Genome Sequencing of Human Cancer Tissues

NCT02105545 | Completed DMC

• 1 other identifier: INST 1306
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

cancer; oncology; malignant; malignancy; genetics; genomics; exome; DNA; RNA; sequencing; epigenetic; clinically actionable findings; CAF; secondary findings; SF; single nucleotide variants; SNV; bioinformatics; genotype; The American College of Medical Genetics and Genomics; ACMG

Outcome Measures

Primary Outcomes (1)

• Number of patients with clinically actionable findings

  The investigators will utilize new genomics technologies in to identify potentially Clinically Actionable Findings (CAF) in patient tumor and other samples. Based on individual patient data, alternative treatment options will be offered to patients.

  3 years

Secondary Outcomes (5)

• Frequency of findings (CAF) in cancer patients treated locally

  3 years

• Percentages and types of local patient CAF aligned with national genomics data sets

  3 years

• Number of barriers limiting use of genomics information in local patient care

  3 years

• Percentage of patients with secondary findings (SF)

  2 years

• Percentages and types of local patient Secondary Findings aligned with national genomics data sets

  3 years

Study Arms (1)

Cancer Treatment Options

EXPERIMENTAL

Blood samples and, for some patients, buccal (mouth cell) samples will be collected at diagnosis and/or relapse. Solid tumor samples will be collected in the normal course of treatment, from biopsy, blood or other specimens. For blood-based cancers such as leukemia, blood and bone marrow specimens will be collected before treatment begins, on day 29 and possibly at a later time point if relapse occurs.

Other: Cancer Treatment Options

Interventions

Cancer Treatment Options OTHER

Patients may meet, depending on test results, with their physician and a genetic counselor to discuss possible changes in their treatment options and/or lifestyle changes.

Also known as: treatment options, lifestyle changes, behavioral changes, genetics

Cancer Treatment Options

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Related Links

• University of New Mexico Cancer Center
• New Mexico Cancer Care Alliance

MeSH Terms

Conditions

Neoplasms

Study Officials

• Stuart S Winter, MD

  University of New Mexico Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: April 7, 2014
• Study Start: January 1, 2015
• Primary Completion: July 9, 2021
• Study Completion: April 23, 2023
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)