Rapid Autopsy and Procurement of Non-Small Cell Lung Cancer Tissue

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01851395
First received: May 8, 2013
Last updated: June 6, 2014
Last verified: February 2014
  Purpose

Background:

- People with lung cancers 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 lung cancer tumor tissue obtained soon after death may be used to answer questions about the origins, progression, and treatment of lung cancer. Researchers want to conduct a study that involves planned collection of lung 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.

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Objectives:

- To collect lung cancer tissue biopsy samples as soon as possible after death.

Eligibility:

- Individuals who have non-small cell lung cancer and are planning to receive end-of-life hospice care.

Design:

  • Participants will agree to receive inpatient hospice care at the National Institutes of Health Clinical Center. Full details on end-of-life instructions will be noted.
  • 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
Non- Small Cell Lung Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pilot Study of Inpatient Hospice With Procurement of Tissue on Expiration in Thoracic Malignancies

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Tumor tissue from multiple anatomical sites obtained [ Time Frame: within 3 hours after death ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: April 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  • Tumor heterogeneity can be evaluated in a comprehensive manner by deep sequencing and global analysis of genomic and proteomic alterations of simultaneous core biopsies from several areas of the primary tumor and metastases and correlation with clinical outcome. 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 shortly after death in order to investigate tumor heterogeneity- both intratumor and between paired primary and metastatic site, 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 (ESCCs), pulmonary neuroendocrine tumors (PNETs), thymic epithelial tumors, and mesothelioma with life expectancy less than or equal to 3 months

Design

- Twelve patients each of NSCLC, SCLC, thymic epithelial tumors, and mesothelioma,

and six each of ESCCs and pNETs will be autopsied in this pilot study.

  • Patients will be admitted for inpatient hospice when an investigator estimates a survival of less than 2 weeks.
  • Upon expiration, rapid autopsy will be performed and tissue obtained from primary tumor site if still identifiable, and multiple metastatic sites to assess tumor heterogeneity 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA

2.1.1.1 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

2.1.1.2 Age greater than 18 years.

2.1.1.3 Life expectancy less than or equal to 3 months.

2.1.1.4 Patients or their previously designated Durable Power of Attorney (DPA) (if the patient is deemed by the treating physician to be impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study.

2.1.1.5 Patients or their previously designated DPA 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.

2.1.1.6 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

2.1.2.1 Women known to be pregnant (known positive pregnancy test, although such testing is not required for enrollment) are excluded.

2.1.2.2 Known HIV-positive patients will be excluded (although HIV testing is not required for enrollment) because of the potential for contamination of tissue.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851395

Contacts
Contact: Susan A Perry, R.N. Not Listed perrys@mial.nih.gov
Contact: Udayan Guha, M.D. (301) 402-3524 udayan.guha@nih.gov

Locations
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
Investigators
Principal Investigator: Udayan Guha, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01851395     History of Changes
Other Study ID Numbers: 130131, 13-C-0131
Study First Received: May 8, 2013
Last Updated: June 6, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Palliative
Tumor Heterogeneity
Genomic and Proteomic Alterations
Deep Sequencing and Global Analysis
Clonal Evolution

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014