ClinicalTrials.gg
TerminatedNCT01251913Updated Dec 3, 2019

A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes

An observational study in Ependymomas, Gliomas and PNET, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.
Read the detailed description

BACKGROUND:

  • Patients treated by the Neuro-Oncology Branch (NOB) for their brain tumors unfortunately and commonly succumb to their disease. They and their loved ones often seek a way of adding meaning and utility to their death by agreeing to donate brain tumor tissue for laboratory research that may serve the medical community, and ultimately other patients, through better understanding of these rare diseases. Important new avenues of brain tumor research includes the molecular characterization of tumor tissue, and the development of tumor and neural stem cell lines. Successful growth of these cell lines requires acquisition of large volumes of fresh tumor and brain tissue that can best be accomplished by harvesting whole brains from recently deceased patients. In an effort to provide high quality end of life care, with the additional intent of facilitating efficient donation of brain tumor tissue at the time of death, we are conducting a pilot study of planned inpatient hospice care incorporating timely brain tumor tissue procurement at the time of expiration.

OBJECTIVES:

  • Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors.
  • 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:

  • Adult patients with primary brain tumors.

DESIGN:

  • This is a pilot study to assess feasibility of procuring viable brain and tumor tissue proximal to the time of death. Target accrual is 10 patients for brain harvest.
02

Conditions studied

  • Ependymomas
  • Gliomas
  • PNET
  • Pineal Tumors
  • PCNSL (Primary CNS Lymphoma)

Keywords

  • Tissue Harvest
  • Hospice
  • Autopsy
  • Crainiotomy
  • Brain Tumor
  • Glioma
  • Astrocytoma
03

In context

Ependymoma

224 studies on the registry are indexed under Ependymoma; 35 are open to participants now.

This study's enrollment of 7 is below the median of 100 across 25 observational studies indexed under Ependymoma.

Browse Ependymoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

    1. 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 is questionable) must sign an informed consent indicating that they are aware of the nature of this study.
    2. 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.
    3. Patients must be greater than or equal to 18 years old, and with a \< two weeks.
    4. 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

EXCLUSION CRITERIA:

  1. Known to be pregnant (known positive pregnancy test although such testing is not a requirement for enrollment).
  2. -positive patients or those suspected of infectious cerebritis/abscess are ineligible because of the potential for contamination of brain tissue.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (actual)
06

What researchers measure

Primary outcomes

  1. Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors.

Secondary outcomes

  1. Procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.

07

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Deschavanne 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. PubMed 12118559 ↗
  • Hecht 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. PubMed 7497435 ↗
  • Pardal 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. PubMed 14737120 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2010 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2010
First posted
Dec 2, 2010
Start
Nov 12, 2010
Completion
Apr 29, 2015
Last update
Dec 3, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01251913
Responsible party
Sponsor
First posted
Dec 2, 2010
Start date
Nov 12, 2010
Completion
Apr 29, 2015
Last update
Dec 3, 2019

Study contacts

Katherine E Warren, M.D.
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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