Colorectal Cancer Clinical Trials

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Evaluation of Provider vs. Patient Mediated Cascade Genetic Testing of First-Degree Relatives of Patients With Newly Diagnosed Colorectal Cancer

Status: Recruiting
Location: See all (242) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• STEP 1 PROBANDS: Age \>= 18 years

• STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV

‣ Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into/involve the small bowel (e.g., those at the ileocecal valve). Tumors will be regarded as originating in the colon if the entire tumor is in the colon. In the case of rectal involvement, the cancer will be considered a rectal primary

⁃ Patients with more than one primary colon adenocarcinoma are eligible

• STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer

• STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers

• STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible

• STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes

• STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis

• STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish

• STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members

• \* No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician

• STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene

• FDRs: Age \>= 18 years

• FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes

• FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents

• FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
RECRUITING
Anchorage
Alaska Oncology and Hematology LLC
RECRUITING
Anchorage
Alaska Women's Cancer Care
RECRUITING
Anchorage
Anchorage Associates in Radiation Medicine
RECRUITING
Anchorage
Katmai Oncology Group
RECRUITING
Anchorage
Providence Alaska Medical Center
RECRUITING
Anchorage
Fairbanks Memorial Hospital
RECRUITING
Fairbanks
Arkansas
Mercy Hospital Fort Smith
RECRUITING
Fort Smith
CARTI Cancer Center
RECRUITING
Little Rock
Arizona
Cancer Center at Saint Joseph's
RECRUITING
Phoenix
California
Mission Hope Medical Oncology - Arroyo Grande
RECRUITING
Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center
RECRUITING
Burbank
Mercy Cancer Center - Carmichael
RECRUITING
Carmichael
Mercy San Juan Medical Center
RECRUITING
Carmichael
Mercy Cancer Center - Elk Grove
RECRUITING
Elk Grove
Mercy Cancer Center
RECRUITING
Merced
Providence Queen of The Valley
RECRUITING
Napa
Mercy Cancer Center - Rocklin
RECRUITING
Rocklin
Mercy Cancer Center - Sacramento
RECRUITING
Sacramento
Pacific Central Coast Health Center-San Luis Obispo
RECRUITING
San Luis Obispo
Mission Hope Medical Oncology - Santa Maria
RECRUITING
Santa Maria
Providence Medical Foundation - Santa Rosa
RECRUITING
Santa Rosa
Providence Santa Rosa Memorial Hospital
RECRUITING
Santa Rosa
Saint Helena Hospital
RECRUITING
St. Helena
Saint Joseph's Medical Center
RECRUITING
Stockton
Woodland Memorial Hospital
RECRUITING
Woodland
Colorado
Penrose-Saint Francis Healthcare
RECRUITING
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
RECRUITING
Colorado Springs
Saint Francis Cancer Center
RECRUITING
Colorado Springs
CommonSpirit Cancer Center Mercy
RECRUITING
Durango
Mercy Medical Center
RECRUITING
Durango
CommonSpirit Saint Anthony Hospital Cancer Center
RECRUITING
Lakewood
Longmont United Hospital
RECRUITING
Longmont
Saint Mary Corwin Medical Center
RECRUITING
Pueblo
Saint Anthony North Hospital
RECRUITING
Westminster
Florida
Holy Cross Hospital
RECRUITING
Fort Lauderdale
Idaho
Saint Alphonsus Cancer Care Center-Boise
RECRUITING
Boise
Saint Luke's Cancer Institute - Boise
RECRUITING
Boise
Saint Alphonsus Cancer Care Center-Caldwell
RECRUITING
Caldwell
Kootenai Health - Coeur d'Alene
RECRUITING
Coeur D'alene
Saint Luke's Cancer Institute - Fruitland
RECRUITING
Fruitland
Idaho Urologic Institute-Meridian
RECRUITING
Meridian
Saint Luke's Cancer Institute - Meridian
RECRUITING
Meridian
Saint Alphonsus Cancer Care Center-Nampa
RECRUITING
Nampa
Saint Luke's Cancer Institute - Nampa
RECRUITING
Nampa
Kootenai Clinic Cancer Services - Post Falls
RECRUITING
Post Falls
Kootenai Clinic Cancer Services - Sandpoint
RECRUITING
Sandpoint
Saint Luke's Cancer Institute - Twin Falls
RECRUITING
Twin Falls
Illinois
OSF Saint Anthony's Health Center
RECRUITING
Alton
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Memorial Hospital of Carbondale
RECRUITING
Carbondale
SIH Cancer Institute
RECRUITING
Carterville
Illinois CancerCare-Carthage
RECRUITING
Carthage
Centralia Oncology Clinic
RECRUITING
Centralia
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Illinois CancerCare-Dixon
RECRUITING
Dixon
Crossroads Cancer Center
RECRUITING
Effingham
Illinois CancerCare-Eureka
RECRUITING
Eureka
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Illinois CancerCare-Macomb
RECRUITING
Macomb
SSM Health Good Samaritan
RECRUITING
Mount Vernon
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
HSHS Saint Elizabeth's Hospital
RECRUITING
O'fallon
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Methodist Medical Center of Illinois
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Valley Radiation Oncology
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
OSF Saint Anthony Medical Center
RECRUITING
Rockford
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Illinois CancerCare - Washington
RECRUITING
Washington
Kansas
Central Care Cancer Center - Garden City
RECRUITING
Garden City
Central Care Cancer Center - Great Bend
RECRUITING
Great Bend
Mercy Hospital Pittsburg
RECRUITING
Pittsburg
Cotton O'Neil Cancer Center / Stormont Vail Health
RECRUITING
Topeka
Kentucky
Flaget Memorial Hospital
RECRUITING
Bardstown
Commonwealth Cancer Center-Corbin
RECRUITING
Corbin
Saint Joseph Hospital
RECRUITING
Lexington
Saint Joseph Hospital East
RECRUITING
Lexington
Saint Joseph Radiation Oncology Resource Center
RECRUITING
Lexington
Saint Joseph London
RECRUITING
London
Saint Joseph Mount Sterling
RECRUITING
Mount Sterling
Maryland
Sinai Hospital of Baltimore
RECRUITING
Baltimore
Northwest Hospital Center
RECRUITING
Randallstown
UM Saint Joseph Medical Center
RECRUITING
Towson
William E Kahlert Regional Cancer Center/Sinai Hospital
RECRUITING
Westminster
Michigan
MyMichigan Medical Center Gratiot
RECRUITING
Alma
MyMichigan Medical Center Alpena
RECRUITING
Alpena
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health Medical Center - Brighton
RECRUITING
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health Medical Center - Canton
RECRUITING
Canton
Chelsea Hospital
RECRUITING
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
Hematology Oncology Consultants-Clarkston
RECRUITING
Clarkston
Newland Medical Associates-Clarkston
SUSPENDED
Clarkston
Henry Ford Health Saint John Hospital
RECRUITING
Detroit
Henry Ford River District Hospital
RECRUITING
East China Township
Cancer Hematology Centers - Flint
RECRUITING
Flint
Genesee Hematology Oncology PC
RECRUITING
Flint
Genesys Hurley Cancer Institute
RECRUITING
Flint
Hurley Medical Center
RECRUITING
Flint
MyMichigan Medical Center Gladwin
RECRUITING
Gladwin
Henry Ford Saint John Hospital - Academic
RECRUITING
Grosse Pointe Woods
Henry Ford Saint John Hospital - Breast
RECRUITING
Grosse Pointe Woods
Henry Ford Saint John Hospital - Van Elslander
RECRUITING
Grosse Pointe Woods
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Henry Ford Saint John Hospital - Macomb Medical
RECRUITING
Macomb
Henry Ford Warren Hospital - Breast Macomb
RECRUITING
Macomb
MyMichigan Medical Center Midland
RECRUITING
Midland
MyMichigan Medical Center Mount Pleasant
RECRUITING
Mount Pleasant
Hope Cancer Center
RECRUITING
Pontiac
Michigan Healthcare Professionals Pontiac
RECRUITING
Pontiac
Newland Medical Associates-Pontiac
RECRUITING
Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
MyMichigan Medical Center Saginaw
RECRUITING
Saginaw
MyMichigan Medical Center Tawas
RECRUITING
Tawas City
Henry Ford Health Warren Hospital
RECRUITING
Warren
Henry Ford Madison Heights Hospital - Breast
RECRUITING
Warren
Henry Ford Warren Hospital - GLCMS
RECRUITING
Warren
Huron Gastroenterology PC
RECRUITING
Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Minnesota Oncology - Burnsville
RECRUITING
Burnsville
Minnesota Oncology Hematology PA-Chaska
RECRUITING
Chaska
Mercy Hospital
RECRUITING
Coon Rapids
Minnesota Oncology - Coon Rapids
RECRUITING
Coon Rapids
Fairview Southdale Hospital
RECRUITING
Edina
Minnesota Oncology - Edina
RECRUITING
Edina
Fairview Clinics and Surgery Center Maple Grove
RECRUITING
Maple Grove
Minnesota Oncology - Maple Grove
RECRUITING
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
RECRUITING
Maplewood
Saint John's Hospital - Healtheast
RECRUITING
Maplewood
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
Hennepin County Medical Center
RECRUITING
Minneapolis
New Ulm Medical Center
RECRUITING
New Ulm
Fairview Northland Medical Center
RECRUITING
Princeton
North Memorial Medical Health Center
RECRUITING
Robbinsdale
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Saint Francis Regional Medical Center
RECRUITING
Shakopee
Lakeview Hospital
RECRUITING
Stillwater
Ridgeview Medical Center
RECRUITING
Waconia
Rice Memorial Hospital
RECRUITING
Willmar
Minnesota Oncology Hematology PA-Woodbury
RECRUITING
Woodbury
Fairview Lakes Medical Center
RECRUITING
Wyoming
Missouri
Mercy Oncology and Hematology - Clayton-Clarkson
RECRUITING
Ballwin
Central Care Cancer Center - Bolivar
RECRUITING
Bolivar
Cox Cancer Center Branson
RECRUITING
Branson
Mercy Cancer Center - Cape Girardeau
RECRUITING
Cape Girardeau
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Parkland Health Center - Farmington
RECRUITING
Farmington
Freeman Health System
RECRUITING
Joplin
Mercy Hospital Joplin
RECRUITING
Joplin
Lake Regional Hospital
RECRUITING
Osage Beach
Mercy Clinic-Rolla-Cancer and Hematology
RECRUITING
Rolla
Phelps Health Delbert Day Cancer Institute
RECRUITING
Rolla
Heartland Regional Medical Center
RECRUITING
Saint Joseph
Sainte Genevieve County Memorial Hospital
RECRUITING
Sainte Genevieve
CoxHealth South Hospital
RECRUITING
Springfield
Mercy Hospital Springfield
RECRUITING
Springfield
Mercy Hospital Saint Louis
RECRUITING
St Louis
Mercy Hospital South
RECRUITING
St Louis
Mercy Infusion Center - Chippewa
RECRUITING
St Louis
Missouri Baptist Medical Center
RECRUITING
St Louis
Missouri Baptist Sullivan Hospital
RECRUITING
Sullivan
BJC Outpatient Center at Sunset Hills
RECRUITING
Sunset Hills
Mercy Hospital Washington
RECRUITING
Washington
Montana
Community Hospital of Anaconda
RECRUITING
Anaconda
Billings Clinic Cancer Center
RECRUITING
Billings
Bozeman Health Deaconess Hospital
RECRUITING
Bozeman
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Great Falls Clinic
RECRUITING
Great Falls
Hi-Line Sletten Cancer Center
RECRUITING
Havre
Benefis Helena Specialty Center
RECRUITING
Helena
Logan Health Medical Center
RECRUITING
Kalispell
Community Medical Center
RECRUITING
Missoula
Saint Patrick Hospital - Community Hospital
RECRUITING
Missoula
North Carolina
CaroMont Regional Medical Center
RECRUITING
Gastonia
