Universal Germline Testing in the Community

Cancer Clinical Trial

— UNITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416710
• Other study ID #: CR-001-017
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2022
• Source: Invitae Corporation
• Contact: Lee Ifhar
• Phone: 5512150508
• Email: lee.ifhar[@]invitae.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Solid Tumor
• Solid Tumor, Adult

Intervention

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.

Locations

Country	Name	City	State
United States	Carolina Blood and Cancer Care Associates, PA'	Rock Hill	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Invitae Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.