ID

31677

Description

Prostate Active Surveillance Study; ODM derived from: https://clinicaltrials.gov/show/NCT00756665

Lien

https://clinicaltrials.gov/show/NCT00756665

Mots-clés

Versions (1)
  1. 20/09/2018 20/09/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

20 septembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Prostatic Neoplasms NCT00756665

Anglais

Eligibility Prostatic Neoplasms NCT00756665

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate.
Description

Adenocarcinoma of prostate

Type de données

boolean

Alias
UMLS CUI [1]
C0007112
clinically localized prostate cancer: t1-2, nx or n0, mx or m0.
Description

Prostate carcinoma Localized TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0392752
UMLS CUI [1,3]
C3258246
no previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
Description

Absence Prior Therapy Prostate carcinoma | Prior Hormone Therapy Absent | Prior radiation therapy Absent | Operative Surgical Procedures Absent | Prior Chemotherapy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1514457
UMLS CUI [5,2]
C0332197
ecog performance status 0 or 1.
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
patient has elected active surveillance as preferred management plan for prostate cancer.
Description

Election Surveillance Prostate carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1707391
UMLS CUI [1,2]
C0733511
UMLS CUI [1,3]
C0600139
patient consent has been obtained according to local institutional review board for acquisition of research specimens.
Description

Consent Acquisition Research Specimen

Type de données

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C1706701
UMLS CUI [1,3]
C0370003
patient is accessible and compliant for follow-up.
Description

Patient Available Follow-up | Compliance behavior Follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
prostate biopsy requirements:
Description

Biopsy of prostate Criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C0243161
1. if diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
Description

Biopsy Quantity | Core needle biopsy Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1318309
UMLS CUI [2,2]
C1265611
2. if diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit.
Description

Prior diagnosis | Biopsy Quantity Minimum

Type de données

boolean

Alias
UMLS CUI [1]
C0332132
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1524031
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unwillingness or inability to undergo serial prostate biopsy.
Description

Series Biopsy of prostate Unwilling | Series Biopsy of prostate Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205549
UMLS CUI [1,2]
C0194804
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0205549
UMLS CUI [2,2]
C0194804
UMLS CUI [2,3]
C1299582
history of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (ta) or other solid tumors curatively treated with no evidence of disease for > 5 years.
Description

Cancer Other | Exception Skin carcinoma Treated | Exception Superficial bladder cancer Treated | Exception Curative treatment Solid Neoplasm | Exception Disease Free of

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1336527
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0280100
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
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Similar models

Eligibility Prostatic Neoplasms NCT00756665

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Prostate carcinoma Localized TNM clinical staging
Item
clinically localized prostate cancer: t1-2, nx or n0, mx or m0.
boolean
C0600139 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Absence Prior Therapy Prostate carcinoma | Prior Hormone Therapy Absent | Prior radiation therapy Absent | Operative Surgical Procedures Absent | Prior Chemotherapy Absent
Item
no previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
boolean
C0332197 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C1514460 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1514457 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
ECOG performance status
Item
ecog performance status 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Election Surveillance Prostate carcinoma
Item
patient has elected active surveillance as preferred management plan for prostate cancer.
boolean
C1707391 (UMLS CUI [1,1])
C0733511 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Consent Acquisition Research Specimen
Item
patient consent has been obtained according to local institutional review board for acquisition of research specimens.
boolean
C1511481 (UMLS CUI [1,1])
C1706701 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
Patient Available Follow-up | Compliance behavior Follow-up
Item
patient is accessible and compliant for follow-up.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Biopsy of prostate Criteria
Item
prostate biopsy requirements:
boolean
C0194804 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Biopsy Quantity | Core needle biopsy Quantity
Item
1. if diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
boolean
C0005558 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1318309 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Prior diagnosis | Biopsy Quantity Minimum
Item
2. if diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit.
boolean
C0332132 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Series Biopsy of prostate Unwilling | Series Biopsy of prostate Unable
Item
unwillingness or inability to undergo serial prostate biopsy.
boolean
C0205549 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0205549 (UMLS CUI [2,1])
C0194804 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Cancer Other | Exception Skin carcinoma Treated | Exception Superficial bladder cancer Treated | Exception Curative treatment Solid Neoplasm | Exception Disease Free of
Item
history of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (ta) or other solid tumors curatively treated with no evidence of disease for > 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1336527 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0280100 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
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