A Study of CDPATH™ to Help Manage and Treat Crohn's Disease

Study Purpose

CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant's risk profile and to have discussions with their doctor about the potential path of their Crohn's disease. The number of visits will be decided by the study clinic according to their standard practice.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Has an initial diagnosis of CD established within five years prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report (if available). 2. Has agreed to use the CDPATH™ tool. 3. Has reliable access to the internet and is willing to answer electronic patient-reported outcomes (ePROs) throughout the study.

Exclusion Criteria:

1. Has had known complications from CD including but not limited to: bowel stricture, CD-related intra-abdominal abscess, internal penetrating disease (known fistula other than perianal fistula), non-perianal surgery, bowel resection, or stricturoplasty. A perianal fistula or abscess without other signs of penetrating disease is allowed. 2. Has had any non-CD-related abdominal surgery. 3. Has received investigational biologic or nonbiologic agents for the treatment of CD in an investigational protocol. Approved biologic or nonbiologic agents for CD are allowed. 4. Has previously used CDPATH™ or PROSPECT results to assess CD risk for complications.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04809363
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Study Website: View Trial Website
Additional Details

The tool being tested in this study is called CDPATH™. CDPATH™ is being used to provide a graphical representation of an individual participant's risk of developing a CD-related complication within three years, leveraging known participant risk factors based on clinical, serologic and genetic variables to help people categorize risk who have CD. This study will gather data on the use of the tool in real-world settings to inform practical use of CDPATH™. The study will enroll approximately 200 patients. Participants and health care providers (HCPs) will be surveyed to understand their satisfaction with the CDPATH™ process and with their treatment choice. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 36 months. Participants will make multiple visits to the HCP's clinic, and data will be collected approximately every six months up to 3 years, based on the timing of routine follow-up appointments for assessment.

Arms & Interventions

Arms

Experimental: CDPATH™

Participants with CD will be using CDPATH™ tool. Clinical data will be collected via an ongoing registry. Participants and health care provider (HCP)-reported outcomes data will be collected periodically once every 6 months for up to 36 months via electronic surveys. Two baseline blood samples will be collected at screening for CDPATH™ analysis. 1 additional sample will be collected for future potential biomarker analysis.

Interventions

Other: - CDPATH™

Crohn's disease risk prediction tool.

Other: - Blood Draw

Three blood samples will be drawn.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research, PLLC

Phoenix, Arizona, 85032

VA Loma Linda Healthcare System, Loma Linda, California

Status

Recruiting

Address

VA Loma Linda Healthcare System

Loma Linda, California, 92354

Site Contact

Site Contact

muhammad.hammami@va.gov

909-825-7084

United Medical Doctors, Murrieta, California

Status

Recruiting

Address

United Medical Doctors

Murrieta, California, 92563

Site Contact

Site Contact

drhongpi@unitedmd.com

562-430-4449

Newport Beach, California

Status

Recruiting

Address

University of Southern California Medical Center

Newport Beach, California, 92663

Site Contact

Site Contact

caroline.hwang@hoag.org

949-557-0251

Clinnova Research, Orange, California

Status

Recruiting

Address

Clinnova Research

Orange, California, 92868

Site Contact

Site Contact

abhanvadia.cr@gmail.com

949-354-5353

Orange, California

Status

Recruiting

Address

University of California at Irvine Medical Center

Orange, California, 92868

Site Contact

Site Contact

parekhn@hs.uci.edu

888-717-4463 #7144567358

Kaiser Permanate of Colorado, Aurora, Colorado

Status

Recruiting

Address

Kaiser Permanate of Colorado

Aurora, Colorado, 80014

Site Contact

Site Contact

christopher.j.shepela@kp.org

303-720-2685

Hamden, Connecticut

Status

Recruiting

Address

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518

Clearwater, Florida

Status

Recruiting

Address

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33762

Site Contact

Site Contact

uchoudhry@gastrofl.com

727-347-0005

Pensacola, Florida

Status

Recruiting

Address

Gastroenterology Associates of Pensacola, PA

Pensacola, Florida, 32503

Site Contact

Site Contact

fnewman@gastrohealth.com

850-436-4536

Tampa, Florida

Status

Recruiting

Address

West Central Gastroenterology d/b/a Gastro Florida

Tampa, Florida, 33626

Site Contact

Site Contact

aawad@gastrofl.com

727-347-0005

Emory Healthcare, Atlanta, Georgia

Status

Not yet recruiting

Address

Emory Healthcare

Atlanta, Georgia, 30322

Site Contact

Site Contact

tdhere@emory.edu

404-778-3184

Grand Teton Research Group, PLL, Idaho Falls, Idaho

Status

Recruiting

Address

Grand Teton Research Group, PLL

Idaho Falls, Idaho, 83404

Site Contact

Site Contact

scott@gtrgi.org

208-522-4000

GI Alliance, Arlington Heights, Illinois

Status

Recruiting

Address

GI Alliance

Arlington Heights, Illinois, 60005

Site Contact

Site Contact

mbernsen@illinoisgastro.com

847-439-1005

University of Chicago Medical Center, Chicago, Illinois

Status

Not yet recruiting

Address

University of Chicago Medical Center

Chicago, Illinois, 60637

GI Alliance, Gurnee, Illinois

Status

Recruiting

Address

GI Alliance

Gurnee, Illinois, 60031

Comprehensive Gastrointestinal Health, Northbrook, Illinois

Status

Recruiting

Address

Comprehensive Gastrointestinal Health

Northbrook, Illinois, 60062

Site Contact

Site Contact

jnathanson@compgihealth.com

224-407-4400

Rockford, Illinois

Status

Recruiting

Address

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107

Indiana University, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University

Indianapolis, Indiana, 46202

Site Contact

Site Contact

mofische@iu.edu

317-944-3332

Iowa Digestive Disease Center, Clive, Iowa

Status

Recruiting

Address

Iowa Digestive Disease Center

Clive, Iowa, 50325

University Of Iowa Hospital and Clinics, Iowa City, Iowa

Status

Recruiting

Address

University Of Iowa Hospital and Clinics

Iowa City, Iowa, 52242

Site Contact

Site Contact

steven-polyak@uiowa.edu

319-384-6336

Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160

Site Contact

Site Contact

faslinia@kumc.edu

913-588-6158 #9135886019

GI Alliance - Baton Rouge, Baton Rouge, Louisiana

Status

Recruiting

Address

GI Alliance - Baton Rouge

Baton Rouge, Louisiana, 70809

Site Contact

Site Contact

jchapman@tddctx.com

225-927-1190 #7850

Louisiana Research Center, LLC, Shreveport, Louisiana

Status

Recruiting

Address

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105

Site Contact

Site Contact

haguilar@gis.md

318-631-9121

Baltimore, Maryland

Status

Not yet recruiting

Address

University of Maryland School of Medicine.

Baltimore, Maryland, 21201

Site Contact

Site Contact

spatil@som.umaryland.edu

410-706-3387

Gastro Center of Maryland, Columbia, Maryland

Status

Recruiting

Address

Gastro Center of Maryland

Columbia, Maryland, 21045

Site Contact

Site Contact

rrai@gastromaryland.com

410-290-6677

Lahey Clinic Inc. - PARENT ACCOUNT, Burlington, Massachusetts

Status

Recruiting

Address

Lahey Clinic Inc. - PARENT ACCOUNT

Burlington, Massachusetts, 01805

Site Contact

Site Contact

randall.pellish@lahey.org

781-744-8740

UMASS Memorial Medical Center, Worcester, Massachusetts

Status

Recruiting

Address

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655

Troy, Michigan

Status

Recruiting

Address

Digestive Health to Clinical Research Institute of Michigan (CRIM)

Troy, Michigan, 48098

Wyoming, Michigan

Status

Recruiting

Address

Gastroenterology Associates of Western Michigan, P.L.C.

Wyoming, Michigan, 49519

Site Contact

Site Contact

acoates@gastro-assoc-wm.com

616-328-5344

BVL Clinical Research, Liberty, Missouri

Status

Recruiting

Address

BVL Clinical Research

Liberty, Missouri, 64068

Site Contact

Site Contact

c.bartalos@bvlresearch.com

800-407-9314

University of New Mexico, Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico

Albuquerque, New Mexico, 87131

Site Contact

Site Contact

spaleti@salud.unm.edu

505-272-6225

Lenox Hill Hospital, New York, New York

Status

Recruiting

Address

Lenox Hill Hospital

New York, New York, 10075

Site Contact

Site Contact

aswaminath@northwell.edu

212-434-6785

Wake Forest Baptist Health, Winston-Salem, North Carolina

Status

Not yet recruiting

Address

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157

Site Contact

Site Contact

pagreen@wakehealth.edu

336-713-7331

Clinical Inquest Center Ltd, Beavercreek, Ohio

Status

Recruiting

Address

Clinical Inquest Center Ltd

Beavercreek, Ohio, 45431

Site Contact

Site Contact

daniel@cic-america.com

937-429-2422

Dayton Gastroenterology, Inc, Dayton, Ohio

Status

Recruiting

Address

Dayton Gastroenterology, Inc

Dayton, Ohio, 45415

Site Contact

Site Contact

ikramuddin@daytongastro.com

937-320-5050

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Site Contact

Site Contact

kfriedenberg@thectnx.com

440-205-1225

Digestive Disease Specialists, Inc., Oklahoma City, Oklahoma

Status

Recruiting

Address

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, 73122

Site Contact

Site Contact

david.stokesberry@okddsi.net

405-702-1246

The Oregon Clinic, P.C., Portland, Oregon

Status

Recruiting

Address

The Oregon Clinic, P.C.

Portland, Oregon, 97220

Site Contact

Site Contact

pkiyasu@orclinic.com

503-963-2707

Susquehanna Research Group, LLC, Camp Hill, Pennsylvania

Status

Recruiting

Address

Susquehanna Research Group, LLC

Camp Hill, Pennsylvania, 17011

Site Contact

Site Contact

lsurace@gicare.com

717-914-7770

Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Allegheny Center for Digestive Health, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Allegheny Center for Digestive Health

Pittsburgh, Pennsylvania, 15212

Site Contact

Site Contact

sandra.elhachem@ahn.org

412-578-5676

Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, 15213

Site Contact

Site Contact

schwartzm@upmc.edu

773-597-8533

Frontier Clinical Research, LLC, Smithfield, Pennsylvania

Status

Not yet recruiting

Address

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478

Site Contact

Site Contact

fruthardtresearch@yahoo.com

724-550-4099

Summerville, South Carolina

Status

Recruiting

Address

Palmetto Primary Care Physician Division of Gastroenterology

Summerville, South Carolina, 29486

Site Contact

Site Contact

bvanleer1@gmail.com

843-376-0670

Rapid City Medical Center, LLC, Rapid City, South Dakota

Status

Recruiting

Address

Rapid City Medical Center, LLC

Rapid City, South Dakota, 57701

Site Contact

Site Contact

gitex66@gmail.com

605-721-8181

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Not yet recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37204

The University of Texas at Austin, Austin, Texas

Status

Recruiting

Address

The University of Texas at Austin

Austin, Texas, 78712

Baylor College of Medicine, Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine

Houston, Texas, 77030

Site Contact

Site Contact

rshukla@bcm.edu

713-798-8220

GI Alliance - Southlake, Southlake, Texas

Status

Recruiting

Address

GI Alliance - Southlake

Southlake, Texas, 76092

Site Contact

Site Contact

tim.ritter@gialliance.com

817-612-5575

Care Access Research LLC, Ogden, Utah

Status

Recruiting

Address

Care Access Research LLC

Ogden, Utah, 84403

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84132

Site Contact

Site Contact

ann.flynn@hsc.utah.edu

801-587-7678

GCGA Physicians LLC, Fairfax, Virginia

Status

Recruiting

Address

GCGA Physicians LLC

Fairfax, Virginia, 22031

Site Contact

Site Contact

kmirkin@novagi.com

703-698-8960

Gastroenterology Associates, Lynchburg, Virginia

Status

Recruiting

Address

Gastroenterology Associates

Lynchburg, Virginia, 24502

Site Contact

Site Contact

l.clark@gastrocentralva.com

434-455-8670

Washington Gastroenterology, Bellevue, Washington

Status

Recruiting

Address

Washington Gastroenterology

Bellevue, Washington, 98405

Site Contact

Site Contact

vmohan@washgi.com

425-452-8547