Clinical Performance Evaluation of the C2i Test

NCT05860543 | Withdrawn

• 1 other identifier: STU-2023-0182
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall objective of this study is to demonstrate the safety and effectiveness by means of investigation of the ability of C2i-Test to predict 2-year recurrence-free survival post-RC in stage II-IIIA MIBC patients.

Conditions

Muscle Invasive Bladder Cancer

Keywords

C2i-Test; C2i-WGS-MRD Test; Muscle-invasive bladder cancer; MIBC; Whole-genome sequencing; WGS

Outcome Measures

Primary Outcomes (1)

• Specificity of the C2i-Test in predicting two-year recurrence-free survival

  Specificity will be derived from a two-by-two summary table of observed counts of positive or negative results by C2i-Test and the relevant GS and defined as: C2i-Test Specificity = True Negative /(True Negative +False Positive )

  At 2 years

Interventions

C2i-WGS-MRD Test DIAGNOSTIC_TEST

The C2i-WGS-MRD Test (hereinafter referred to as 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) in patients diagnosed with muscle-invasive bladder cancer (MIBC) and histopathologically classified as stage II-IIIA

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinically and pathologically confirmed diagnosis of muscle-invasive bladder cancer stage II-IIIIA will be recruited for the study

You may qualify if:

• Participants must have clinically and pathologically confirmed diagnosis of MIBC. Participants with MIBC, path T2-T4a N0/1 at cystectomy with imaging studies confirming no distant disease using cross-sectional imaging of abdomen and pelvis and chest imaging (chest X-ray or computed tomography).
• 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.
• Histopathologically confirmed urothelial carcinoma as diagnosed by cystectomy.
• A representative FFPE biopsy specimen (from the -cystectomy specimen) 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.
• 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.
• English or Spanish speakers
• Age of Subjects: subjects must be at least 22 years of age and older, or age of majority in their local jurisdiction. There is no upper age limit.
• Ability to understand and the willingness to provide an informed consent

You may not qualify if:

• Extravesical urothelial carcinoma (UC) that invades the pelvic and/or abdominal wall for bladder cancer (T4b) as evidenced by imaging.
• 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).
• 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).
• 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 & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Officials

• Yair Lotan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share