NCT05120518

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
40mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Aug 2019Aug 2029

Study Start

First participant enrolled

August 14, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2029

Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

10 years

First QC Date

November 3, 2021

Last Update Submit

November 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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)

Other: Collection of post mortem tissue donation

Interventions

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.

Pediatric patients with cancer and non-cancer tumor types

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)

You may qualify if:

  • Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)
  • Signed consent for post mortem tissue donation and autopsy

You may not qualify if:

  • Signed consent for post mortem tissue donation and autopsy not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 23433673BACKGROUND
  • 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.

    PMID: 20589749BACKGROUND
  • 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.

    PMID: 24309611BACKGROUND
  • 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.

    PMID: 23015377BACKGROUND
  • Meeting Minutes: Enhancing Biobanking for Childhood Cancers, NCI, May 13, 2019

    BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Tissue will be collected through a research tissue collection autopsy of the original tumor and other sites that are appropriate. Both tumor and normal cells will be collected during autopsy in addition to body fluids such cerebrospinal fluid (CSF), blood, bone marrow and skin biopsies for genomic testing. For brain tumor bio-specimens, through CBTN, we will store, analyze and share a large cohort of samples and within the repository protocol annotate and characterize using the latest genomic technologies. The information and materials collected will be used to support cross-disciplinary collaborations and coordinated research projects, focused on the molecular and cellular origins of children's tumors.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Angela Waanders, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 3, 2021

First Posted

November 15, 2021

Study Start

August 14, 2019

Primary Completion (Estimated)

August 14, 2029

Study Completion (Estimated)

August 14, 2029

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

To provide samples and PHI to CBTN. Samples and data will be de-identified prior to placement in the CBTN Biorepository.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Starting August 2019
Access Criteria
The IPD for this study will be stored in the CBTN Biorepository. Samples and data will be de-identified prior to placement in the CBTN Biorepository. Researchers who have been granted access to the CBTN Biorepository will have access to the IPD for this study.

Locations