Universal Germline Testing in the Community

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-06-01

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.

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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.

Conditions

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Cancer Solid Tumor Solid Tumor, Adult

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Invitae's 84 gene multi-cancer panel.

Intervention Type DIAGNOSTIC_TEST

Invitae's Multi-Cancer panel analyzes 84 genes associated with hereditary cancers across major organ systems.

Interventions

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Invitae's 84 gene multi-cancer panel.

Invitae's Multi-Cancer panel analyzes 84 genes associated with hereditary cancers across major organ systems.

Intervention Type DIAGNOSTIC_TEST

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