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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Recruitment Status : Withdrawn (PI left)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

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.

Condition or disease Intervention/treatment
Malignant Neoplasm Other: Questionnaire Administration

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ORIEN-PROGENY Family History Questionnaire Study: Recognizing Inherited Susceptibility to Cancer
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2037
Estimated Study Completion Date : July 1, 2038

Group/Cohort Intervention/treatment
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
Ancillary studies




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients consented to the Total Cancer Care Protocol protocol
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348137


Locations
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United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gregory Idos, MD University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03348137     History of Changes
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 )
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms