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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05219734
Recruitment Status : Recruiting
First Posted : February 2, 2022
Last Update Posted : February 2, 2022
Sponsor:
Information provided by (Responsible Party):
Invitae Corporation

Brief 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.


Condition or disease Intervention/treatment
Cancer Solid Tumor Non Small Cell Lung Cancer Colorectal Cancer Bladder Cancer Diagnostic Test: Personalized Cancer Monitoring (PCM)

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.

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

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment
Actual Study Start Date : November 29, 2021
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Intervention Details:
  • Diagnostic Test: 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


Primary Outcome Measures :
  1. Overall survival [ Time Frame: Through study completion, up to 5 years ]
  2. Relapse Free Survival [ Time Frame: Measured through study completion, assessed yearly up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study seeks to enroll patients of all solid tumor types across many clinical sites.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05219734


Contacts
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Contact: Paige Black (415) 504-3658 paige.black@invitae.com
Contact: Amber Carter, MS, CGC amber.carter@invitae.com

Locations
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United States, California
Invitae Recruiting
San Francisco, California, United States, 94103
Contact: Paige Black, BA    415-504-3658    paige.black@invitae.com   
Contact: Amber Carter, MS, CGC       amber.carter@invitae.com   
Principal Investigator: Ed Esplin, MD, PhD         
Sponsors and Collaborators
Invitae Corporation
Investigators
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Principal Investigator: Ed Esplin, MD, PhD Invitae Corporation
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Responsible Party: Invitae Corporation
ClinicalTrials.gov Identifier: NCT05219734    
Other Study ID Numbers: CR-001-016
First Posted: February 2, 2022    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Invitae Corporation:
minimal residual disease
MRD
ctDNA
circulating tumor DNA
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes