CancerMARIANCT05219734
MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment
An observational study of Cancer and Solid Tumor, run by Invitae Corporation at 2 sites in United States.
Trial summary
This study recruits patient with solid tumor types for sample collection and monitoring. Participants will provide blood and archival tissue samples in order to create a Personalized Cancer Monitoring (PCM) assay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Non Small Cell Lung Cancer
- What is being tested?
- Personalized Cancer Monitoring (PCM)
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Nov 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This study seeks to enroll patients of all solid tumor types across many clinical sites with emphasis on early stage non-metastatic Colorectal, Non small cell lung cancer, breast, ovarian and bladder cancers.
Who may be able to join
- Stated ability to give informed consent by participant.
- Stated health status of participant as healthy enough to provide Biological Material.
- Individuals diagnosed with solid cancer of any type, including but not limited to colorectal, non-small cell lung, breast, ovarian and bladder cancers, regardless of the length of time since diagnosis and regardless of previous therapies.
- Participant is of any biological sex and >18 years of age
- Participant has not undergone a blood transfusion within the previous three weeks
Who cannot join
- Participants who are deemed medically unstable
- Participants who are deemed to be "difficult to draw" blood from.
- Participants who are <18 years of age
- Participants diagnosed with CNS cancers, sarcomas or hematologic malignancies such as leukemia or lymphoma .
- Participants with more than one primary cancer
- Participants with FFPE slides older than 10 years
Show all 9Show fewer
- Participants who are pregnant
- Any other reason that, in the Investigator's judgment, that would preclude the participant from being able to participate in the study
- Participants for which a pathology report is not available
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbus Regional Health
Columbus, Indiana, 47201
Onslow Radiation
Jacksonville, North Carolina, 28546
About this study
This study recruits patient with solid tumor types for sample collection and monitoring. Participants will provide blood and archival tissue samples in order to create a Personalized Cancer Monitoring (PCM) assay. This assay will be used to detect circulating tumor DNA (ctDNA) levels in the blood over time and hopefully contribute to improvements in residual disease detection methods for future patients.
Results from this assay will be provided to participants and providers but providers are not asked to change patient care based on this information.
Read the detailed description
This study involves collection of tumor tissue (from a standard biopsy and/or surgery) as well as blood samples over time in order to allow the creation of a Personalized Cancer Monitoring (PCM) assay. Additional blood samples are taken throughout the patient's treatment and follow-up period.
Each participant will submit one blood sample when they begin participation in the research study. Participants will be asked to submit follow up samples several times per year (annually, at minimum), with the exact frequency varying by stage and type of cancer. In general, participants will not be asked to come into the clinic more frequently than their already needed clinic visits.
If the cancer-specific mutations identified by the PCM are detected in the blood samples provided as part of the study, this may would suggests that residual cancer may be present. This is an observational study comparing MRD results to standard of care methods and collecting provider and patient perspectives, using surveys. Physicians will be informed of all PCM results in the form of a clinical report. Physicians are not asked to base treatment decisions on these results.
