Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells

Pediatric Cancer Clinical Trial

Official title:

Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05120518
• Other study ID #: 2019-2982
• Status: Recruiting
• Start date: August 14, 2019
• Est. completion date: August 14, 2029

Study information

• Verified date: November 2021
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Angela Waanders, MD
• Phone: 312-227-4090
• Email: awaanders[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 14, 2029
• Est. primary completion date: August 14, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Pediatric Cancer

Intervention

Other:
• Collection of post mortem tissue donation
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.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Meeting Minutes: Enhancing Biobanking for Childhood Cancers, NCI, May 13, 2019

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procurement of pediatric cancer and non-cancer tumor tissue during autopsy with signed consent	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

External Links

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