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Identifying Molecular Drivers of Cancer

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ClinicalTrials.gov Identifier: NCT02470715
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

Study Description
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Brief Summary:
The primary aim of this study is to identify drivers of cancer by performing comprehensive genetic, proteomic, and metabolomic characterization of patient samples as a basis for understanding the underlying cause of disease.

Condition or disease Intervention/treatment
Cancer Tumor Advanced Cancer Genetic: Molecular profile

Detailed Description:
This study involves looking at the DNA, RNA, proteins, and metabolites in blood and tissue samples collected from subjects and linking them to their health information. By doing so, researchers hope to discover the underlying molecular causes of human diseases with the hope that this information can be used for the development of diagnostic tests and more effective treatments.
Study Design
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Study Type : Observational
Actual Enrollment : 579 participants
Observational Model: Other
Time Perspective: Other
Official Title: Identifying Molecular Drivers of Cancer
Actual Study Start Date : April 2014
Actual Primary Completion Date : May 22, 2018
Actual Study Completion Date : May 22, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Molecular profile
Molecular profiled group receiving treatment based on genetics
 Genetic: Molecular profile
Patients and their treating physician will obtain the patient's genetic risk assessment
Other Name: Genomic targeting


Outcome Measures
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Primary Outcome Measures :
  1. Genetic profiling [ Time Frame: Up to 15 years ]
    To determine genetic changes associated with the development and growth of human disease. This should lead to better ways to detect, prevent, and treat a wide variety of human health conditions, including cancer.


Biospecimen Retention:   Samples With DNA

Participants will have up to 3 blood tubes (about 30 ml) drawn under the condition that protocol criteria for blood sampling is met. Blood samples may be collected each time a participant undergoes a provider-ordered blood draw. Urine samples may also be collected approximately every 4-6 weeks.

Participants may be asked to provide approximately 60-120 ml of first-morning-void urine. Tissue from a standard care surgical procedure or biopsy may be obtained. Additional core biopsies (for research) or excess surgical waste will be collected during each biopsy procedure when appropriate and will be processed and stored.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been diagnosed with cancer
Criteria

Inclusion Criteria:

  • Patients diagnoses with cancer but healthy enough to undergo a biopsy procedure
  • Between the ages of 18 and 100

Exclusion Criteria:

  • Patients who are pregnant
Contacts and Locations
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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): NCT02470715


Locations
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United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
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Principal Investigator: Brian Leyland-Jones Avera McKennan Hospital & University Health Center
More Information
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Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT02470715    
Other Study ID Numbers: AMEM-2014-CCD001
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Avera McKennan Hospital & University Health Center:
genetic sequencing
genome
cancer
DNA
 RNA
protein
metabolite