Rapid Autopsy and Procurement of Cancer Tissue

NCT01851395 | Terminated

• 2 other identifiers: 13013113-C-0131
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- 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 lung cancer, ovarian cancer, bladder cancer, or patients who have been treated with adoptive cell therapy. \<TAB\> Objectives: \- To collect cancer tissue biopsy samples as soon as possible after death. Eligibility: \- 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. 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.

Conditions

Mesothelioma; Lung Cancers; Genitourinary Cancers; Thymus Tumors; Adoptive Cellular Therapy

Keywords

Palliative; Tumor Heterogeneity; Genomic and Proteomic Alterations; Deep Sequencing and Global Analysis; Clonal Evolution; Natural History

Outcome Measures

Primary Outcomes (1)

• Tumor heterogeneity

  Both intratumor and between paired primary and metastatic site, using integrated genomic and proteomic analysis.

  Death

Secondary Outcomes (1)

• Genetic alterations

  completion of study

Study Arms (5)

1/Thoracic

Patients with histologically or cytologically confirmed metastatic NSCLC, SCLC, EPCC, pNET, thymic epithelial tumor (thymoma, thymic carcinoma) or mesothelioma

2/Genitourinary

Patients with genitourinary malignancies

3/ACT

Patients treated with an adoptive cellular therapy

4/Ovarian

Patients with ovarian cancer

5/Epithelial

Patients with breast, colorectal, pancreatic, stomach or biliary cancer.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected primarily from the CC medical oncology clinic setting.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Thymus Neoplasms; Mesothelioma; Urogenital Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anish Thomas, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: December 30, 2013
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)