Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05120518
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Angela Waanders, Ann & Robert H Lurie Children's Hospital of Chicago

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Pediatric Cancer Other: Collection of post mortem tissue donation

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : August 14, 2029
Estimated Study Completion Date : August 14, 2029
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05120518


Contacts
Layout table for location contacts
Contact: Angela Waanders, MD 312-227-4090 awaanders@luriechildrens.org
Contact: Melissa Williams, BA 312-227-3893 mjwilliams@luriechildrens.org

Locations
Layout table for location information
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Angela Waanders, MD    312-227-4090    awaanders@luriechildrens.org   
Contact: Melissa Williams, BA    312-227-3893    mjwilliams@luriechildrens.org   
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Layout table for investigator information
Principal Investigator: Angela Waanders, MD Ann & Robert H Lurie Children's Hospital of Chicago
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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

Layout table for additonal information
Responsible Party: Angela Waanders, Principle Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT05120518    
Other Study ID Numbers: 2019-2982
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To provide samples and PHI to CBTN. Samples and data will be de-identified prior to placement in the CBTN Biorepository.
Supporting Materials: Study Protocol
Informed Consent Form (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms