ID

23193

Description

Responsible Party: Association of Urogenital Oncology (AUO) ClinicalTrials.gov Identifier: NCT01555086 History of Changes Other Study ID Numbers: AP 55/09 DRKS00003256 ( Registry Identifier: DRKS ) Study First Received: March 13, 2012 Last Updated: January 23, 2017 Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT01555086

Link

https://clinicaltrials.gov/show/NCT01555086

Keywords

Versions (1)
  1. 6/27/17 6/27/17 -
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June 27, 2017

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer DRKS00003256 NCT01555086 DRKS00003256

English

Eligibility Prostate Cancer NCT01555086 DRKS00003256

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as gleason-score 7-10 or psa > 10 ng/ml)
Description

Prostate Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0194804
Locally-operable tumor according to dru/trus
Description

Operability

Data type

boolean

Alias
UMLS CUI [1]
C0205188
Negative bone scan
Description

Bone Scan

Data type

boolean

Alias
UMLS CUI [1]
C0203668
Negative ct abdomen / pelvis
Description

CT abdomen / pelvis

Data type

boolean

Alias
UMLS CUI [1]
C0412620
UMLS CUI [2]
C0412628
General condition according to karnofsky >/= 80%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
Written consent of the patient
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Adequate hematological, renal and coagulation physiological functions
Description

Hematological, renal and coagulation physiological functions

Data type

boolean

Alias
UMLS CUI [1]
C0018941
UMLS CUI [2]
C0232804
UMLS CUI [3]
C3516400
Patient compliance and geographic proximity to allow adequate follow-up
Description

Compliance and Residency

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0035182
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Manifest secondary malignancy
Description

Secondary malignancy

Data type

boolean

Alias
UMLS CUI [1]
C3266877
Secured metastasis by histologically or by imaging
Description

Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
Myocardial infarction or stroke within the last 6 months
Description

Myocardial infarction or stroke

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
Existing major cardiovascular (grade iii - iv according to nyha), pulmonary (po2 <60 mmhg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Severe active or chronic infections (eg pos. hiv-ab test, hbs-ag detection in serum and / or chronic hepatitis)
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
Severe psychiatric disease
Description

Mental Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004936
Prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months)
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
Previous pelvic radiotherapy
Description

Pelvic radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0436276
Patients in a closed institution according to an authority or court decision
Description

Institutionalized

Data type

boolean

Alias
UMLS CUI [1]
C0562359
People who are in a dependent relationship or working relationship with the sponsor or investigator
Description

Relationship

Data type

boolean

Alias
UMLS CUI [1]
C0439849
Simultaneous participation in another clinical trial
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Prostate Cancer NCT01555086 DRKS00003256

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate Biopsy
Item
Stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as gleason-score 7-10 or psa > 10 ng/ml)
boolean
C0194804 (UMLS CUI [1])
Operability
Item
Locally-operable tumor according to dru/trus
boolean
C0205188 (UMLS CUI [1])
Bone Scan
Item
Negative bone scan
boolean
C0203668 (UMLS CUI [1])
CT abdomen / pelvis
Item
Negative ct abdomen / pelvis
boolean
C0412620 (UMLS CUI [1])
C0412628 (UMLS CUI [2])
Karnofsky Performance Status
Item
General condition according to karnofsky >/= 80%
boolean
C0206065 (UMLS CUI [1])
Informed Consent
Item
Written consent of the patient
boolean
C0021430 (UMLS CUI [1])
Hematological, renal and coagulation physiological functions
Item
Adequate hematological, renal and coagulation physiological functions
boolean
C0018941 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C3516400 (UMLS CUI [3])
Compliance and Residency
Item
Patient compliance and geographic proximity to allow adequate follow-up
boolean
C1321605 (UMLS CUI [1])
C0035182 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Secondary malignancy
Item
Manifest secondary malignancy
boolean
C3266877 (UMLS CUI [1])
Metastasis
Item
Secured metastasis by histologically or by imaging
boolean
C0027627 (UMLS CUI [1])
Myocardial infarction or stroke
Item
Myocardial infarction or stroke within the last 6 months
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Comorbidity
Item
Existing major cardiovascular (grade iii - iv according to nyha), pulmonary (po2 <60 mmhg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
boolean
C0009488 (UMLS CUI [1])
Infection
Item
Severe active or chronic infections (eg pos. hiv-ab test, hbs-ag detection in serum and / or chronic hepatitis)
boolean
C0009450 (UMLS CUI [1])
Mental Disorder
Item
Severe psychiatric disease
boolean
C0004936 (UMLS CUI [1])
Prior Chemotherapy
Item
Prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months)
boolean
C1514457 (UMLS CUI [1])
Pelvic radiotherapy
Item
Previous pelvic radiotherapy
boolean
C0436276 (UMLS CUI [1])
Institutionalized
Item
Patients in a closed institution according to an authority or court decision
boolean
C0562359 (UMLS CUI [1])
Relationship
Item
People who are in a dependent relationship or working relationship with the sponsor or investigator
boolean
C0439849 (UMLS CUI [1])
Study Participation Status
Item
Simultaneous participation in another clinical trial
boolean
C2348568 (UMLS CUI [1])
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