Universal Germline Testing in the Community (UNITY)

Invitae

Status: Enrolling

Conditions: Solid Tumor; Solid Tumor, Adult; Cancer

Treatments: Diagnostic Test: Invitae's 84 gene multi-cancer panel.

Study type: Observational

Funder types: Industry

Identifiers

NCT05416710

CR-001-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Solid tumor cancers

Description:

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.

Treatment:

Diagnostic Test: Invitae's 84 gene multi-cancer panel.