Clinical trial · Observational
A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: \- An important new area of brain tumor research is the development of tumor and brain stem cell lines. Successful growth of these cell lines requires obtaining large volumes of fresh tumor and brain tissue, which is best accomplished by harvesting whole brains from recently deceased patients. These cell lines will help researchers understand how these tumors develop and will also help identify new targets for treatment. Researchers are interested in conducting a pilot study of planned inpatient hospice care with timely brain tumor tissue harvest at the time of death. Objectives: * To provide high-quality end of life inpatient hospice care for patients with untreatable brain tumors. * To procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes. Eligibility: * Individuals at least 18 years of age who have an untreatable primary brain or central nervous system tumor, are able to give informed consent (either their own or through a designated power of attorney), and have agreed to a Do Not Resuscitate order and Consent for Autopsy as part of the end-of-life care plan. * HIV-positive individuals or those suspected of having infectious cerebritis are not eligible because of the potential for contamination of brain tissue. Design: * Participants will be enrolled in inpatient hospice admission to the National Institutes of Health Clinical Center either from home or from an outside hospital once a study investigator estimates an expected survival of less than 2 weeks. * Participants will receive palliative care at the Clinical Center. Care will be tailored to each participant depending on the information provided in the individual's end-of-life care plan. * Supportive medications such as antiseizure medications and pain relievers will be administered as appropriate. * At the time of death, researchers will follow standard procedures for notifying next of kin and will collect brain tissue and tumor samples from the deceased. * Following tissue collection, the deceased will be released for autopsy and funeral procedures.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ependymomas | Ependymoma | ALIAS | 0.90 |
| Gliomas | Glioma | ALIAS | 0.90 |
| PCNSL (Primary CNS Lymphoma) | Primary Central Nervous System Lymphoma | ALIAS | 0.85 |
| Pineal Tumors | Pineal Region Neoplasm | ALIAS | 0.90 |
| PNET | Primitive Neuroectodermal Tumor | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors.
Secondary outcomes (1)
- measure
- Procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
* INCLUSION CRITERIA: 1. Patients with primary brain tumors including glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), low grade astrocytoma, low grade oligoastrocytoma, low grade oligodendroglioma, astrocytoma NOS (not otherwise specified), radiographically diagnosed brain stem gliomas, primitive neuroectodermal tumors (PNETs, including medulloblastomas, supratentorial PNET), pineal tumors, glioneuronal tumors, ependymomas and primary central nervous system lymphomas. 2. All patients or their LAR (Legally Authorized Individual) (if the patient is deemed by the treating physician to be impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study. 3. Patients or their LAR and their legal next of kin must agree to a Do Not Resuscitate order and Consent for Autopsy as part of the end-of-life care plan. 4. Patients must be greater than or equal to 18 years old, and with a life expectancy \< two weeks. 5. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. EXCLUSION CRITERIA: 1. Known to be pregnant (known positive pregnancy test although such testing is not a requirement for enrollment). 2. HIV-positive patients or those suspected of infectious cerebritis/abscess are ineligible because of the potential for contamination of brain tissue.
References
Publications (3)
- BACKGROUNDDeschavanne PJ, Fertil B. A review of human cell radiosensitivity in vitro. Int J Radiat Oncol Biol Phys. 1996 Jan 1;34(1):251-66. doi: 10.1016/0360-3016(95)02029-2. PMID 12118559
- BACKGROUNDHecht BK, Turc-Carel C, Chatel M, Grellier P, Gioanni J, Attias R, Gaudray P, Hecht F. Cytogenetics of malignant gliomas: I. The autosomes with reference to rearrangements. Cancer Genet Cytogenet. 1995 Oct 1;84(1):1-8. doi: 10.1016/0165-4608(95)00091-7. PMID 7497435
- BACKGROUNDPardal R, Clarke MF, Morrison SJ. Applying the principles of stem-cell biology to cancer. Nat Rev Cancer. 2003 Dec;3(12):895-902. doi: 10.1038/nrc1232. No abstract available. PMID 14737120