We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Universal Germline Testing in the Community (UNITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05416710
Recruitment Status : Recruiting
First Posted : June 13, 2022
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cancer Solid Tumor Solid Tumor, Adult Diagnostic Test: Invitae's 84 gene multi-cancer panel.

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : June 1, 2026
Estimated Study Completion Date : June 1, 2026

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood samples will be obtained as baseline for germline genetic testing (1 EDTA Tube with 4-7mL of blood) and future research use (2 Streck tubes for 20mL of blood total).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05416710


Contacts
Layout table for location contacts
Contact: Paige Black 4155043658 clinical-research-coordination@invitae.com

Locations
Layout table for location information
United States, South Carolina
Carolina Blood and Cancer Care Associates, PA' Recruiting
Rock Hill, South Carolina, United States, 29732
Contact: Dhwani Mehta       dmehta@ccorn.net   
Principal Investigator: Niyati Nathwani, MD         
Sponsors and Collaborators
Invitae Corporation
Layout table for additonal information
Responsible Party: Invitae Corporation
ClinicalTrials.gov Identifier: NCT05416710    
Other Study ID Numbers: CR-001-017
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms