Clinical Performance Evaluation of the C2i Test

Muscle Invasive Bladder Cancer Clinical Trial

Official title:

Multi-Institutional Evaluation of C2i-Test Performance for Detecting Molecular Residual Disease (MRD) in Muscle-invasive Bladder Cancer Patients Undergoing Radical Cystectomy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05860543
• Other study ID #: STU-2023-0182
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Jacob Taylor, MD
• Phone: 214-645-8791
• Email: Jacob.Taylor[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a prospective non-interventional study to evaluate the specificity of the C2i-Test in predicting 2-year recurrence-free survival post- definitive treatment (RC/RC + adjuvant chemotherapy), compared to the gold standard (GS) diagnosis as determined by patient outcome (based on NCCN guidelines).

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. The C2i-Test is a single site assay performed in the C2i Genomics' CLIA-certified laboratory.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• C2i-WGS-MRD 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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