Universal Germline Testing in the Community
UNITY
Prospective Community Cancer Clinics-based Approach to Optimize Germline Testing in Cancer Patients in Rural Setting to Address Racial Disparities: UNIversal Germline Testing in the communitY (UNITY) Study
1 other identifier
observational
1,000
1 country
1
Brief Summary
This study seeks to enroll participants who have a diagnosis of a solid tumor cancer and are willing to undergo germline genetic testing for cancer risk. At baseline, patients will be asked to provide 2 types of blood samples: 1 tube for clinical genetic testing and 2 tubes for future research use. A tumor sample from a previous resection or biopsy will also be obtained and sent to the sponsor. The clinician will be asked to provide relevant medical history and demographic information to the sponsor in the form of electronic case report forms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedDecember 7, 2022
December 1, 2022
3 years
June 9, 2022
December 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Pathogenic Germline Variants (PGV)
Assess rate of PGVs in the trial participants using Invitae's 84 gene multi-cancer gene panel.
Will be assessed at baseline only.
Study Arms (1)
Solid tumor cancers
Adult participants with a diagnosis of a solid tumor cancer who are able to consent to the study and who are interested in undergoing germline genetic testing will receive testing using Invitae's 84 gene Multi-Cancer panel.
Interventions
Invitae's Multi-Cancer panel analyzes 84 genes associated with hereditary cancers across major organ systems.
Eligibility Criteria
Adults with solid tumor cancer who are willing to undergo germline genetic testing and who can consent to the study.
You may qualify if:
- Patient has consented to germline genetic testing
- Patient has a histologically confirmed diagnosis of a solid tumor cancer
- Patient is willing to release previously collected tissue sample
- Patient is willing to provide research blood samples
- Patient must be at least 18 years of age
You may not qualify if:
- Patient is unable to consent.
- Patient with hematologic malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolina Blood and Cancer Care Associates, PA'
Rock Hill, South Carolina, 29732, United States
Biospecimen
Blood samples will be obtained as baseline for germline genetic testing (1 EDTA Tube with 4-7mL of blood) and future research use (2 Streck tubes for 20mL of blood total).
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2022
First Posted
June 13, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
December 7, 2022
Record last verified: 2022-12