Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3 participants
OBSERVATIONAL
2022-02-24
2022-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MIBC
Patients with clinically and pathologically confirmed diagnosis of MIBC stage II-IIIA, planned to undergo RC.
C2i Test
The C2i-Test, a personalized molecular circulating tumor DNA (ctDNA) test, is an in vitro qualitative test that uses next generation sequencing (NGS)-based whole-genome sequencing (WGS) data for detecting molecular residual disease (MRD).
Interventions
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C2i Test
The C2i-Test, a personalized molecular circulating tumor DNA (ctDNA) test, is an in vitro qualitative test that uses next generation sequencing (NGS)-based whole-genome sequencing (WGS) data for detecting molecular residual disease (MRD).
Eligibility Criteria
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Inclusion Criteria
* A representative FFPE biopsy specimen (from the transurethral resection of bladder tumor - TURBT) with at least 1 H\&E slide and 9 unstained slides, with an associated pathology report must be available.
* Subjects must agree to 8mL blood collection during all visits.
* Participants with MIBC, clinical stage II (cT2, N0) or IIIA (cT3, N0; cT4a, N0; cT1-T4a, N1) (lymph node positive if \>10 mm on CT or MRI in short axis), diagnosed by work-up recommended by NCCN guidelines (including cystoscopy, abdominal/pelvic imaging that includes imaging of upper urinary tract collecting system, examination under anesthesia, TURBT, and bone imaging if clinical suspicion or symptoms of bone metastases within 4 weeks prior to enrollment, however patients can be enrolled if they are reassessed, and the localized status is reconfirmed with subsequent imaging studies).
* Histopathologically confirmed urothelial carcinoma as diagnosed by TURBT. Variant urothelial histology (e.g., micropapillary, plasmacytoid, sarcomatoid, nested variant, lymphoepithelioid, nested variant) is acceptable. Mixed histology (adenocarcinoma, squamous cell) is acceptable if there is a predominant (\>50%) urothelial component.
* Treatment plans must include RC.
* Participant is willing and able to comply with the protocol, including RC, pelvic lymph node dissection (PLND), and prostatectomy (if applicable).
* The patient must be deemed appropriate for RC, PLND, and prostatectomy (if applicable) by his/her oncologist and/or urologist.
* Patient's treatment plan may or may not include neoadjuvant treatment and/or adjuvant treatment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
* Patient is willing and able to provide written informed consent for samples to be collected and used in this study.
Exclusion Criteria
* Evidence of UC in the urinary tract (ureters, renal pelvis, and urethra) as evidenced by work-up in accordance with NCCN guidelines (e.g., abdominal/pelvic imaging) that includes imaging of upper urinary tract collecting system).
* Clinical evidence of greater than 1 positive LN (≥ 10 mm in short axis) or metastatic bladder cancer per IV contrast-enhanced CT or MRI scan and/or PET-CT scan.
* Patients with mixed histology and \<50% urothelial component as evidenced by TURBT pathology.
* Tumors that contain any neuroendocrine/small cell component as evidenced by TURBT pathology.
* Diagnosis of 3 or more synchronous cancers.
* Malignancies other than urothelial cancer within 5 years prior to study entry except those with negligible risk of metastases or death and treated with the expectation of curative outcome (such as: carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated surgically with curative intent, papillary thyroid carcinoma, localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse, or incidental prostate cancer \[Gleason score ≤ 3 + 4 and PSA \< 10 ng/mL\] undergoing active surveillance and treatment naïve).
* Prior chemotherapy or immunotherapy, radiation therapy, or surgery other than TURBT for bladder cancer.
* Per physician discretion: patients with severe or uncontrolled concomitant medical, surgical, or psychiatric disease that could affect compliance with the protocol, the results of the study, or interpretation of the results.
* Individuals who cannot provide consent for their own participation will not be included.
* Sponsors employees and their family.
22 Years
100 Years
ALL
No
Sponsors
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New Jersey Urology
UNKNOWN
University of Texas
OTHER
Baylor College of Medicine
OTHER
NY Health d/b/a New York Cancer and Blood Specialists
OTHER
The Cleveland Clinic
OTHER
Fox Chase Cancer Center
OTHER
New York University
OTHER
University of Washington
OTHER
Oregon Health and Science University
OTHER
University of Southern California
OTHER
Ohio State University
OTHER
C2i Genomics
INDUSTRY
Responsible Party
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Principal Investigators
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Yair Lotan, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern
Locations
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New Jersey Urology
Bloomfield, New Jersey, United States
Countries
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Other Identifiers
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CA-F01-02
Identifier Type: -
Identifier Source: org_study_id
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