Cancer, Solid Tumor, Solid Tumor, Adult
Conditions
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.
Interventions
DIAGNOSTIC_TESTInvitae's 84 gene multi-cancer panel.
Invitae's Multi-Cancer panel analyzes 84 genes associated with hereditary cancers across major organ systems.
Sponsors
Invitae Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactLee Ifhar
Backup ContactBrandie Leach
Outcome results
None listed