- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05120518
Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (PDOX) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, CBTN, DIPG Registry, COG).
This model system will then be subjected to 1) comprehensive histopathological and molecular characterizations during serial in vivo sub-transplantations; 2) cryopreserved for long term preservation of tumorigenicity; and 3) used for future biological studies and preclinical drug testing.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Angela Waanders, MD
- Phone Number: 312-227-4090
- Email: awaanders@luriechildrens.org
Study Contact Backup
- Name: Melissa Williams, BA
- Phone Number: 312-227-3893
- Email: mjwilliams@luriechildrens.org
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Ann & Robert H. Lurie Children's Hospital of Chicago
-
Contact:
- Angela Waanders, MD
- Phone Number: 312-227-4090
- Email: awaanders@luriechildrens.org
-
Contact:
- Melissa Williams, BA
- Phone Number: 312-227-3893
- Email: mjwilliams@luriechildrens.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)
- Signed consent for post mortem tissue donation and autopsy
Exclusion Criteria:
- Signed consent for post mortem tissue donation and autopsy not obtained
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pediatric patients with cancer and non-cancer tumor types
Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology and stem cell)
|
Collection of post mortem tissue from pediatric participants with cancer and non-cancer tumor types from whom post mortem tissue donation and autopsy consent is obtained.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procurement of pediatric cancer and non-cancer tumor tissue during autopsy with signed consent
Time Frame: Up to 5 years from procurement
|
Procurement of pediatric cancer and non-cancer tumor tissue during autopsy with signed consent.
Tissue will be collected through a research tissue collection autopsy of the original tumor and other sites that are appropriate.
Samples of both tumor and normal cells will be collected in addition to body fluids such as cerebrospinal fluid (CSF), blood, bone marrow, and skin biopsies for genomic testing.
|
Up to 5 years from procurement
|
Collaborators and Investigators
Investigators
- Principal Investigator: Angela Waanders, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Publications and helpful links
General Publications
- Baker JN, Windham JA, Hinds PS, Gattuso JS, Mandrell B, Gajjar P, West NK, Hammarback T, Broniscer A. Bereaved parents' intentions and suggestions about research autopsies in children with lethal brain tumors. J Pediatr. 2013 Aug;163(2):581-6. doi: 10.1016/j.jpeds.2013.01.015. Epub 2013 Feb 19.
- Broniscer A, Baker JN, Baker SJ, Chi SN, Geyer JR, Morris EB, Gajjar A. Prospective collection of tissue samples at autopsy in children with diffuse intrinsic pontine glioma. Cancer. 2010 Oct 1;116(19):4632-7. doi: 10.1002/cncr.25405.
- Wiener L, Sweeney C, Baird K, Merchant MS, Warren KE, Corner GW, Roberts KE, Lichtenthal WG. What do parents want to know when considering autopsy for their child with cancer? J Pediatr Hematol Oncol. 2014 Aug;36(6):464-70. doi: 10.1097/MPH.0000000000000078.
- Alabran JL, Hooper JE, Hill M, Smith SE, Spady KK, Davis LE, Peterson LS, Malempati S, Ryan CW, Acosta R, Spunt SL, Keller C. Overcoming autopsy barriers in pediatric cancer research. Pediatr Blood Cancer. 2013 Feb;60(2):204-9. doi: 10.1002/pbc.24320. Epub 2012 Sep 26.
- Meeting Minutes: Enhancing Biobanking for Childhood Cancers, NCI, May 13, 2019
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-2982
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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