UNITY: Universal Germline Testing in the Community
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This study seeks to enroll adult participants who have a diagnosis of a solid tumor cancer and are willing to undergo germline genetic testing for cancer risk using Invitae's Multi-Cancer gene panel. 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 participant's clinician will be asked to provide relevant medical history and demographic information to the sponsor in the form of electronic case report forms at 3 timepoints: 1 month following the results of the participants genetic testing, one year post genetic testing, and 2 years post genetic testing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: Invitae's 84 gene multi-cancer panel.
Invitae's Multi-Cancer panel analyzes 84 genes associated with hereditary cancers across major organ systems.
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Outcome Measures
Primary Outcome Measures
- Rate of Pathogenic Germline Variants (PGV) [Will be assessed at baseline only.]
Assess rate of PGVs in the trial participants using Invitae's 84 gene multi-cancer gene panel.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient has consented to germline genetic testing
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Patient has a histologically confirmed diagnosis of a solid tumor cancer
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Patient is willing to release previously collected tissue sample
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Patient is willing to provide research blood samples
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Patient must be at least 18 years of age
Exclusion Criteria:
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Patient is unable to consent.
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Patient with hematologic malignancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carolina Blood and Cancer Care Associates, PA' | Rock Hill | South Carolina | United States | 29732 |
Sponsors and Collaborators
- Invitae Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR-001-017