Bladder Cancer Clinical Trial

MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment

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.

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Full 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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Bladder Cancer

Estimated Enrollment:

400

Study ID:

NCT05219734

Recruitment Status:

Recruiting

Sponsor:

Invitae Corporation

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There are 2 Locations for this study

See Locations Near You

Invitae
San Francisco California, 94103, United States More Info
Lee Ifhar, MS
Contact
551-215-0508
[email protected]
Ed Esplin, MD, PhD
Principal Investigator
Onslow Radiology
Jacksonville North Carolina, 94013, United States More Info
Darrel Ross, MD
Contact
910-577-4900
Vanessa Schmidt
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

400

Study ID:

NCT05219734

Recruitment Status:

Recruiting

Sponsor:


Invitae Corporation

How clear is this clinincal trial information?

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