MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment

About this trial

Last updated 2 years ago

Study ID

CR-001-016

Status

Active not recruiting

Type

Observational

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started 4 years ago

What is this trial about?

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.

What are the participation requirements?

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