NCT02470715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
579

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2018

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

4.1 years

First QC Date

June 9, 2015

Last Update Submit

May 24, 2018

Conditions

CancerTumorAdvanced Cancer

Keywords

genetic sequencinggenomecancerDNARNAproteinmetabolite

Outcome Measures

Primary Outcomes (1)

  • Genetic profiling

    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.

    Up to 15 years

Study Arms (1)

Molecular profile

Molecular profiled group receiving treatment based on genetics

Genetic: Molecular profile

Interventions

Molecular profileGENETIC

Patients and their treating physician will obtain the patient's genetic risk assessment

Also known as: Genomic targeting
Molecular profile

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed with cancer

You may qualify if:

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

You may not qualify if:

  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Brian Leyland-Jones

    Avera McKennan Hospital & University Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 12, 2015

Study Start

April 1, 2014

Primary Completion

May 22, 2018

Study Completion

May 22, 2018

Last Updated

May 25, 2018

Record last verified: 2018-05

Locations

US(1)