Genome Sequencing of Human Cancer Tissues

  • STATUS
    Recruiting
  • End date
    Dec 21, 2023
  • participants needed
    250
  • sponsor
    New Mexico Cancer Care Alliance
Updated on 21 May 2021
cancer treatment
primary cancer
cancer care

Summary

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.

Description

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.

Details
Condition malignancy, malignant tumor, malignancies, Cancer/Tumors, primary malignant neoplasm, cancers, Cancer (Pediatric), Cancer, malignant tumors, Neoplasms, primary cancer, Ewing's Family Tumors
Treatment Cancer Treatment Options
Clinical Study IdentifierNCT02105545
SponsorNew Mexico Cancer Care Alliance
Last Modified on21 May 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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