MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment (MARIA)

  • STATUS
    Recruiting
  • End date
    Dec 23, 2026
  • participants needed
    1000
  • sponsor
    Invitae Corporation
Updated on 23 March 2022
blood transfusion
primary cancer
solid tumor

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. 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.

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.

At minimum, 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, 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. 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

Details
Condition Cancer, Solid Tumor, Non Small Cell Lung Cancer, Colorectal Cancer, Bladder Cancer
Treatment Personalized Cancer Monitoring (PCM)
Clinical Study IdentifierNCT05219734
SponsorInvitae Corporation
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Stated ability to give informed consent by participant or legal authorized representative such as a parent or guardian prior to any study procedures being performed and capability of complying with the protocol and its requirements
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, 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

Exclusion Criteria

Participants who are deemed medically unstable
Participants who are deemed to be "difficult to draw
Participants who are <18 years of age
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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