Recruiting

Genetic Testing

Sponsor:

Invitae Corporation

Code:

NCT05416710

Conditions

Cancer

Solid Tumor

Solid Tumor, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Invitae's 84 gene multi-cancer panel.

Study Details

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.

Conditions

Cancer

Solid Tumor

Solid Tumor, Adult

Study ID

NCT05416710

Start date

Jun 1, 2022

Status verified date

Dec, 2022

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Rate of Pathogenic Germline Variants (PGV) [ Time Frame: Will be assessed at baseline only. ]

Central Contacts and Locations

Central contacts

Lee Ifhar

5512150508lee.ifhar@invitae.com

Brandie Leach

brandie.leach@invitae.com

Locations

Carolina Blood and Cancer Care Associates, PA'

Recruiting

Rock Hill, South Carolina, United States, 29732

Contacts

Dhwani Mehta

dmehta@ccorn.net

Principal Investigator:

Niyati Nathwani, MD

More Information

Sponsor

Invitae Corporation

Last update posted

Dec 7, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Invitae Corporation on 2022-12-07.