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

Care Access Research LLC, Berkeley, California

Status

Recruiting

Address

Care Access Research LLC

Berkeley, California, 94705

Irvine, California

Status

Not yet recruiting

Address

University of Southern California Medical Center

Irvine, California, 92618

Site Contact

Site Contact

caroline.hwang@hoag.org

949-557-0251

VA Loma Linda Healthcare System, Loma Linda, California

Status

Not yet recruiting

Address

VA Loma Linda Healthcare System

Loma Linda, California, 92354

Site Contact

Site Contact

bader.hammami@medsch.ucr.edu

909-825-7084

United Medical Doctors, Los Alamitos, California

Status

Recruiting

Address

United Medical Doctors

Los Alamitos, California, 90720

Site Contact

Site Contact

john.hong@unitedmd.com

562-430-4449

UCLA Medical Center Gastro, Los Angeles, California

Status

Not yet recruiting

Address

UCLA Medical Center Gastro

Los Angeles, California, 90024

Site Contact

Site Contact

jsauk@mednet.ucla.edu

855-423-8252

Orange, California

Status

Not yet 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, Englewood, Colorado

Status

Recruiting

Address

Kaiser Permanate of Colorado

Englewood, Colorado, 80113

Site Contact

Site Contact

christopher.j.shepela@kp.org

303-649-5838

Hamden, Connecticut

Status

Recruiting

Address

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518

Clearwater, Florida

Status

Not yet 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

drnewman@drnewmangi.com

850-436-4536

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

University of Chicago Medical Center, Chicago, Illinois

Status

Not yet recruiting

Address

University of Chicago Medical Center

Chicago, Illinois, 60637

Site Contact

Site Contact

drubin@uchicago.edu

773-834-7414

Rockford, Illinois

Status

Recruiting

Address

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107

Indiana University, Indianapolis, Indiana

Status

Not yet 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

Not yet 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, 66205

Site Contact

Site Contact

faslinia@kumc.edu

913-588-6158 #9135886019

Louisiana Research Center, LLC, Shreveport, Louisiana

Status

Recruiting

Address

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105

Site Contact

Site Contact

haguilar@gis.md

318-525-3233

Lahey Clinic Inc., Burlington, Massachusetts

Status

Not yet recruiting

Address

Lahey Clinic Inc.

Burlington, Massachusetts, 01805

Site Contact

Site Contact

randall.pellish@lahey.org

781-744-8740

Center for Digestive Health, Troy, Michigan

Status

Not yet recruiting

Address

Center for Digestive Health

Troy, Michigan, 48098

Site Contact

Site Contact

jweberres@gmail.com

248-267-8485

Morristown, New Jersey

Status

Not yet recruiting

Address

Atlantic Digestive Health Institute at Morristown

Morristown, New Jersey, 07960

University of New Mexico, Albuquerque, New Mexico

Status

Not yet recruiting

Address

University of New Mexico

Albuquerque, New Mexico, 87131

Site Contact

Site Contact

spaleti@salud.unm.edu

505-272-6225

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

Dayton Gastroenterology, Inc, Dayton, Ohio

Status

Not yet recruiting

Address

Dayton Gastroenterology, Inc

Dayton, Ohio, 45415

Site Contact

Site Contact

mgorsky@daytongastro.com

937-320-5050

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

Allegheny Center for Digestive Health, Pittsburgh, Pennsylvania

Status

Not yet recruiting

Address

Allegheny Center for Digestive Health

Pittsburgh, Pennsylvania, 15212

Site Contact

Site Contact

sandra.elhachem@ahn.org

412-578-5676

Pittsburgh, Pennsylvania

Status

Not yet recruiting

Address

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, 15213

Site Contact

Site Contact

schwartzm@upmc.edu

412-578-9533

Gastroenterology Associates, PA, Greenville, South Carolina

Status

Not yet recruiting

Address

Gastroenterology Associates, PA

Greenville, South Carolina, 29615

Site Contact

Site Contact

skimmd@gastroassociates.com

864-232-7338

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Not yet recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

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

Not yet recruiting

Address

Baylor College of Medicine

Houston, Texas, 77030

Site Contact

Site Contact

rshukla@bcm.edu

713-798-8220

Pinnacle Clinical Research, PLLC, San Antonio, Texas

Status

Not yet recruiting

Address

Pinnacle Clinical Research, PLLC

San Antonio, Texas, 78229

Site Contact

Site Contact

raviganeshappa@gmail.com

210-982-0320

Southlake, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, 76092

Site Contact

Site Contact

tim.ritter@gialliance.com

817-394-4300

Southlake, Texas

Status

Not yet recruiting

Address

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance

Southlake, Texas, 76092

Site Contact

Site Contact

mbernsen@illinoisgastro.com

847-439-1005

Southlake, Texas

Status

Not yet recruiting

Address

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance

Southlake, Texas, 76092

University of Utah, Salt Lake City, Utah

Status

Not yet recruiting

Address

University of Utah

Salt Lake City, Utah, 84132

Fairfax, Virginia

Status

Not yet recruiting

Address

Gastroenterology Associates of Northern Virginia, Ltd.

Fairfax, Virginia, 22031

Site Contact

Site Contact

kmirkin@gastrohealth.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

Carilion Clinic, Roanoke, Virginia

Status

Not yet recruiting

Address

Carilion Clinic

Roanoke, Virginia, 24014

Site Contact

Site Contact

mvchitnavis@carilionclinic.org

540-224-5170

Washington Gastroenterology, Bellevue, Washington

Status

Not yet recruiting

Address

Washington Gastroenterology

Bellevue, Washington, 98405

Site Contact

Site Contact

vmohan@washgi.com

425-452-8547

Seattle, Washington

Status

Not yet recruiting

Address

University of Washington School of Medicine

Seattle, Washington, 98195

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