Clinical Performance Evaluation of the C2i-Test

  • STATUS
    Recruiting
  • End date
    Aug 5, 2025
  • participants needed
    260
  • sponsor
    C2i Genomics
Updated on 5 June 2022

Summary

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. This is a prospective non-interventional study to collect definitive evidence of the safety and effectiveness of C2i-Test for the intended use, in a statistically justified number of subjects.

Details
Condition Muscle-Invasive Bladder Carcinoma
Treatment C2i Test
Clinical Study IdentifierNCT05221827
SponsorC2i Genomics
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must have clinically and pathologically confirmed diagnosis of MIBC
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

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)
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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