Universal Germline Testing in the Community

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cancer, Solid Tumor, Solid Tumor, Adult

Intervention / Treatment
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* Diagnostic Test: Invitae's 84 gene multi-cancer panel.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patient is unable to consent. Patient with hematologic malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Solid tumor cancers<br>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.<br>* Invitae's Multi-Cancer panel analyzes 84 genes associated with hereditary cancers across major organ systems.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |