Universal Germline Testing in the Community (UNITY)

December 5, 2022 updated by: Invitae Corporation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Carolina Blood and Cancer Care Associates, PA'
        • Contact:
        • Principal Investigator:
          • Niyati Nathwani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with solid tumor cancer who are willing to undergo germline genetic testing and who can consent to the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Pathogenic Germline Variants (PGV)
Time Frame: Will be assessed at baseline only.
Assess rate of PGVs in the trial participants using Invitae's 84 gene multi-cancer gene panel.
Will be assessed at baseline only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Invitae Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-001-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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