Age
Item
1. is 18 years of age and older at time of consent signing
boolean
C0001779 (UMLS CUI [1])
Carcinoma in situ of bladder | Valrubicin Neoadjuvant Therapy
Item
2. have histologically confirmed diagnosis of cis of the bladder and received valrubicin induction therapy per the labeled indication.
boolean
C0154091 (UMLS CUI [1])
C0068314 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
Disease Free | Status post Neoadjuvant Therapy | Valrubicin Intravesical
Item
3. is disease-free following induction with intravesical valrubicin
boolean
C0012634 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0068314 (UMLS CUI [3,1])
C1522448 (UMLS CUI [3,2])
Biopsy Negative Duration | Status post Valrubicin Neoadjuvant Therapy
Item
disease-free is defined as negative biopsy 10 to 12 weeks after the initiation of valrubicin induction
boolean
C0005558 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0068314 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
Valrubicin Neoadjuvant Therapy | Instillation Weekly Quantity
Item
valrubicin induction is defined as having received at least 3 of 6 weekly instillations
boolean
C0068314 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0184959 (UMLS CUI [2,1])
C0332174 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Patient Available Clinical Trial | Patient Available Follow-up
Item
4. is available for the duration of the study including follow-up (minimum 12 months from randomization)
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
ECOG performance status
Item
5. have an eastern cooperative oncology group (ecog) performance status grade of 2 or less
boolean
C1520224 (UMLS CUI [1])
Absence Urothelial Carcinoma Involving Upper urinary tract | Absence Urothelial Carcinoma Involving Prostatic Urethra | Work up Extravesical | Radiologic Imaging Procedure | Biopsy
Item
6. have no evidence of urothelial carcinoma involving the upper urinary tract or prostatic urethra (confirmed by extravesical work up, which may include radiological imaging and/or biopsy) within 6 months prior to randomization
boolean
C0332197 (UMLS CUI [1,1])
C2145472 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0729865 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C2145472 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0458450 (UMLS CUI [2,4])
C0750430 (UMLS CUI [3,1])
C0442096 (UMLS CUI [3,2])
C3897780 (UMLS CUI [4])
C0005558 (UMLS CUI [5])
Females & males of reproductive potential Sexual Abstinence | Postmenopausal state Duration Sexual Abstinence | Females & males of reproductive potential Contraceptive methods | Postmenopausal state Duration Contraceptive methods
Item
7. subjects (male and female) of child-bearing potential (including female subjects who are post-menopausal for less than 1 year) must be willing to practice abstinence or effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment
boolean
C4034483 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0036899 (UMLS CUI [2,3])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
Informed Consent
Item
8. is able to understand and give written informed consent
boolean
C0021430 (UMLS CUI [1])
Carcinoma of bladder Muscle Invasive
Item
1. have current or previous history of muscle-invasive bladder cancer (mibc)
boolean
C0699885 (UMLS CUI [1,1])
C0026845 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
Lymph node positive | Metastatic Neoplasm to the Bladder
Item
2. current or previous history of lymph node positive and/or metastatic bladder cancer
boolean
C0746319 (UMLS CUI [1])
C0347011 (UMLS CUI [2])
Squamous cell carcinoma | Adenocarcinoma | Undifferentiated carcinoma of bladder
Item
3. have current evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder
boolean
C0007137 (UMLS CUI [1])
C0001418 (UMLS CUI [2])
C2188054 (UMLS CUI [3])
Cancer treatment Systemic | Cytotoxic Chemotherapy | Cytostatic chemotherapy | Immunotherapy | Therapeutic radiology procedure
Item
4. is currently receiving systemic anti-cancer therapy (cytotoxic/cytostatic, immunotherapy or radiation)
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0677881 (UMLS CUI [2])
C2609342 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Investigational New Drugs
Item
5. received treatment with an investigational agent within 30 days or 5 half-lives prior to randomization, whichever is longer
boolean
C0013230 (UMLS CUI [1])
Antineoplastic Agents Intravesical | Exception Valrubicin | Exception Mitomycin | Status post Transurethral resection of bladder neoplasm
Item
6. received treatment with an intravesical chemotherapeutic agent (other than valrubicin or a single administration of mitomycin c post-transurethral resection of bladder tumor [turbt]) within 3 months prior to randomization
boolean
C0003392 (UMLS CUI [1,1])
C1522448 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0068314 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002475 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0401496 (UMLS CUI [4,2])
Valrubicin | Exception Neoadjuvant Therapy
Item
7. received treatment with valrubicin other than induction within 3 months prior to randomization
boolean
C0068314 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
Medical contraindication Valrubicin
Item
8. have contraindication to valrubicin
boolean
C1301624 (UMLS CUI [1,1])
C0068314 (UMLS CUI [1,2])
Hypersensitivity Anthracyclines | Hypersensitivity Polyethoxylated castor oil
Item
known hypersensitivity to anthracyclines or polyoxyl castor oil
boolean
C0020517 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0071558 (UMLS CUI [2,2])
Low-capacity bladder | Instillation Amount Unable
Item
small bladder capacity, i.e. unable to tolerate a 75 ml instillation
boolean
C3554521 (UMLS CUI [1])
C0184959 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Urinary tract infection
Item
concurrent urinary tract infection
boolean
C0042029 (UMLS CUI [1])
Absolute neutrophil count | Hemoglobin measurement
Item
9. absolute neutrophil count (anc) <1000/µl and hemoglobin <10 g/dl
boolean
C0948762 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled
Item
10. have active cardiovascular disease such as myocardial infarction within the past 3 months, unstable angina pectoris, congestive heart failure (nyha class iii or iv) or uncontrolled cardiac arrhythmia
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0003811 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
11. female subjects who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Sexual Abstinence Unwilling | Childbearing Potential Contraceptive methods Unwilling
Item
12. subjects of childbearing potential who are unwilling to practice abstinence or effective contraception (as defined by investigator) during the study and for 30 days after last dose of study treatment
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Malignant Neoplasm Organ system diagnosed | Malignant Neoplasm Organ system Suspected | Malignant Neoplasm Organ system Treated | Malignant Neoplasm Organ system Untreated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Prior Therapy Prostate carcinoma Asymptomatic | Exception Surveillance Prostate carcinoma Asymptomatic | Exception Hormone Therapy Prostate carcinoma Asymptomatic
Item
13. have current or history of documented or suspected malignancy of any organ system (diagnosed, treated or untreated) within the past 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin and asymptomatic non-metastatic prostate cancer either previously successfully treated or currently under active surveillance or receiving hormone therapy only)
boolean
C0006826 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0460002 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C0460002 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4,1])
C0460002 (UMLS CUI [4,2])
C0332155 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0553723 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1514463 (UMLS CUI [7,2])
C0600139 (UMLS CUI [7,3])
C0231221 (UMLS CUI [7,4])
C1705847 (UMLS CUI [8,1])
C0733511 (UMLS CUI [8,2])
C0600139 (UMLS CUI [8,3])
C0231221 (UMLS CUI [8,4])
C1705847 (UMLS CUI [9,1])
C0279025 (UMLS CUI [9,2])
C0600139 (UMLS CUI [9,3])
C0231221 (UMLS CUI [9,4])
Intravesical Administration Receive Unable | Surgical Manipulation intravesical Receive Unable | Cystoscopy | Biopsy | Premedication Unsuccessful
Item
14. is unable to tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy) even with premedication
boolean
C0001562 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0185111 (UMLS CUI [2,1])
C0442124 (UMLS CUI [2,2])
C1514756 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0010702 (UMLS CUI [3])
C0005558 (UMLS CUI [4])
C0033045 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
Communicable Diseases
Item
15. have ongoing clinically significant active infections
boolean
C0009450 (UMLS CUI [1])
Medical condition Excludes Protocol Compliance | Mental condition Excludes Protocol Compliance | Medical condition Excludes Completion of clinical trial | Mental condition Excludes Completion of clinical trial
Item
16. have any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])