A Pilot Study of Rapid Autopsy and Procurement of Tissue in Non-Small Cell Lung Cancer Patients to Investigate Tumor Heterogeneity
18 Years
N/A
Both
Non- Small Cell Lung Cancer
Trial Information
A Pilot Study of Rapid Autopsy and Procurement of Tissue in Non-Small Cell Lung Cancer Patients to Investigate Tumor Heterogeneity
Background
- Despite being the leading cause of cancer-related death worldwide, there is only
limited knowledge of tumor heterogeneity in NSCLC.
- 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 NSCLC and metastatic tissue 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 NSCLC with life expectancy less than or equal to 3 months
Design
- Ten patients 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.
Inclusion Criteria
- INCLUSION CRITERIA
2.1.1.1 Patients must have histologically or cytologically confirmed metastatic NSCLC
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.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
Tumor tissue from multiple anatomical sites obtained
Outcome Time Frame:
within 3 hours after death
Safety Issue:
No
Principal Investigator
Udayan Guha, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
130131
NCT ID:
NCT01851395
Start Date:
April 2013
Completion Date:
May 2014
Related Keywords:
- Non- Small Cell Lung Cancer
- Palliative
- Tumor Heterogeneity
- Genomic and Proteomic Alterations
- Deep Sequencing and Global Analysis
- Clonal Evolution
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
