Clinical trial NCT05630131: ctDNA in Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy
Official title: Pilot Study to Evaluate the Role for Circulating Tumor DNA (ctDNA) in Monitoring Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bladder Cancer
Muscle-Invasive Bladder Carcinoma
Keywords: circulating tumor DNA
biospecimen
surgery
radiotherapy
chemotherapy
trimodality
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of North Carolina Patients

Brief summary: The purpose of this prospective biospecimen collection study is to evaluate the feasibility of measuring circulating tumor DNA (ctDNA) in subjects with muscle-invasive bladder cancer (MIBC) treated with trimodality therapy consisting of a maximal transurethral resection of bladder tumor followed by radiation and concomitant chemotherapy.

Cancer cells have unique genes that determine the characteristics of tumors, such as how they will respond to different treatments. The tumor tissue will be used to determine the genes present in cancer cells. Tumor cells sometimes release fragments of DNA into the blood or urine (circulating tumor DNA or ctDNA) and measuring levels of ctDNA may be a way to monitor cancer and predict to determine which treatment works better and what will be the outcome of cancer.

Urine, blood, and tumor tissue are called biospecimens. Biospecimens can help researchers understand how the human body works. Researchers may develop new tests to monitor diseases or new ways to treat diseases. Plasma and urine specimens will be collected before, during, and after the standard-of-care treatment.

This study will estimate the feasibility of collecting plasma ctDNA detection in subjects with MIBC. If this information can be successfully collected and processed, the usefulness of ctDNA to predict tumor response to certain kinds of treatment or disease progression will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
2. A diagnosis of Muscle-invasive Bladder Cancer with a plan to treat it with surgery, radiation, and chemotherapy
3. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.

Exclusion Criteria:

All subjects must not meet any of the following exclusion criteria prior to enrollment to participate in this study:

1. Any serious medical or psychiatric disorder that would interfere with the subject's ability to give informed consent.
2. Incarcerated individuals.

Primary outcomes:
measure: Feasibility of cell-free plasma ctDNA collection
timeFrame: Up to 2 years
Secondary outcomes:
measure: Feasibility of urine ctDNA collection
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Cancer Hospital (UNC)
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Matthew I Milowsky, MD
role: PRINCIPAL_INVESTIGATOR
References: