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

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ClinicalTrials.gov Identifier: NCT03348137
Recruitment Status : Withdrawn (PI left)
First Posted : November 20, 2017
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date November 4, 2017
First Posted Date November 20, 2017
Last Update Posted Date October 24, 2019
Estimated Study Start Date July 1, 2019
Estimated Primary Completion Date July 1, 2037   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2017)
Changes in Rates of Genetic Testing [ Time Frame: Up to 30 months ]
Will compare rates of genetic testing before and after implementation of Progeny Family History Questionnaire (FHQ) using the stratified Chi-square test.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03348137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oncology Research Information Exchange Network in Improving Genetic Screening Rate in Patients With Cancer
Official Title ORIEN-PROGENY Family History Questionnaire Study: Recognizing Inherited Susceptibility to Cancer
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients consented to the Total Cancer Care Protocol protocol
Condition Malignant Neoplasm
Intervention Other: Questionnaire Administration
Ancillary studies
Study Groups/Cohorts 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.
Intervention: Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: October 21, 2019)
0
Original Estimated Enrollment
 (submitted: November 15, 2017)
45000
Estimated Study Completion Date July 1, 2038
Estimated Primary Completion Date July 1, 2037   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03348137
Other Study ID Numbers 0S-16-16
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Southern California
Study Sponsor University of Southern California
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Gregory Idos, MD University of Southern California
PRS Account University of Southern California
Verification Date October 2019