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

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ClinicalTrials.gov Identifier: NCT01851395
Recruitment Status : Recruiting
First Posted : May 10, 2013
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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 or disease
Thymus Tumors Mesothelioma Non- Small Cell Lung Cancer Small Cell Lung Cancer

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inpatient Hospice With Procurement of Tissue on Expiration in Thoracic Malignancies, Bladder Cancer, and Patients Treated With an Adoptive Cellular Therapy
Actual Study Start Date : December 30, 2013
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hospice Care

Group/Cohort
Thoracic malignancies
Patients with histologically or cytologically confirmed metastatic NSCLC, SCLC, EPCC, pNET, thymic epithelial tumor (thymoma, thymic carcinoma) or mesothelioma.
Genitourinary malignancies
Patients with genitourinary malignancies
ACT
Patients treated with an adoptive cellular therapy



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (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.
Criteria
  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01851395


Contacts
Contact: Elizabeth Q Akoth (240) 858-3154 elizabeth.akoth@nih.gov
Contact: Udayan Guha, M.D. (240) 760-6115 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Udayan Guha, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01851395     History of Changes
Other Study ID Numbers: 130131
13-C-0131
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 19, 2018

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Mesothelioma
Thymus Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lymphatic Diseases