CaroMont Health - Lincoln Cancer Center
RECRUITING
Lincolnton
Nebraska
CHI Health Saint Francis
RECRUITING
Grand Island
CHI Health Good Samaritan
RECRUITING
Kearney
Alegent Health Bergan Mercy Medical Center
RECRUITING
Omaha
Alegent Health Immanuel Medical Center
RECRUITING
Omaha
Alegent Health Lakeside Hospital
RECRUITING
Omaha
Ohio
Aultman Alliance Community Hospital
RECRUITING
Alliance
Aultman Health Foundation
RECRUITING
Canton
Bethesda North Hospital
RECRUITING
Cincinnati
Good Samaritan Hospital - Cincinnati
RECRUITING
Cincinnati
TriHealth Cancer Institute-Anderson
RECRUITING
Cincinnati
TriHealth Cancer Institute-Westside
RECRUITING
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
RECRUITING
Cincinnati
University of Cincinnati Cancer Center-West Chester
RECRUITING
West Chester
Oklahoma
Mercy Hospital Oklahoma City
RECRUITING
Oklahoma City
Oregon
Saint Alphonsus Cancer Care Center-Baker City
RECRUITING
Baker City
Saint Charles Health System
RECRUITING
Bend
Clackamas Radiation Oncology Center
RECRUITING
Clackamas
Bay Area Hospital
RECRUITING
Coos Bay
Providence Hood River Memorial Hospital
RECRUITING
Hood River
Providence Newberg Medical Center
RECRUITING
Newberg
Saint Alphonsus Cancer Care Center-Ontario
RECRUITING
Ontario
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Saint Charles Health System-Redmond
RECRUITING
Redmond
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
RECRUITING
Allentown
Lehigh Valley Hospital - Muhlenberg
RECRUITING
Bethlehem
Pocono Medical Center
RECRUITING
East Stroudsburg
Lehigh Valley Hospital-Hazleton
RECRUITING
Hazleton
South Dakota
Rapid City Regional Hospital
RECRUITING
Rapid City
Washington
Providence Regional Cancer System-Aberdeen
RECRUITING
Aberdeen
PeaceHealth Saint Joseph Medical Center
RECRUITING
Bellingham
Providence Regional Cancer System-Centralia
RECRUITING
Centralia
Swedish Cancer Institute-Edmonds
RECRUITING
Edmonds
Providence Regional Cancer Partnership
RECRUITING
Everett
Swedish Cancer Institute-Issaquah
RECRUITING
Issaquah
Kadlec Clinic Hematology and Oncology
RECRUITING
Kennewick
Providence Regional Cancer System-Lacey
RECRUITING
Lacey
PeaceHealth Saint John Medical Center
RECRUITING
Longview
Skagit Regional Health Cancer Care Center
RECRUITING
Mount Vernon
Swedish Medical Center-Ballard Campus
RECRUITING
Seattle
Swedish Medical Center-Cherry Hill
RECRUITING
Seattle
Swedish Medical Center-First Hill
RECRUITING
Seattle
PeaceHealth United General Medical Center
RECRUITING
Sedro-woolley
Saint Joseph Medical Center Hematology and Oncology - Silverdale
RECRUITING
Silverdale
Cancer Care Northwest - Spokane South
RECRUITING
Spokane
Cancer Care Northwest-North Spokane
RECRUITING
Spokane
Cancer Care Northwest-Valley
RECRUITING
Spokane
PeaceHealth Southwest Medical Center
RECRUITING
Vancouver
Providence Saint Mary Regional Cancer Center
RECRUITING
Walla Walla
Wisconsin
Cancer Center of Western Wisconsin
RECRUITING
New Richmond
Wyoming
Memorial Hospital of Laramie County
RECRUITING
Cheyenne
Billings Clinic-Cody
RECRUITING
Cody
Contact Information
Primary
Rachel Wills
rwills@bsd.uchicago.edu
773-702-9814
Time Frame
Start Date: 2026-04-06
Estimated Completion Date: 2032-11-05
Participants
Target number of participants: 4186
Treatments
Experimental: Step 1 (biospecimen collection, genetic testing)
Probands undergo collection of blood samples and genetic testing on study.
Active_comparator: Step 2, Arm A (proband-mediated)
FDRs receive proband-mediated communication about the proband's genetic testing results.
Experimental: Step 2, Arm B (provider-mediated)
FDRs receive provider-mediated communication about the proband's genetic testing results.
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov