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Spots Global Cancer Trial Database for A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes

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Trial Identification

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

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

Study ID: NCT01251913

Interventions

Study Description

Brief 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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Contact Details

Name: Katherine E Warren, M.D.

Affiliation: National Cancer Institute (NCI)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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