ID

19755

Beskrivning

Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00172367

Länk

https://clinicaltrials.gov/show/NCT00172367

Nyckelord

Versioner (1)
  1. 2017-01-27 2017-01-27 -
Uppladdad den

27 januari 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Transitional Cell NCT00172367

Engelsk

Eligibility Carcinoma, Transitional Cell NCT00172367

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients have pathologically-proven urothelial carcinoma (uc) with a clinical stage <= t3n0m0
Beskrivning

Urothelial Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2145472
UMLS CUI [1,2]
C3258246
patients have no visible or identifiable residual uc after treatment with a life expectancy of > 6 months
Beskrivning

Urothelial Carcinoma Residual post treatment | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2145472
UMLS CUI [1,2]
C1609982
UMLS CUI [1,3]
C2709088
UMLS CUI [2]
C0023671
patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded)
Beskrivning

Urothelium Remaining At risk Recurrence | Transplanted kidney Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0227598
UMLS CUI [1,2]
C1527428
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0034897
UMLS CUI [2,1]
C1261317
UMLS CUI [2,2]
C2828389
no other active malignancy. patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year.
Beskrivning

Malignant Neoplasm | primary tumor Treated Successful | primary tumor Cured | primary tumor remission

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C1272703
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C1880198
UMLS CUI [4,1]
C0677930
UMLS CUI [4,2]
C0544452
patients are able to take lycopene capsules orally.
Beskrivning

Able to swallow Lycopene Oral Capsule

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C1253418
patients who sign and give informed consents and are willing to conform to the scheduled sampling of the blood, urine and/or tissue
Beskrivning

Informed Consent | Compliance behavior | Blood specimen | Urine sample obtained | Tissue specimen

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
UMLS CUI [3]
C0178913
UMLS CUI [4]
C1277699
UMLS CUI [5]
C1292533
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have clinical stage > t3n0m0 or metastatic disease
Beskrivning

TNM clinical staging | Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C0027627
positive urine cytology. patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). if no recurrent or residual tumors are found, patients are still eligible for the study.
Beskrivning

Urine cytology Positive | diagnostic procedure Series | Echocardiography renal | Cystoscopy | Diagnostic ureterorenoscopy | imaging studies | Intravenous pyelogram | CT Urography | MRI of urinary tract | Retrograde pyelogram | Antegrade pyelography | Recurrent tumor | Residual Tumor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2979983
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0430022
UMLS CUI [2,2]
C0205549
UMLS CUI [3,1]
C0013516
UMLS CUI [3,2]
C0022646
UMLS CUI [4]
C0010702
UMLS CUI [5]
C1283825
UMLS CUI [6]
C1881134
UMLS CUI [7]
C0203108
UMLS CUI [8]
C1504583
UMLS CUI [9]
C1634512
UMLS CUI [10]
C0203110
UMLS CUI [11]
C0845988
UMLS CUI [12]
C0521158
UMLS CUI [13]
C0543478
patients who have ever received systemic chemotherapy within 12 months
Beskrivning

Systemic Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1883256
patients who have gastrointestinal malabsorption regardless of the etiology
Beskrivning

Malabsorption gastrointestinal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714745
UMLS CUI [1,2]
C0521362
have known allergic reaction to tomato or lycopene
Beskrivning

Allergy to tomato | Allergic Reaction lycopene

Datatyp

boolean

Alias
UMLS CUI [1]
C1623747
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0065331
patients who are participating or will participate in other clinical trials
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
patients who have active urinary tract infection can not be accrued until infection is effectively controlled
Beskrivning

Urinary tract infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0042029
patient's age is less than 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Carcinoma, Transitional Cell NCT00172367

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Urothelial Carcinoma TNM clinical staging
Item
patients have pathologically-proven urothelial carcinoma (uc) with a clinical stage <= t3n0m0
boolean
C2145472 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Urothelial Carcinoma Residual post treatment | Life Expectancy
Item
patients have no visible or identifiable residual uc after treatment with a life expectancy of > 6 months
boolean
C2145472 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C2709088 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2])
Urothelium Remaining At risk Recurrence | Transplanted kidney Excluded
Item
patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded)
boolean
C0227598 (UMLS CUI [1,1])
C1527428 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,4])
C1261317 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Malignant Neoplasm | primary tumor Treated Successful | primary tumor Cured | primary tumor remission
Item
no other active malignancy. patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year.
boolean
C0006826 (UMLS CUI [1])
C0677930 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
C0677930 (UMLS CUI [3,1])
C1880198 (UMLS CUI [3,2])
C0677930 (UMLS CUI [4,1])
C0544452 (UMLS CUI [4,2])
Able to swallow Lycopene Oral Capsule
Item
patients are able to take lycopene capsules orally.
boolean
C2712086 (UMLS CUI [1,1])
C1253418 (UMLS CUI [1,2])
Informed Consent | Compliance behavior | Blood specimen | Urine sample obtained | Tissue specimen
Item
patients who sign and give informed consents and are willing to conform to the scheduled sampling of the blood, urine and/or tissue
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C0178913 (UMLS CUI [3])
C1277699 (UMLS CUI [4])
C1292533 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
TNM clinical staging | Neoplasm Metastasis
Item
patients who have clinical stage > t3n0m0 or metastatic disease
boolean
C3258246 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Urine cytology Positive | diagnostic procedure Series | Echocardiography renal | Cystoscopy | Diagnostic ureterorenoscopy | imaging studies | Intravenous pyelogram | CT Urography | MRI of urinary tract | Retrograde pyelogram | Antegrade pyelography | Recurrent tumor | Residual Tumor
Item
positive urine cytology. patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). if no recurrent or residual tumors are found, patients are still eligible for the study.
boolean
C2979983 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0430022 (UMLS CUI [2,1])
C0205549 (UMLS CUI [2,2])
C0013516 (UMLS CUI [3,1])
C0022646 (UMLS CUI [3,2])
C0010702 (UMLS CUI [4])
C1283825 (UMLS CUI [5])
C1881134 (UMLS CUI [6])
C0203108 (UMLS CUI [7])
C1504583 (UMLS CUI [8])
C1634512 (UMLS CUI [9])
C0203110 (UMLS CUI [10])
C0845988 (UMLS CUI [11])
C0521158 (UMLS CUI [12])
C0543478 (UMLS CUI [13])
Systemic Chemotherapy
Item
patients who have ever received systemic chemotherapy within 12 months
boolean
C1883256 (UMLS CUI [1])
Malabsorption gastrointestinal
Item
patients who have gastrointestinal malabsorption regardless of the etiology
boolean
C3714745 (UMLS CUI [1,1])
C0521362 (UMLS CUI [1,2])
Allergy to tomato | Allergic Reaction lycopene
Item
have known allergic reaction to tomato or lycopene
boolean
C1623747 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0065331 (UMLS CUI [2,2])
Study Subject Participation Status
Item
patients who are participating or will participate in other clinical trials
boolean
C2348568 (UMLS CUI [1])
Urinary tract infection
Item
patients who have active urinary tract infection can not be accrued until infection is effectively controlled
boolean
C0042029 (UMLS CUI [1])
Age
Item
patient's age is less than 18 years
boolean
C0001779 (UMLS CUI [1])
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