruiting

Greenville, South Carolina 29615, United States

Gibbs Cancer Center-PelhamRecruiting

Greer, South Carolina 29651, United States

South Carolina Cancer Specialists PCRecruiting

Hilton Head Island, South Carolina 29926-3827, United States

Spartanburg Medical CenterRecruiting

Spartanburg, South Carolina 29303, United States

SMC Center for Hematology Oncology UnionRecruiting

Union, South Carolina 29379, United States

VCU Community Memorial Health CenterRecruiting

South Hill, Virginia 23970, United States

Shenandoah Oncology PCRecruiting

Winchester, Virginia 22601, United States

PeaceHealth Saint Joseph Medical CenterRecruiting

Bellingham, Washington 98225, United States

PeaceHealth Saint John Medical CenterRecruiting

Longview, Washington 98632, United States

Valley Medical CenterRecruiting

Renton, Washington 98055, United States

PeaceHealth Southwest Medical CenterRecruiting

Vancouver, Washington 98664, United States

ThedaCare Regional Cancer CenterRecruiting

Appleton, Wisconsin 54911, United States

Ascension Saint Elizabeth HospitalRecruiting

Appleton, Wisconsin 54915, United States

Ascension Southeast Wisconsin Hospital - Elmbrook CampusRecruiting

Brookfield, Wisconsin 53045, United States

Aurora Cancer Care-Southern Lakes VLCCRecruiting

Burlington, Wisconsin 53105, United States

Ascension Calumet HospitalRecruiting

Chilton, Wisconsin 53014, United States

Aurora Saint Luke's South ShoreRecruiting

Cudahy, Wisconsin 53110, United States

HSHS Sacred Heart HospitalSuspended

Eau Claire, Wisconsin 54701, United States

Marshfield Medical Center-EC Cancer CenterRecruiting

Eau Claire, Wisconsin 54701, United States

Ascension Saint Francis - Reiman Cancer CenterRecruiting

Franklin, Wisconsin 53132, United States

Aurora Health Care Germantown Health CenterRecruiting

Germantown, Wisconsin 53022, United States

Aurora Cancer Care-GraftonRecruiting

Grafton, Wisconsin 53024, United States

Saint Vincent Hospital Cancer Center Green BayRecruiting

Green Bay, Wisconsin 54301, United States

Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting

Green Bay, Wisconsin 54303, United States

Aurora BayCare Medical CenterRecruiting

Green Bay, Wisconsin 54311, United States

Aurora Health Center - GreenfieldRecruiting

Greenfield, Wisconsin 53228, United States

Aurora Cancer Care-Kenosha SouthRecruiting

Kenosha, Wisconsin 53142, United States

Aurora Bay Area Medical Group-MarinetteRecruiting

Marinette, Wisconsin 54143, United States

Marshfield Medical Center-MarshfieldRecruiting

Marshfield, Wisconsin 54449, United States

Ascension Columbia Saint Mary's Hospital OzaukeeRecruiting

Mequon, Wisconsin 53097, United States

Aurora Cancer Care-MilwaukeeRecruiting

Milwaukee, Wisconsin 53209, United States

Ascension Columbia Saint Mary's Hospital - MilwaukeeRecruiting

Milwaukee, Wisconsin 53211, United States

Aurora Saint Luke's Medical CenterRecruiting

Milwaukee, Wisconsin 53215, United States

Aurora Sinai Medical CenterRecruiting

Milwaukee, Wisconsin 53233, United States

Marshfield Medical Center - MinocquaRecruiting

Minocqua, Wisconsin 54548, United States

Cancer Center of Western WisconsinRecruiting

New Richmond, Wisconsin 54017, United States

Ascension Mercy HospitalRecruiting

Oshkosh, Wisconsin 54904, United States

Vince Lombardi Cancer Clinic - OshkoshRecruiting

Oshkosh, Wisconsin 54904, United States

Ascension All Saints HospitalRecruiting

Racine, Wisconsin 53405, United States

Aurora Cancer Care-RacineRecruiting

Racine, Wisconsin 53406, United States

Marshfield Medical Center-Rice LakeRecruiting

Rice Lake, Wisconsin 54868, United States

Vince Lombardi Cancer Clinic-SheboyganRecruiting

Sheboygan, Wisconsin 53081, United States

Marshfield Medical Center-River Region at Stevens PointRecruiting

Stevens Point, Wisconsin 54482, United States

Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting

Sturgeon Bay, Wisconsin 54235-1495, United States

Aurora Medical Center in SummitRecruiting

Summit, Wisconsin 53066, United States

Site Public ContactContact

ncorp@aurora.org414-302-2304

Vince Lombardi Cancer Clinic-Two RiversRecruiting

Two Rivers, Wisconsin 54241, United States

Ascension Medical Group Southeast Wisconsin - Mayfair RoadRecruiting

Wauwatosa, Wisconsin 53226, United States

Aurora Cancer Care-Milwaukee WestRecruiting

Wauwatosa, Wisconsin 53226, United States

Aurora West Allis Medical CenterRecruiting

West Allis, Wisconsin 53227, United States

Marshfield Medical Center - WestonRecruiting

Weston, Wisconsin 54476, United States