Genetic Investigation of Solid Tumors Cohort | NCT01005225

Studies
Genetic Investigation of Solid Tumors Cohort

NCT01005225

Sponsor

Scripps Translational Science Institute

Status

Completed

Last Update Posted

Jun 12, 2014Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Prostate Cancer
Colon Cancer

Interventions

Not provided

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

Jun 2014

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

Feb 2008

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Oct 28, 2009

First Submission Date that Met QC Criteria

Oct 28, 2009

First Posted Date

Oct 30, 2009Estimated

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

Jun 10, 2014

Last Update Posted Date

Jun 12, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eric Topol, MD, Director, Scripps Translational Science InstitutePrincipal Investigator

Lead Sponsor

Scripps Translational Science InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 objective of this study is to obtain blood samples, solid tumor and/or benign hyperplasia samples to learn more about genetic differences that are linked to the formation of solid tumors.

Detailed Description

Recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop solid tumors. Even though it has been firmly established that if an individual carries these DNA variants they have an increased chance of developing a solid tumor the underlying biological mechanisms for most of these associations are largely unknown.

In addition to inherited DNA variants that are associated with the development of solid tumors it is well established that during the development and growth of solid tumors the DNA in these cancer cells undergo somatic changes (mutations). These somatic DNA changes have been studied over the past decade and frequently are specific chromosomal translocations and amplifications associated with the development of particular solid tumors. In some instances, examining the chromosomal translocation and amplification has lead to the discovery of proteins contributing to solid tumor pathology.

the human 8q24 interval that has strong genetic associations with solid tumor development has also been noted as frequently amplified in solid tumors and serves as a predictor of poor survival in prostate cancers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Solid tumors		Participants 18 years of age or older who have been diagnosed with a solid tumor or benign hyperplasia that needs surgical removal will be included in this study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Solid tumor biological insights	Obtain blood samples, solid tumor and/or benign hyperplasia samples, and in some instances normal tissue in order to gain biological insights into cancer (solid tumors) through population genetics and genomics.	Study completion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Eligible to have their blood drawn
Be reliable, cooperative and willing to comply with all protocol-specified procedures
Able to understand and grant informed consent
Diagnosis of a solid tumor

Exclusion Criteria:

Has a significant chronic medical condition which would potentially confound interpretation of the individual's phenotype.
Treatment with any investigational agents or devices within thirty days preceding enrollment in the study.
Been administered or taken any CNS sedatives or depressants in the 12 hours prior to informed consent process

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

Outpatient clinic, physician referral

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Mason, MD	Scripps Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Health		San Diego	California	92037	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Approximately 19.5 milliliters (mls) of blood will be collected in (2 x 8.5 ml) PAXgene DNA tubes and (1 x 2.5 ml) PAXgene RNA tube.

Solid tumor and/or benign hyperplasia samples will be collected from the participants during surgery scheduled for standard medical care.