Oncology Research Information Exchange Network in Improvi... | NCT03348137

Studies
Oncology Research Information Exchange Network in Improving Genetic Screening Rate in Patients With Cancer

NCT03348137

Sponsor

University of Southern California

Status

Withdrawn

Last Update Posted

Oct 24, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Malignant Neoplasm

Interventions

Questionnaire Administration

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

ID	Type	Description	Link
NCI-2017-01450	Registry Identifier	CTRP (Clinical Trial Reporting Program)
0S-16-16	Other Identifier	USC / Norris Comprehensive Cancer Center
P30CA014089	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left

Expanded Access Info

Start Date

Jul 1, 2019Estimated

Primary Completion Date

Jul 1, 2037Estimated

Completion Date

Jul 1, 2038Estimated

First Submitted Date

Nov 4, 2017

First Submission Date that Met QC Criteria

Nov 15, 2017

First Posted Date

Nov 20, 2017Actual

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

Oct 21, 2019

Last Update Posted Date

Oct 24, 2019Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

This research trial studies how well Oncology Research Information Exchange Network (ORIEN) works in improving genetic screening rate in patients with cancer. Implementation of Progeny Genetic Pedigree and Family History Questionnaire software across all ORIEN member institutions may add value and utility for recognizing and caring for patients with an inherited susceptibility to cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. Measure the change in uptake of cancer genetic referrals and genetic testing in the ORIEN system of cancer centers implementing the Progeny Family History Questionnaire (FHQ).

SECONDARY OBJECTIVES:

I. Follow and estimate utilization of preventive health behaviors among Progeny FHQ users across all institutions.

II. Compare utilization of preventive health behavior between Progeny FHQ risk identification and genetic testing.

OUTLINE:

Patients take Progeny Genetic Pedigree and Family History Questionnaire. Results are reviewed by the site specific research coordinator and/or genetic counselor to assess whether a patient fulfills criteria for referral to the site specific cancer genetics clinic for further evaluation.

After completion of study, patients are followed up at 6 months after disclosure of genetic testing results.

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

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ancillary-Correlative (questionnaire)		Patients take Progeny Genetic Pedigree and Family History Questionnaire. Results are reviewed by the site specific research coordinator and/or genetic counselor to assess whether a patient fulfills criteria for referral to the site specific cancer genetics clinic for further evaluation.	Other: Questionnaire Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire Administration	Other	Ancillary studies	Ancillary-Correlative (questionnaire)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Rates of Genetic Testing	Will compare rates of genetic testing before and after implementation of Progeny Family History Questionnaire (FHQ) using the stratified Chi-square test.	Up to 30 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Limited to those patients who are consented to the Total Cancer Care Protocol (TCCP) protocol
Able to understand and sign the TCCP informed consent, California subject?s bill of rights, Health Insurance Portability and Accountability Act (HIPAA), and research authorization form directly or through an authorized representative; the informed consent, subject?s bill of rights, HIPAA, and research authorization will be available in both English and Spanish languages

Exclusion Criteria:

Individuals who are not registered as patients for outpatient or inpatient care to the TCCP protocol
Individuals who are unable to understand or sign the TCCP informed consent, subject?s bill of rights, HIPAA, and research authorization in either English or Spanish

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 consented to the Total Cancer Care Protocol protocol

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Idos, MD	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USC / Norris Comprehensive Cancer Center		Los Angeles	California	90033	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided