Identifying Molecular Drivers of Cancer | NCT02470715

Studies
Identifying Molecular Drivers of Cancer

NCT02470715

Sponsor

Avera McKennan Hospital & University Health Center

Status

Completed

Last Update Posted

May 25, 2018Actual

Enrollment

579Actual

Phase

Not provided

Conditions

Cancer
Tumor
Advanced Cancer

Interventions

Molecular profile

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014Actual

Primary Completion Date

May 22, 2018Actual

Completion Date

May 22, 2018Actual

First Submitted Date

Jun 9, 2015

First Submission Date that Met QC Criteria

Jun 10, 2015

First Posted Date

Jun 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2018

Last Update Posted Date

May 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

579Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Molecular profile		Molecular profiled group receiving treatment based on genetics	Genetic: Molecular profile

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Molecular profile	Genetic	Patients and their treating physician will obtain the patient's genetic risk assessment	Molecular profile

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who have been diagnosed with cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Leyland-Jones	Avera McKennan Hospital & University Health Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avera Cancer Institute		Sioux Falls	South Dakota	57105	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.