- Being tested
- Personalized Cancer Monitoring (PCM)
- Keywords
- minimal residual disease, MRD, ctDNA, circulating tumor DNA
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Urinary Bladder Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Cancer Monitoring (PCM)Diagnostic test
personalized molecular test for solid tumor cancer patients that may detect the presence of circulating tumor DNA (ctDNA) and molecular residual disease (MRD), also known as minimal residual disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Through study completion, up to 5 years
Relapse Free Survival
Measured: Measured through study completion, assessed yearly up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start29 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Invitae Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ed Esplin, MD, PhD, Study director, Invitae CorporationMichael Korn, Study director, Invitae Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219734
- Sponsor's protocol ID
- CR-001-016
- Acronym
- MARIA
- Status last verified
- Mar 2024
- First submitted
- 20 Dec 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Invitae may share de-identified information and data generated through the study with third parties, including biopharmaceutical companies and biomedical researchers (e.g. academic), for clinical trials, drug development, and other disease-related research purposes. Only a subset of Invitae personnel will have access to PHI. The PHI will be stored in a secure location and will only be made available to Invitae personnel involved in the Study. Any academic publication of data analysis from this Study will use de-identified information only.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment
- ClinicalTrials.gov ID
- NCT05219734
- Acronym / sponsor ID
- MARIA / CR-001-016
- Keywords
- minimal residual disease, MRD, ctDNA, circulating tumor DNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Invitae CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Feb 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 recruits patient with solid tumor types for sample collection and monitoring. Participants will provide blood and archival tissue samples in order to create a Personalized Cancer Monitoring (PCM) assay. This assay will be used to detect circulating tumor DNA (ctDNA) levels in the blood over time and hopefully contribute to improvements in residual disease detection methods for future patients.
Results from this assay will be provided to participants and providers but providers are not asked to change patient care based on this information.
Detailed description
This study involves collection of tumor tissue (from a standard biopsy and/or surgery) as well as blood samples over time in order to allow the creation of a Personalized Cancer Monitoring (PCM) assay. Additional blood samples are taken throughout the patient's treatment and follow-up period.
Each participant will submit one blood sample when they begin participation in the research study. Participants will be asked to submit follow up samples several times per year (annually, at minimum), with the exact frequency varying by stage and type of cancer. In general, participants will not be asked to come into the clinic more frequently than their already needed clinic visits.
If the cancer-specific mutations identified by the PCM are detected in the blood samples provided as part of the study, this may would suggests that residual cancer may be present. This is an observational study comparing MRD results to standard of care methods and collecting provider and patient perspectives, using surveys. Physicians will be informed of all PCM results in the form of a clinical report. Physicians are not asked to base treatment decisions on these results.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study seeks to enroll patients of all solid tumor types across many clinical sites with emphasis on early stage non-metastatic Colorectal, Non small cell lung cancer, breast, ovarian and bladder cancers.
Key inclusion criteria (5 listed)
- Stated ability to give informed consent by participant.
- Stated health status of participant as healthy enough to provide Biological Material.
- Individuals diagnosed with solid cancer of any type, including but not limited to colorectal, non-small cell lung, breast, ovarian and bladder cancers, regardless of the length of time since diagnosis and regardless of previous therapies.
- Participant is of any biological sex and >18 years of age
- Participant has not undergone a blood transfusion within the previous three weeks
Key exclusion criteria (9 listed)
- Participants who are deemed medically unstable
- Participants who are deemed to be "difficult to draw" blood from.
- Participants who are <18 years of age
- Participants diagnosed with CNS cancers, sarcomas or hematologic malignancies such as leukemia or lymphoma .
- Participants with more than one primary cancer
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 |
|---|---|---|
| Personalized Cancer Monitoring (PCM)personalized molecular test for solid tumor cancer patients that may detect the presence of circulating tumor DNA (ctDNA) and molecular residual disease (MRD), also known as minimal residual disease | Diagnostic test | – |
Primary outcome
Overall survival
Time frame: Through study completion, up to 5 years
Relapse Free Survival
Time frame: Measured through study completion, assessed yearly up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. Invitae may share de-identified information and data generated through the study with third parties, including biopharmaceutical companies and biomedical researchers (e.g. academic), for clinical trials, drug development, and other disease-related research purposes. Only a subset of Invitae personnel will have access to PHI. The PHI will be stored in a secure location and will only be made available to Invitae personnel involved in the Study. Any academic publication of data analysis from this Study will use de-identified information only.
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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.
Ed Esplin, MD, PhD study director
Invitae Corporation
Michael Korn study director
Invitae Corporation
2 sites 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 2 sites 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 9 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Through study completion, up to 5 years). The study lists 2 primary outcomes in all. 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 12 Mar 2024.