Genetic Collection Protocol
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| ClinicalTrials.gov Identifier: NCT05272319 |
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Recruitment Status :
Recruiting
First Posted : March 9, 2022
Last Update Posted : April 22, 2022
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Sponsor:
Arbor Research Collaborative for Health
Information provided by (Responsible Party):
Arbor Research Collaborative for Health
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Brief Summary:
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.
| Condition or disease |
|---|
| Liver Diseases |
The purpose of this study is to establish a mechanism to collect a genetic biosample from the participants and their biological parents previously enrolled into clinical research under ChiLDReN-supported protocols (PROBE, BASIC, LOGIC, and MITOHEP). 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.
| Study Type : | Observational |
| Estimated Enrollment : | 2230 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | Genetic Collection Protocol |
| Actual Study Start Date : | April 6, 2022 |
| Estimated Primary Completion Date : | May 31, 2024 |
| Estimated Study Completion Date : | May 31, 2024 |
Primary Outcome Measures :
- Augment a repository of DNA [ Time Frame: beginning of study through study completion, an average of 1 year. ]The major objective of this protocol is to augment a repository of DNA from participants and their biological parents previously enrolled into clinical research but for whom a DNA biosample was not previously collected. The acquisition and storage of DNA from participants and their biological parents will make available an important resource for future and ongoing studies that may evaluate etiology, pathogenesis, biomarkers, pharmacogenomics, and genetic modifiers of these rare disorders.
Biospecimen Retention: Samples With DNA
Participants will have one-time collection of whole blood or saliva for DNA
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
Study Population
The eligible study population are those child participants who signed consent to participate in a prior research study that collects DNA biospecimens and for whom the specimen was never obtained. If those participants are still followed by the site. Biological parents of previously consented child participants without collection of a parental DNA biospecimen will also be included, if their child is still followed by the site.
Criteria
Inclusion Criteria:
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For Child Participants
- Previous enrollment in PROBE, BASIC, LOGIC, or MITOHEP
- Exited from one of the aforementioned studies.
- Consent for DNA sample collection obtained during enrollment during enrollment to one of the aforementioned studies but sample not previously collected.
- Still followed at the clinical site.
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For Biological Parent Participants
- Biological parents of previously consented child participant without collection of a parental DNA biospecimen.
- Child still followed at the clinical site.
Exclusion Criteria:
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For Child Participants
- Participant is deceased
- Participant exited from prior study due to violating eligibility criteria
- Participant cannot be contacted
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For Biological Parent Participants
- Non-biological parent
- Child DNA was not previously collected and will not be collected in this study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05272319
Contacts
| Contact: Terri Howell | 734-369-9683 | thowell@arborresearch.org |
Locations
| United States, California | |
| Children's Hospital of Los Angeles | Not yet recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Catherine Goodhue, CPNP 323-361-4566 cgoodhue@chla.usc.edu | |
| Principal Investigator: Kasper Wang, MD | |
| UCSF Benioff Children's Hospital | Not yet recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Camille Langlois 415-476-1756 langloisc@peds.ucsf.edu | |
| Contact: Joanna Curry (415) 476-1756 joanna.curry@ucsf.edu | |
| Principal Investigator: Phil Rosenthal, MD | |
| United States, Colorado | |
| Children's Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Rodolfo Hernandez 720-777-1294 rodolfo.hernandez@childrenscolorado.org | |
| Principal Investigator: Ron Sokol | |
| United States, Georgia | |
| Children's Healthcare of Atlanta | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Katelynn Harris 404-785-0421 katelynn.harris@choa.org | |
| Principal Investigator: Saul Karpen | |
| United States, Illinois | |
| Lurie Children's Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Sue Kelly, RN 312-227-3523 skelly@luriechildrens.org | |
| Contact: Mary Riordan (312) 227-4558 mriordan@luriechildrens.org | |
| Principal Investigator: Estella Alonso, MD | |
| United States, Indiana | |
| Riley Hospital for Children | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Ann Klipsch 317-274-9605 aeye@iupui.edu | |
| Principal Investigator: Jean Molleston, MD | |
| United States, Ohio | |
| Cincinnati Children's Hospital | Not yet recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Jennifer Hawkins 513-636-7818 Jennifer.Hawkins@cchmc.org | |
| Contact: Erin Chapman (513) 517-7220 erin.chapman@cchmc.org | |
| Principal Investigator: Jorge Bezerra, MD | |
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Motolani Shenbanjo 267-426-8613 shenbanjom@email.chop.edu | |
| Contact: Katherine Cambareri (267) 426-8412 CAMBARERIK@EMAIL.CHOP.EDU | |
| Principal Investigator: Kathleen Loomes, MD | |
| UPMC Children's Hospital of Pittsburgh | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Christina Henry 412-692-3905 henryc8@upmc.edu | |
| Principal Investigator: Simon Horslen, MD | |
| United States, Texas | |
| Texas Children's Liver Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Laurel Cavallo 832-822-1053 Laurel.Cavallo@bcm.edu | |
| Sub-Investigator: Benjamin Shneider, MD | |
| United States, Utah | |
| University of Utah | Not yet recruiting |
| Salt Lake City, Utah, United States, 84113 | |
| Contact: Ann Rutherford 801-585-9495 ann.rutherford@hsc.utah.edu | |
| Principal Investigator: Steve Guthery | |
| United States, Washington | |
| Seattle Children's Hospital | Not yet recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Melissa Young 206-987-1037 melissa.young@seattlechildrens.org | |
| Contact: Kara Cooper (206) 987-4636 kara.cooper@seattlechildrens.org | |
| Principal Investigator: Evelyn Hsu, MD | |
| Canada, Ontario | |
| The Hospital for Sick Children | Not yet recruiting |
| Toronto, Ontario, Canada, M5G 1XG | |
| Contact: Deepika Sharma (416) 813-7654 x201594 deepika.sharma@sickkids.ca | |
| Contact: Ramisha Chowdhury (416) 813-7654 x201594 ramisha.chowdhury@sickkids.ca | |
| Principal Investigator: Binita Kamath, MD | |
Sponsors and Collaborators
Arbor Research Collaborative for Health
| Responsible Party: | Arbor Research Collaborative for Health |
| ClinicalTrials.gov Identifier: | NCT05272319 |
| Other Study ID Numbers: |
Genetic Collection - ChiLDReN |
| First Posted: | March 9, 2022 Key Record Dates |
| Last Update Posted: | April 22, 2022 |
| Last Verified: | March 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Liver Diseases Digestive System Diseases |