Muscle-Invasive Bladder CarcinomaNCT05221827
Clinical Performance Evaluation of the C2i-Test
An observational study of Muscle-Invasive Bladder Carcinoma, run by C2i Genomics at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 100 years
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma
- What is being tested?
- C2i Test
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2022to 27 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients with clinically and pathologically confirmed diagnosis of MIBC stage II-IIIA, planned to undergo RC.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance Evaluation of the C2i-Test for Detecting Molecular Residual Disease (MRD) in Bladder Cancer Patients.
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.
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Being tested
- C2i Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2i TestDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| MIBC | Patients with clinically and pathologically confirmed diagnosis of MIBC stage II-IIIA, planned to undergo RC. Receives: Diagnostic Test: C2i Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall specificity of the C2i-Test
Predicting 3-year recurrence-free survival post- definitive treatment (RC/RC + adjuvant chemotherapy), compared to the GS diagnosis as determined by patient outcome (based on NCCN guidelines).
Measured: 3-year
Secondary outcomes (1)
Overall sensitivity of the C2i-Test
Predicting non-pCR following neoadjuvant treatment completion prior to RC, compared to the GS diagnosis as determined by the pathology report.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start24 Feb 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Why it stopped: Not in line with company's recently updated clinical development strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- C2i Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Jersey Urology, University of Texas, Baylor College of Medicine, NY Health d/b/a New York Cancer and Blood Specialists, The Cleveland Clinic, Fox Chase Cancer Center, New York University, University of Washington, Oregon Health and Science University, University of Southern California, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Yair Lotan, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221827
- Sponsor's protocol ID
- CA-F01-02
- Status last verified
- Feb 2023
- First submitted
- 19 Jan 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of the C2i-Test for Detecting Molecular Residual Disease (MRD) in Bladder Cancer Patients.
- ClinicalTrials.gov ID
- NCT05221827
- Acronym / sponsor ID
- CA-F01-02
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not in line with company's recently updated clinical development strategy
- Enrolment
- 3 participants (actual)
- Lead sponsor
- C2i GenomicsIndustry (pharma, biotech, devices)
- Collaborators
- New Jersey Urology, University of Texas, Baylor College of Medicine, NY Health d/b/a New York Cancer and Blood Specialists, The Cleveland Clinic, Fox Chase Cancer Center, New York University, University of Washington, Oregon Health and Science University, University of Southern California, Ohio State University
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIBC | – | Diagnostic Test: C2i TestPatients with clinically and pathologically confirmed diagnosis of MIBC stage II-IIIA, planned to undergo RC. |
Who may qualify
- Ages
- 22 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically and pathologically confirmed diagnosis of MIBC stage II-IIIA, planned to undergo RC.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C2i TestThe 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). | Diagnostic test | MIBC |
Primary outcome
Overall specificity of the C2i-Test
Time frame: 3-year
Predicting 3-year recurrence-free survival post- definitive treatment (RC/RC + adjuvant chemotherapy), compared to the GS diagnosis as determined by patient outcome (based on NCCN guidelines).
1 secondary outcome
Overall sensitivity of the C2i-Test
Time frame: 3-year
Results and safety
The study was stopped early (reason given: Not in line with company's recently updated clinical development strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Lotan, MD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-Invasive Bladder Carcinoma, run by C2i Genomics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not in line with company's recently updated clinical development strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall specificity of the C2i-Test (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.