ID

22537

Description

Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.; ODM derived from: https://clinicaltrials.gov/show/NCT00258765

Lien

https://clinicaltrials.gov/show/NCT00258765

Mots-clés

Versions (1)
  1. 07/06/2017 07/06/2017 -
Téléchargé le

7 juin 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00258765

Anglais

Eligibility Prostate Cancer NCT00258765

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
radical prostatectomy for prostate cancer within last 2 months.
Description

Radical prostatectomy Prostate carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C0600139
post-operative kattan nomogram predicts >25% risk of psa relapse by 5 years.
Description

Nomogram Postoperative | Risk Percentage Prostate-Specific Antigen Relapse

Type de données

boolean

Alias
UMLS CUI [1,1]
C1450294
UMLS CUI [1,2]
C0032790
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0138741
UMLS CUI [2,4]
C0035020
6-week post-operative serum psa<0.2ng/ml.
Description

Prostate specific antigen measurement Postoperative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0032790
low levels of circulating prostate cancer cells in the blood, detected by pcr amplification of psa mrna 6 weeks post-prostatectomy.
Description

Prostate carcinoma Circulating Neoplastic Cells low | Polymerase Chain Reaction Amplification Prostate-Specific Antigen mRNA | Prostatectomy Status post

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0027625
UMLS CUI [1,3]
C0205251
UMLS CUI [2,1]
C0032520
UMLS CUI [2,2]
C1521871
UMLS CUI [2,3]
C0138741
UMLS CUI [2,4]
C0035696
UMLS CUI [3,1]
C0033573
UMLS CUI [3,2]
C0231290
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-operative serum psa level >20ng/ml.
Description

Prostate specific antigen measurement Preoperative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0445204
clinical evidence of metastases by 6-week post-operative visit.
Description

Neoplasm Metastasis Evidence of

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
prior treatment with either adt or bisphosphonate therapy.
Description

Antiandrogen therapy | Diphosphonates

Type de données

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C0012544
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
Description

Tooth problem | Infection of tooth | infection; jaw | maxilla; infection | Mandible Communicable Disease | Dental trauma | necrosis; bone, jaw | Oral cavity Bone Exposed | Dental Procedures Healing Slow

Type de données

boolean

Alias
UMLS CUI [1]
C0576962
UMLS CUI [2]
C0877046
UMLS CUI [3]
C1400570
UMLS CUI [4]
C1400602
UMLS CUI [5,1]
C0024687
UMLS CUI [5,2]
C0009450
UMLS CUI [6]
C1301685
UMLS CUI [7]
C1390494
UMLS CUI [8,1]
C0226896
UMLS CUI [8,2]
C0262950
UMLS CUI [8,3]
C0332157
UMLS CUI [9,1]
C0011331
UMLS CUI [9,2]
C0043240
UMLS CUI [9,3]
C0439834
recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)
Description

Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implant

Type de données

boolean

Alias
UMLS CUI [1]
C0204324
UMLS CUI [2]
C0407713
UMLS CUI [3]
C0040440
UMLS CUI [4]
C0011370
other protocol defined inclusion / exclusion criteria may apply.
Description

Clinical Trial Eligibility Criteria Additional

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Prostate Cancer NCT00258765

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Radical prostatectomy Prostate carcinoma
Item
radical prostatectomy for prostate cancer within last 2 months.
boolean
C0194810 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Nomogram Postoperative | Risk Percentage Prostate-Specific Antigen Relapse
Item
post-operative kattan nomogram predicts >25% risk of psa relapse by 5 years.
boolean
C1450294 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C0035647 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0138741 (UMLS CUI [2,3])
C0035020 (UMLS CUI [2,4])
Prostate specific antigen measurement Postoperative
Item
6-week post-operative serum psa<0.2ng/ml.
boolean
C0201544 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
Prostate carcinoma Circulating Neoplastic Cells low | Polymerase Chain Reaction Amplification Prostate-Specific Antigen mRNA | Prostatectomy Status post
Item
low levels of circulating prostate cancer cells in the blood, detected by pcr amplification of psa mrna 6 weeks post-prostatectomy.
boolean
C0600139 (UMLS CUI [1,1])
C0027625 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0032520 (UMLS CUI [2,1])
C1521871 (UMLS CUI [2,2])
C0138741 (UMLS CUI [2,3])
C0035696 (UMLS CUI [2,4])
C0033573 (UMLS CUI [3,1])
C0231290 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Prostate specific antigen measurement Preoperative
Item
pre-operative serum psa level >20ng/ml.
boolean
C0201544 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Neoplasm Metastasis Evidence of
Item
clinical evidence of metastases by 6-week post-operative visit.
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Antiandrogen therapy | Diphosphonates
Item
prior treatment with either adt or bisphosphonate therapy.
boolean
C0279492 (UMLS CUI [1])
C0012544 (UMLS CUI [2])
Tooth problem | Infection of tooth | infection; jaw | maxilla; infection | Mandible Communicable Disease | Dental trauma | necrosis; bone, jaw | Oral cavity Bone Exposed | Dental Procedures Healing Slow
Item
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
boolean
C0576962 (UMLS CUI [1])
C0877046 (UMLS CUI [2])
C1400570 (UMLS CUI [3])
C1400602 (UMLS CUI [4])
C0024687 (UMLS CUI [5,1])
C0009450 (UMLS CUI [5,2])
C1301685 (UMLS CUI [6])
C1390494 (UMLS CUI [7])
C0226896 (UMLS CUI [8,1])
C0262950 (UMLS CUI [8,2])
C0332157 (UMLS CUI [8,3])
C0011331 (UMLS CUI [9,1])
C0043240 (UMLS CUI [9,2])
C0439834 (UMLS CUI [9,3])
Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implant
Item
recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)
boolean
C0204324 (UMLS CUI [1])
C0407713 (UMLS CUI [2])
C0040440 (UMLS CUI [3])
C0011370 (UMLS CUI [4])
Clinical Trial Eligibility Criteria Additional
Item
other protocol defined inclusion / exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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