Muscle Invasive Bladder CancerNCT05860543
Clinical Performance Evaluation of the C2i Test
An observational study of Muscle Invasive Bladder Cancer, run by University of Texas Southwestern Medical Center.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Muscle Invasive Bladder Cancer
- What is being tested?
- C2i-WGS-MRD Test
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to 1 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically and pathologically confirmed diagnosis of muscle-invasive bladder cancer stage II-IIIIA will be recruited for the study
Who may be able to join
- 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).
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- 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
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).
- 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.
About this study
Official title: Multi-Institutional Evaluation of C2i-Test Performance for Detecting Molecular Residual Disease (MRD) in Muscle-invasive Bladder Cancer Patients Undergoing Radical Cystectomy.
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.
Read the detailed 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.
- Conditions
- Muscle Invasive Bladder Cancer
- Being tested
- C2i-WGS-MRD Test
- Keywords
- C2i-Test, C2i-WGS-MRD Test, Muscle-invasive bladder cancer, MIBC, Whole-genome sequencing, WGS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2i-WGS-MRD TestDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study startAug 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: C2i genomics was acquired by veracyte
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yair lotan, University of Texas Southwestern Medical Center
- Investigators
- Yair Lotan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860543
- Sponsor's protocol ID
- STU-2023-0182
- Status last verified
- Sep 2024
- First submitted
- 5 May 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Institutional Evaluation of C2i-Test Performance for Detecting Molecular Residual Disease (MRD) in Muscle-invasive Bladder Cancer Patients Undergoing Radical Cystectomy.
- ClinicalTrials.gov ID
- NCT05860543
- Acronym / sponsor ID
- STU-2023-0182
- Conditions
- Muscle Invasive Bladder Cancer
- Keywords
- C2i-Test, C2i-WGS-MRD Test, Muscle-invasive bladder cancer, MIBC, Whole-genome sequencing, WGS
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: C2i genomics was acquired by veracyte
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 May 2023 (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 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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically and pathologically confirmed diagnosis of muscle-invasive bladder cancer stage II-IIIIA will be recruited for the study
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (8 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).
- 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.
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-WGS-MRD TestThe 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 | Diagnostic test | – |
Primary outcome
Specificity of the C2i-Test in predicting two-year recurrence-free survival
Time frame: At 2 years
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 )
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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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
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Invasive Bladder Cancer, run by University of Texas Southwestern Medical Center.
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 12 inclusion and 8 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: withdrawn, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Specificity of the C2i-Test in predicting two-year recurrence-free survival (time frame: At 2 years). 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 25 Sep 2024.