Genome Sequencing of Human Cancer Tissues
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/2/2019 |
| Start Date: | January 2015 |
| End Date: | December 2020 |
| Contact: | Stuart S Winter, MD |
| Email: | swinter@salud.unm.edu |
The goal of this study is to develop a new, local system that will use special tests based on
patients' genetic makeup to better tailor cancer care at the University of New Mexico Cancer
Center.
The Food and Drug Administration has already approved over forty (40) drugs to treat cancer
patients based on specific genetic makeup, and more agents are in development that will
support this new approach to treatment, often referred to as "personalized medicine."
The goal of performing specific tests on patients' genetic material is to discover
tumor-specific, single nucleotide variations (SNVs) and other forms of genetic changes
(called epigenetic changes) that can be detected when comparing normal tissue and tumor
tissue. This can help guide cancer care decisions that may be more effective for patients.
These will be called clinically actionable findings, or CAF.
Additional health related findings may be made, not related to cancer but to other
conditions, diseases or syndromes. These are called secondary findings (SF). In this study
the investigators will also measure how often they find SF and will discuss their possible
impact on other aspects of patients' health. If patients want to know about these findings,
they will be discussed with a panel of experts including genetic counselors.
Finally, the investigators will compare how often CAF and SF differ from those identified in
nationwide samples.
patients' genetic makeup to better tailor cancer care at the University of New Mexico Cancer
Center.
The Food and Drug Administration has already approved over forty (40) drugs to treat cancer
patients based on specific genetic makeup, and more agents are in development that will
support this new approach to treatment, often referred to as "personalized medicine."
The goal of performing specific tests on patients' genetic material is to discover
tumor-specific, single nucleotide variations (SNVs) and other forms of genetic changes
(called epigenetic changes) that can be detected when comparing normal tissue and tumor
tissue. This can help guide cancer care decisions that may be more effective for patients.
These will be called clinically actionable findings, or CAF.
Additional health related findings may be made, not related to cancer but to other
conditions, diseases or syndromes. These are called secondary findings (SF). In this study
the investigators will also measure how often they find SF and will discuss their possible
impact on other aspects of patients' health. If patients want to know about these findings,
they will be discussed with a panel of experts including genetic counselors.
Finally, the investigators will compare how often CAF and SF differ from those identified in
nationwide samples.
For brevity, the investigators include the approaches of whole genome sequencing, whole exome
sequencing of just the protein-coding exons, enrichment and sequencing of methylated DNA and
RNA or transcriptome-sequencing under the broad category term, Whole Genome Sequencing (WGS).
The development of rapid and low cost next-generation genome sequencing technologies brings
the promise of a new era of precision therapeutics to clinical practice, but it is associated
with significant challenges, including reproducible generation of high-quality sequence data
and the need for comprehensive data analysis and interpretation that is translatable to
clinical action. Equally critical are the ethical, legal, and social issues surrounding the
introduction of WGS testing and its clinical application in multiethnic, multicultural
populations, particularly those who have historically experienced discrimination or even
unethical research practices. Of particular concern are issues surrounding the privacy,
ownership, storage, and use of WGS data.
sequencing of just the protein-coding exons, enrichment and sequencing of methylated DNA and
RNA or transcriptome-sequencing under the broad category term, Whole Genome Sequencing (WGS).
The development of rapid and low cost next-generation genome sequencing technologies brings
the promise of a new era of precision therapeutics to clinical practice, but it is associated
with significant challenges, including reproducible generation of high-quality sequence data
and the need for comprehensive data analysis and interpretation that is translatable to
clinical action. Equally critical are the ethical, legal, and social issues surrounding the
introduction of WGS testing and its clinical application in multiethnic, multicultural
populations, particularly those who have historically experienced discrimination or even
unethical research practices. Of particular concern are issues surrounding the privacy,
ownership, storage, and use of WGS data.
Inclusion Criteria:
- Any patient with a malignant diagnosis at the time of diagnosis or relapse
- Any age (minimum 0 days old)
- Male or Female
- Pregnant women are eligible for this study
- Patients may have existing, non-oncological genetic disorders
- Patients may have received any amount of prior treatment
- Participants (or their parent/legal guardian in the case of minors) must have the
ability to understand and the willingness to sign a written informed consent or assent
form
Exclusion Criteria:
- Subjects for whom sufficient cancer tissues are not available to meet the objectives
of the study.
- Cognitively impaired adults are excluded from participation
- Adults not able to consent for themselves are excluded from participation
- Prisoners may not participate in this study
We found this trial at
1
site
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Stuart S Winter, MD
Phone: 505-272-5073
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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