Genetic Collection Protocol

NCT ID: NCT05272319

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-06

Study Completion Date

2029-05-31

Brief Summary

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This study involves the one-time collection of whole blood or saliva samples for the extraction and storage of DNA for use in ongoing and future ChiLDReN studies.

Detailed Description

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The purpose of this study is to establish a mechanism to collect a genetic biosample from the participants previously enrolled into clinical research under ChiLDReN-supported protocols (PROBE and BASIC). The samples will be linked to the data previously collected on the participant. Samples will be stored in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) specimen repository and will be used in ongoing and future Network and Ancillary Studies of ChiLDReN to further address the pathophysiology and outcomes of these liver diseases.

Conditions

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Liver Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* For Child Participants

1. Previous enrollment in PROBE or BASIC
2. Exited from one of the aforementioned studies.
3. Consent for DNA sample collection obtained during enrollment during enrollment to one of the aforementioned studies but sample not previously collected.
4. Still followed at the clinical site.

Exclusion Criteria

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1. Participant is deceased
2. Participant exited from prior study due to violating eligibility criteria
3. Participant cannot be contacted
Minimum Eligible Age

24 Hours

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arbor Research Collaborative for Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ed Doo, MD

Role: STUDY_DIRECTOR

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Katrina Loh, MD

Role: STUDY_DIRECTOR

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

John Magee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Lisa Henn, PhD

Role: PRINCIPAL_INVESTIGATOR

Arbor Research Collaborative for Health

Locations

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Children's Hospital of Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

UCSF Benioff Children's Hospital

San Francisco, California, United States

Site Status COMPLETED

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status RECRUITING

Lurie Children's Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status COMPLETED

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status RECRUITING

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Texas Children's Hospital; Baylor College of Medicine

Houston, Texas, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status COMPLETED

Countries

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United States Canada

Central Contacts

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Terese A Howell, BS

Role: CONTACT

734-476-5340

Melissa Sexton, BBA

Role: CONTACT

734-693-3811

Facility Contacts

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Sirikorn Boonsawat

Role: primary

(323) 361-2181

Kelly Gilmartin

Role: primary

(720)-777-2961

Michelle Landis

Role: backup

720-777-8884

Katelynn Harris

Role: primary

404-785-0421

Jordyn Turner

Role: backup

404-785-3690

Angela Anthony

Role: primary

(312) 227-4559

Jacqueline Alexander

Role: backup

312-227-3523

Erin Chapman

Role: primary

(513) 803-7482

Jennifer Hawkins

Role: backup

(513) 636-7818

Caitlin Griffiths, MS

Role: primary

267-577-9888

Chigozie Amonu

Role: backup

267-603-2396

Audrey Fitzgerald

Role: primary

412-692-3378

Susan Richey

Role: backup

412-692-6337

Laurel Cavallo

Role: primary

832-822-1053

Cynthia Tsai

Role: backup

832-822-3634

Ann Rutherford

Role: primary

(801) 585-9495

Natalie Fillerup

Role: backup

801-587-5670

Melissa Young

Role: primary

(206) 987-1037

Other Identifiers

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Genetic Collection - ChiLDReN

Identifier Type: -

Identifier Source: org_study_id

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