MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment

Cancer Clinical Trial

— MARIA  

Official title:

MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05219734
• Other study ID #: CR-001-016
• Status: Active, not recruiting
• Start date: November 29, 2021
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Invitae Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Cancer
• Colorectal Cancer
• Non Small Cell Lung Cancer
• Recurrence
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
United States	Columbus Regional Health	Columbus	Indiana
United States	Onslow Radiation	Jacksonville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Invitae Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Through study completion, up to 5 years
Primary	Relapse Free Survival		Measured through study completion, assessed yearly up to 3 years