ID

38606

Description

Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder; ODM derived from: https://clinicaltrials.gov/show/NCT01310803

Link

https://clinicaltrials.gov/show/NCT01310803

Keywords

Versions (1)
  1. 10/27/19 10/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma in Situ NCT01310803

English

Eligibility Carcinoma in Situ NCT01310803

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. is 18 years of age and older at time of consent signing
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. have histologically confirmed diagnosis of cis of the bladder and received valrubicin induction therapy per the labeled indication.
Description

Carcinoma in situ of bladder | Valrubicin Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0154091
UMLS CUI [2,1]
C0068314
UMLS CUI [2,2]
C0600558
3. is disease-free following induction with intravesical valrubicin
Description

Disease Free | Status post Neoadjuvant Therapy | Valrubicin Intravesical

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0600558
UMLS CUI [3,1]
C0068314
UMLS CUI [3,2]
C1522448
disease-free is defined as negative biopsy 10 to 12 weeks after the initiation of valrubicin induction
Description

Biopsy Negative Duration | Status post Valrubicin Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0068314
UMLS CUI [2,3]
C0600558
valrubicin induction is defined as having received at least 3 of 6 weekly instillations
Description

Valrubicin Neoadjuvant Therapy | Instillation Weekly Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0068314
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C0184959
UMLS CUI [2,2]
C0332174
UMLS CUI [2,3]
C1265611
4. is available for the duration of the study including follow-up (minimum 12 months from randomization)
Description

Patient Available Clinical Trial | Patient Available Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C3274571
5. have an eastern cooperative oncology group (ecog) performance status grade of 2 or less
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
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
Description

Absence Urothelial Carcinoma Involving Upper urinary tract | Absence Urothelial Carcinoma Involving Prostatic Urethra | Work up Extravesical | Radiologic Imaging Procedure | Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C2145472
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0729865
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C2145472
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0458450
UMLS CUI [3,1]
C0750430
UMLS CUI [3,2]
C0442096
UMLS CUI [4]
C3897780
UMLS CUI [5]
C0005558
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
Description

Females & males of reproductive potential Sexual Abstinence | Postmenopausal state Duration Sexual Abstinence | Females & males of reproductive potential Contraceptive methods | Postmenopausal state Duration Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0036899
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0449238
UMLS CUI [4,3]
C0700589
8. is able to understand and give written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have current or previous history of muscle-invasive bladder cancer (mibc)
Description

Carcinoma of bladder Muscle Invasive

Data type

boolean

Alias
UMLS CUI [1,1]
C0699885
UMLS CUI [1,2]
C0026845
UMLS CUI [1,3]
C0205281
2. current or previous history of lymph node positive and/or metastatic bladder cancer
Description

Lymph node positive | Metastatic Neoplasm to the Bladder

Data type

boolean

Alias
UMLS CUI [1]
C0746319
UMLS CUI [2]
C0347011
3. have current evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder
Description

Squamous cell carcinoma | Adenocarcinoma | Undifferentiated carcinoma of bladder

Data type

boolean

Alias
UMLS CUI [1]
C0007137
UMLS CUI [2]
C0001418
UMLS CUI [3]
C2188054
4. is currently receiving systemic anti-cancer therapy (cytotoxic/cytostatic, immunotherapy or radiation)
Description

Cancer treatment Systemic | Cytotoxic Chemotherapy | Cytostatic chemotherapy | Immunotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0677881
UMLS CUI [3]
C2609342
UMLS CUI [4]
C0021083
UMLS CUI [5]
C1522449
5. received treatment with an investigational agent within 30 days or 5 half-lives prior to randomization, whichever is longer
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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
Description

Antineoplastic Agents Intravesical | Exception Valrubicin | Exception Mitomycin | Status post Transurethral resection of bladder neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1522448
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0068314
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002475
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0401496
7. received treatment with valrubicin other than induction within 3 months prior to randomization
Description

Valrubicin | Exception Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0068314
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600558
8. have contraindication to valrubicin
Description

Medical contraindication Valrubicin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0068314
known hypersensitivity to anthracyclines or polyoxyl castor oil
Description

Hypersensitivity Anthracyclines | Hypersensitivity Polyethoxylated castor oil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0282564
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0071558
small bladder capacity, i.e. unable to tolerate a 75 ml instillation
Description

Low-capacity bladder | Instillation Amount Unable

Data type

boolean

Alias
UMLS CUI [1]
C3554521
UMLS CUI [2,1]
C0184959
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1299582
concurrent urinary tract infection
Description

Urinary tract infection

Data type

boolean

Alias
UMLS CUI [1]
C0042029
9. absolute neutrophil count (anc) <1000/µl and hemoglobin <10 g/dl
Description

Absolute neutrophil count | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0518015
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
Description

Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1275491
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205318
11. female subjects who are pregnant or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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
Description

Childbearing Potential Sexual Abstinence Unwilling | Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
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)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0460002
UMLS CUI [1,3]
C0011900
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0460002
UMLS CUI [2,3]
C0750491
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0460002
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0460002
UMLS CUI [4,3]
C0332155
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0553723
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1514463
UMLS CUI [7,3]
C0600139
UMLS CUI [7,4]
C0231221
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0733511
UMLS CUI [8,3]
C0600139
UMLS CUI [8,4]
C0231221
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0279025
UMLS CUI [9,3]
C0600139
UMLS CUI [9,4]
C0231221
14. is unable to tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy) even with premedication
Description

Intravesical Administration Receive Unable | Surgical Manipulation intravesical Receive Unable | Cystoscopy | Biopsy | Premedication Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0001562
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0185111
UMLS CUI [2,2]
C0442124
UMLS CUI [2,3]
C1514756
UMLS CUI [2,4]
C1299582
UMLS CUI [3]
C0010702
UMLS CUI [4]
C0005558
UMLS CUI [5,1]
C0033045
UMLS CUI [5,2]
C1272705
15. have ongoing clinically significant active infections
Description

Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
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
Description

Medical condition Excludes Protocol Compliance | Mental condition Excludes Protocol Compliance | Medical condition Excludes Completion of clinical trial | Mental condition Excludes Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C2732579
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Similar models

Eligibility Carcinoma in Situ NCT01310803

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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