Pediatric CancerNCT05120518
Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells
An observational study of Pediatric Cancer, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Collection of post mortem tissue donation
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 14 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)
Who may be able to join
- Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)
- Signed consent for post mortem tissue donation and autopsy
Who cannot join
- Signed consent for post mortem tissue donation and autopsy not obtained
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Angela Waanders, MD, 312-227-4090, awaanders@luriechildrens.org
Melissa Williams, BA, 312-227-3893, mjwilliams@luriechildrens.org
About this study
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).
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Collection of post mortem tissue donation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of post mortem tissue donationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Collection of post mortem tissue donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years from procurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start14 Aug 2019
- Primary completion14 Aug 2029 (estimated)
- Study completion14 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Waanders, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Angela Waanders, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120518
- Sponsor's protocol ID
- 2019-2982
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To provide samples and PHI to CBTN. Samples and data will be de-identified prior to placement in the CBTN Biorepository.
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.
PubMed 23433673Broniscer 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.
PubMed 20589749Wiener 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.
PubMed 24309611Alabran 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.
PubMed 23015377Meeting Minutes: Enhancing Biobanking for Childhood Cancers, NCI, May 13, 2019
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells
- ClinicalTrials.gov ID
- NCT05120518
- Acronym / sponsor ID
- 2019-2982
- Conditions
- Pediatric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 14 Aug 2029 (estimated)
- Study completion
- 14 Aug 2029 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with cancer and non-cancer tumor types | – | Other: Collection of post mortem tissue donationPediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology and stem cell) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)
Key inclusion criteria (2 listed)
- Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)
- Signed consent for post mortem tissue donation and autopsy
Key exclusion criteria (1 listed)
- Signed consent for post mortem tissue donation and autopsy not obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of post mortem tissue donationCollection 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. | Other | Pediatric patients with cancer and non-cancer tumor types |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 23433673Baker 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.
- Background: PubMed 20589749Broniscer 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.
- Background: PubMed 24309611Wiener 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.
- Background: PubMed 23015377Alabran 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.
- BackgroundMeeting Minutes: Enhancing Biobanking for Childhood Cancers, NCI, May 13, 2019
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. To provide samples and PHI to CBTN. Samples and data will be de-identified prior to placement in the CBTN Biorepository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Waanders, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Waanders, MD (312-227-4090, awaanders@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procurement of pediatric cancer and non-cancer tumor tissue during autopsy with signed consent (time frame: Up to 5 years from procurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120518, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.