Rapid Autopsy and Procurement of Cancer Tissue
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/23/2018 |
| Start Date: | December 30, 2013 |
| End Date: | March 31, 2025 |
| Contact: | Elizabeth Q Akoth |
| Email: | elizabeth.akoth@nih.gov |
| Phone: | (240) 858-3154 |
Inpatient Hospice With Procurement of Tissue on Expiration in Thoracic Malignancies, Bladder Cancer, and Patients Treated With an Adoptive Cellular Therapy
Background:
- 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.
Objectives:
- To collect cancer tissue biopsy samples as soon as possible after death.
Eligibility:
- 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.
Design:
- 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.
- 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.
Objectives:
- To collect cancer tissue biopsy samples as soon as possible after death.
Eligibility:
- 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.
Design:
- 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.
Background:
- Despite being the leading cause of cancer-related death worldwide, there is only limited
knowledge of tumor heterogeneity in lung cancer. There is also limited knowledge of
tumor heterogeneity of other less common thoracic malignancies, such as thymic
epithelial tumors and mesothelioma. The extent and causes of intra-tumor and
inter-metastatic heterogeneity in thoracic malignancies and how they compare to other
tumor types is of utmost importance in managing lung cancer. Newer approaches of
treating malignancies by targeting immune cells or tumor microenvironment are emerging.
Adoptive cellular therapy (ACT) is one such approach. How this therapy affects
individual metastatic sites and specific clones of tumor cells is poorly understood.
- Little is known about the clonal architecture of advanced, heavily-treated urothelial
carcinoma or the dynamics that lead to metastasis and chemotherapy and immunotherapy
resistance. Urothelial carcinomas have a high somatic mutation rate (median 5.5 per
megabase) similar to that of non-small cell lung cancer and melanoma. Urothelial
carcinoma tumors are extremely heterogenous and the extent of heterogeneity post
treatment is an important area of research that should be further explored.
Understanding the genetic and clonal evolution of urothelial carcinoma tumors will
eventually help guide management of treatment-resistant metastatic tumors. Comprehensive
tissue procurement by rapid autopsy will serve as a valuable mechanism to further
characterize aggressive treatment-resistant, metastatic urothelial carcinomas and other
rare genitourinary histologies.
- Tumor heterogeneity can be evaluated in a comprehensive manner by deep sequencing and
globally analyzing genomic and proteomic alterations of simultaneous core biopsies from
several areas of the primary tumor and metastases. These analyses correlated with
clinical outcomes can further the evaluation of tumor heterogeneity. However, such
studies are not feasible in a clinical setting.
- Tissue procurement by rapid autopsies provides an effective way for such an
investigation.
Hypothesis:
- Clonal evolution and selection of tumor cells can be assessed by examining genomic and
proteomic alterations of tumor samples obtained from multiple sites of primary and metastatic
sites.
Objectives:
- Procure primary and metastatic tissue of thoracic malignancies, bladder cancer and from
patients treated with an ACT shortly after death, to investigate tumor heterogeneity and
immune microenvironment intratumorally, between paired primary and metastatic sites, and
among inter-metastatic tumors using integrated genomic and proteomic analysis.
Eligibility:
- Adult patients with metastatic non-small cell lung cancer (NSCLC), small cell lung cancer
(SCLC), extrapulmonary small cell cancer (ESCC), pulmonary neuroendocrine tumor (pNET),
thymic epithelial tumor, mesothelioma, bladder cancer (including urothelial carcinoma and
other rare bladder or kidney histology) and patients treated with an ACT, with no expected
chance of cure and an expected survival of less than 3 months.
Design:
- Forty patients with NSCLC; 12 each with SCLC, thymic epithelial tumors, and
mesothelioma; 6 each of ESCC and pNET; 20 patients with bladder cancer; and 20 patients
treated with an ACT will be autopsied in this study.
- Patients will be admitted for inpatient hospice when an investigator evaluates that
death is clinically imminent.
- Upon expiration, rapid autopsy will be performed and tissue will be obtained from the
primary tumor site, if identifiable, and multiple metastatic sites to assess tumor
heterogeneity and immune microenvironment using deep sequencing and global genomic and
proteomic analyses.
- Archival tissue from patients, if available, will be used to evaluate these changes from
several stages of tumor progression.
