Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Rapid Autopsy and Procurement of Cancer Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01851395
Recruitment Status : Recruiting
First Posted : May 10, 2013
Last Update Posted : June 28, 2022
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- Individuals with cancer of the lung, chest cavity, ovary, 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, ovarian 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, ovary, 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

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 205 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inpatient Hospice With Procurement of Tissue on Expiration in Thoracic Malignancies, Bladder Cancer, Ovarian Cancer, Epithelial Cancer and Patients Treated With an Adoptive Cellular Therapy
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
Patients with ovarian cancer
Patients with breast, colorectal, pancreatic, stomach or biliary cancer.

Primary Outcome Measures :
  1. Tumor heterogeneity [ Time Frame: Death ]
    Both intratumor and between paired primary and metastatic site, using integrated genomic and proteomic analysis.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected primarily from the CC medical oncology clinic setting.
  • 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), ovarian cancer, epithelial cancers (breast, colorectal, pancreatic, stomach and biliary cancers) and malignancies previously treated with an ACT are also eligible.
  • Age >= 18 years.
  • Incurable disease or terminal diagnosis with an expected survival of less than 3 months.
  • Patients or legally authorized representative (LAR) 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 (DPA). 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


  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01851395

Layout table for location contacts
Contact: Linda C Sciuto, R.N. (240) 760-6117
Contact: Anish Thomas, M.D. (240) 760-7343

Layout table for location information
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      
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Anish Thomas, M.D. National Cancer Institute (NCI)
Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI) Identifier: NCT01851395    
Other Study ID Numbers: 130131
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 13, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Tumor Heterogeneity
Genomic and Proteomic Alterations
Deep Sequencing and Global Analysis
Clonal Evolution
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Neoplasms by Site