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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Colorectal Cancer; Solid Tumor; Non Small Cell Lung Cancer; Bladder Cancer
• Intervention / Treatment: 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.

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Columbus, Indiana, United States, 47201
      • Columbus Regional Health
  • North Carolina
    • Jacksonville, North Carolina, United States, 28546
      • Onslow Radiation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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 with emphasis on early stage non-metastatic Colorectal, Non small cell lung cancer, breast, ovarian and bladder cancers.

Description

Inclusion Criteria

1. Stated ability to give informed consent by participant.
2. Stated health status of participant as healthy enough to provide Biological Material.
3. 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.
4. Participant is of any biological sex and >18 years of age
5. Participant has not undergone a blood transfusion within the previous three weeks

Exclusion Criteria

1. Participants who are deemed medically unstable
2. Participants who are deemed to be "difficult to draw" blood from.
3. Participants who are <18 years of age
4. Participants diagnosed with CNS cancers, sarcomas or hematologic malignancies such as leukemia or lymphoma .
5. Participants with more than one primary cancer
6. Participants with FFPE slides older than 10 years
7. Participants who are pregnant
8. Any other reason that, in the Investigator's judgment, that would preclude the participant from being able to participate in the study
9. Participants for which a pathology report is not available

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	Through study completion, up to 5 years
Relapse Free Survival	Measured through study completion, assessed yearly up to 3 years

Collaborators and Investigators

• Sponsor: Invitae Corporation
• Investigators: Study Director: Ed Esplin, MD, PhD, Invitae Corporation; Study Director: Michael Korn, Invitae Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: minimal residual disease; ctDNA; circulating tumor DNA; MRD
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: CR-001-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No