Universal Germline Testing in the Community

Recruiting

• Conditions: Solid Tumor; Solid Tumor, Adult; Cancer
• Interventions: Diagnostic Test: Invitae's 84 gene multi-cancer panel.

• Registration Number: NCT05416710
• Lead Sponsor: Invitae Corporation

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.

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 Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-13
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solid tumor cancers	Invitae's 84 gene multi-cancer panel.	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Carolina Blood and Cancer Care Associates, PA'; 🇺🇸 Rock Hill, South Carolina, United States