Clinical trial NCT05219734: MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment
Official title: MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Solid Tumor
Non Small Cell Lung Cancer
Colorectal Cancer
Bladder Cancer
Keywords: minimal residual disease
MRD
ctDNA
circulating tumor DNA
Lead sponsor: Invitae Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Through study completion, up to 5 years
measure: Relapse Free Survival
timeFrame: Measured through study completion, assessed yearly up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Columbus Regional Health
state: Indiana
city: Jacksonville
country: United States
facility: Onslow Radiation
state: North Carolina
Study officials:
affiliation: Invitae Corporation
name: Ed Esplin, MD, PhD
role: STUDY_DIRECTOR
affiliation: Invitae Corporation
name: Michael Korn
role: STUDY_DIRECTOR
References: