CancerUNITYNCT05416710
Universal Germline Testing in the Community
An observational study of Cancer and Solid Tumor, run by Invitae Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Solid Tumor, Adult
- What is being tested?
- Invitae's 84 gene multi-cancer panel.
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with solid tumor cancer who are willing to undergo germline genetic testing and who can consent to the study.
Who may be able to join
- 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
Who cannot join
- Patient is unable to consent.
- Patient with hematologic malignancy
Trial locations and contacts
1 site in 1 country.
Brandie Leach contact
United States1 site, 1 recruiting
- Recruiting
Carolina Blood and Cancer Care Associates, PA'
Rock Hill, South Carolina, 29732
Dhwani Mehta, dmehta@ccorn.net
Niyati Nathwani, MD
About this study
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
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.
Read the 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.
- Conditions
- Cancer, Solid Tumor, Solid Tumor, Adult
- Being tested
- Invitae's 84 gene multi-cancer panel.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitae's 84 gene multi-cancer panel.Diagnostic test
Invitae's Multi-Cancer panel analyzes 84 genes associated with hereditary cancers across major organ systems.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Invitae's 84 gene multi-cancer panel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Pathogenic Germline Variants (PGV)
Assess rate of PGVs in the trial participants using Invitae's 84 gene multi-cancer gene panel.
Measured: Will be assessed at baseline only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Invitae Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416710
- Sponsor's protocol ID
- CR-001-017
- Acronym
- UNITY
- Status last verified
- Dec 2022
- First submitted
- 9 Jun 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05416710
- Acronym / sponsor ID
- UNITY / CR-001-017
- Conditions
- Cancer, Solid Tumor, Solid Tumor, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Invitae CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solid tumor cancers | – | Diagnostic Test: Invitae's 84 gene multi-cancer panel.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with solid tumor cancer who are willing to undergo germline genetic testing and who can consent to the study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient is unable to consent.
- Patient with hematologic malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitae's 84 gene multi-cancer panel.Invitae's Multi-Cancer panel analyzes 84 genes associated with hereditary cancers across major organ systems. | Diagnostic test | Solid tumor cancers |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandie Leach contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Solid Tumor, run by Invitae Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee Ifhar (5512150508, lee.ifhar@invitae.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Pathogenic Germline Variants (PGV) (time frame: Will be assessed at baseline only.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.