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

ORIEN-PROGENY Family History Questionnaire Study: Recognizing Inherited Susceptibility to Cancer

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03348137
Enrollment
0
Registered
2017-11-20
Start date
2019-07-01
Completion date
2038-07-01
Last updated
2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Neoplasm

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.

Interventions

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Southern California
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Rates of Genetic TestingUp to 30 monthsWill compare rates of genetic testing before and after implementation of Progeny Family History Questionnaire (FHQ) using the stratified Chi-square test.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026