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

NCT03348137 | Withdrawn DMC

• 3 other identifiers: 0S-16-16NCI-2017-01450P30CA014089
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Questionnaire Administration OTHER

Ancillary studies

Ancillary-Correlative (questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consented to the Total Cancer Care Protocol protocol

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Gregory Idos, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2017
• First Posted: November 20, 2017
• Study Start: July 1, 2019
• Primary Completion (Estimated): July 1, 2037
• Study Completion (Estimated): July 1, 2038
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

US (1)