- Despite being the leading cause of cancer-related death worldwide, there is only limited
knowledge of tumor heterogeneity in lung cancer. There is also limited knowledge of
tumor heterogeneity of other less common thoracic malignancies, such as thymic
epithelial tumors and mesothelioma. The extent and causes of intra-tumor and
inter-metastatic heterogeneity in thoracic malignancies and how they compare to other
tumor types is of utmost importance in managing lung cancer. Newer approaches of
treating malignancies by targeting immune cells or tumor microenvironment are emerging.
Adoptive cellular therapy (ACT) is one such approach. How this therapy affects
individual metastatic sites and specific clones of tumor cells is poorly understood.
- Little is known about the clonal architecture of advanced, heavily-treated urothelial
carcinoma or the dynamics that lead to metastasis and chemotherapy and immunotherapy
resistance. Urothelial carcinomas have a high somatic mutation rate (median 5.5 per
megabase) similar to that of non-small cell lung cancer and melanoma. Urothelial
carcinoma tumors are extremely heterogenous and the extent of heterogeneity post
treatment is an important area of research that should be further explored.
Understanding the genetic and clonal evolution of urothelial carcinoma tumors will
eventually help guide management of treatment-resistant metastatic tumors. Comprehensive
tissue procurement by rapid autopsy will serve as a valuable mechanism to further
characterize aggressive treatment-resistant, metastatic urothelial carcinomas and other
rare genitourinary histologies.
- Tumor heterogeneity can be evaluated in a comprehensive manner by deep sequencing and
globally analyzing genomic and proteomic alterations of simultaneous core biopsies from
several areas of the primary tumor and metastases. These analyses correlated with
clinical outcomes can further the evaluation of tumor heterogeneity. However, such
studies are not feasible in a clinical setting.
- Tissue procurement by rapid autopsies provides an effective way for such an
investigation.
Hypothesis:
- Clonal evolution and selection of tumor cells can be assessed by examining genomic and
proteomic alterations of tumor samples obtained from multiple sites of primary and metastatic
sites.
Objectives:
- Procure primary and metastatic tissue of thoracic malignancies, bladder cancer and from
patients treated with an ACT shortly after death, to investigate tumor heterogeneity and
immune microenvironment intratumorally, between paired primary and metastatic sites, and
among inter-metastatic tumors using integrated genomic and proteomic analysis.
Eligibility:
- Adult patients with metastatic non-small cell lung cancer (NSCLC), small cell lung cancer
(SCLC), extrapulmonary small cell cancer (ESCC), pulmonary neuroendocrine tumor (pNET),
thymic epithelial tumor, mesothelioma, bladder cancer (including urothelial carcinoma and
other rare bladder or kidney histology) and patients treated with an ACT, with no expected
chance of cure and an expected survival of less than 3 months.
Design:
- Forty patients with NSCLC; 12 each with SCLC, thymic epithelial tumors, and
mesothelioma; 6 each of ESCC and pNET; 20 patients with bladder cancer; and 20 patients
treated with an ACT will be autopsied in this study.
- Patients will be admitted for inpatient hospice when an investigator evaluates that
death is clinically imminent.
- Upon expiration, rapid autopsy will be performed and tissue will be obtained from the
primary tumor site, if identifiable, and multiple metastatic sites to assess tumor
heterogeneity and immune microenvironment using deep sequencing and global genomic and
proteomic analyses.
- Archival tissue from patients, if available, will be used to evaluate these changes from
several stages of tumor progression.
- INCLUSION CRITERIA:
- Patients must have histologically or cytologically confirmed metastatic NSCLC, SCLC,
EPCC, pNET, thymic epithelial tumor (thymoma, thymic carcinoma) or mesothelioma
confirmed by the NCI Laboratory of Pathology. Patients with bladder cancer (including
urothelial carcinoma and other rare bladder or kidney histology) and malignancies
previously treated with an ACT are also eligible.
- Age >= 18 years.
- Incurable disease or terminal diagnosis
- Patients must sign an informed consent indicating that they are aware of the
investigational nature of this study.
- Patients must provide valid written designation of an assigned Durable Power of
Attorney. If one is not available, an LAR must be assigned.
- Patients and their legal next of kin must agree to a Do Not Resuscitate (DNR) order
and agree to Consent for Autopsy as part of the end-of-life care plan.
- 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:
- Women known to be pregnant (known positive pregnancy test, although such testing is
not required for enrollment) are excluded.
- Known HIV-positive patients will be excluded (although HIV testing is not required for
enrollment) because of the potential for contamination of tissue.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 888-624-1937
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