Rapid Autopsy and Procurement of Cancer Tissue
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|ClinicalTrials.gov Identifier: NCT01851395|
Recruitment Status : Recruiting
First Posted : May 10, 2013
Last Update Posted : August 27, 2020
- Individuals with cancer of the lung, chest cavity or bladder, as well as patients who have been treated with adoptive cell therapy unfortunately commonly succumb to their disease. Some agree to donate their bodies to cancer research that may help the medical community better understand these diseases. Studies of cancer tumor tissue obtained soon after death may be used to answer questions about the origins, progression, and treatment of cancer. Researchers want to conduct a study that involves planned collection of cancer tumor tissue shortly after death. To do so, they will arrange to provide inpatient hospice care for people with non-small cell lung cancer, bladder cancer or patients who have been treated with adoptive cell therapy.
- To collect cancer tissue biopsy samples as soon as possible after death.
- Individuals who have cancer of the lung, chest cavity or bladder, or those who have been treated with adoptive cell therapy and are planning to receive end-of-life hospice care are eligible to participate.
- Participants will agree to receive inpatient hospice care at the National Institutes of Health Clinical Center. Full details on end-of-life care preference will be acknowledged.
- An autopsy will be performed at the clinical center within 3 hours of death. Tumor tissue will be collected from the primary site of cancer and from any areas of the body to which the cancer has spread.
- Participants will not receive further cancer treatments as part of this study. This is a tissue collection study only.
|Condition or disease|
|Thymus Tumors Adoptive Cellular Therapy Mesothelioma Genitourinary Cancers Lung Cancers|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||A Pilot Study of Inpatient Hospice With Procurement of Tissue on Expiration in Thoracic Malignancies|
|Actual Study Start Date :||December 30, 2013|
|Estimated Primary Completion Date :||March 31, 2026|
|Estimated Study Completion Date :||March 31, 2027|
Patients with histologically or cytologically confirmed metastatic NSCLC, SCLC, EPCC, pNET, thymic epithelial tumor (thymoma, thymic carcinoma) or mesothelioma.
Patients with genitourinary malignancies
Patients treated with an adoptive cellular therapy
- Procurement of primary and metastatic tissue of thoracic malignancies shortly after death in order to investigate tumor heterogeneity [ Time Frame: Death ]Both intratumor and between paired primary and metastatic site, using integrated genomic and proteomic analysis.
- Genetic alterations [ Time Frame: completion of study ]To compare genetic alterations of autopsied tissue with archival tissue from primary and metastatic sites when available, to evaluate heterogeneity between primary and metastatic sites and at two different times during tumor evolution.Compare genomic alterations in tumor tissue with those identified in isolated circulating tumor cells from blood obtained during the short hospital stay before death.
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): NCT01851395
|Contact: Linda C Sciuto, R.N.||(240) email@example.com|
|Contact: Anish Thomas, M.D.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Anish Thomas, M.D.||National Cancer Institute (NCI)|