ID

24037

Description

Responsible Party: Johann J. Wendler, MD, Dr. med., University of Magdeburg ClinicalTrials.gov Identifier: NCT01967407 History of Changes Other Study ID Numbers: DE-UKMD-URO-001 DRKS00004266 ( Other Identifier: DRKS (German Clinical Trials Registry) ) U1111-1140-0415 ( Other Identifier: Universal Trial Number (UTN) ) DRKS00004266 ( Other Identifier: Internat. Clinical Trials Registry Platform ICTRP, WHO ) EUDAMED-No.: CIV-12-04-006021 ( Other Identifier: BfArM, German Federal Inst. for Drugs & Medical Devices ) 00020520 ( Other Identifier: DIMDI, German Inst. for Med. Documentation & Information ) Study First Received: October 15, 2013 Last Updated: November 18, 2014

Keywords

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  1. 7/23/17 7/23/17 -
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Eligibility Kidney Tumor NCT01967407 DRKS00004266

English

Eligibility Kidney Tumor NCT01967407 DRKS00004266

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
One or more localized, resectable kidney tumors (≤4 cm) suspicious of malignancy or histology -proven renal cell cancer (RCC)
Description

Kidney Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0022665
Patients desire for therapy and surgical therapy
Description

Therapy Need

Data type

boolean

Alias
UMLS CUI [1]
C1830593
Karnofsky-index >70%
Description

Karnofsky-index

Data type

boolean

Alias
UMLS CUI [1]
C0206065
Age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Life expectancy ≥ 12 month
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Compliance of the patient taking part in a study
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Violation against one or more inclusion criteria
Description

Protocol Violation

Data type

boolean

Alias
UMLS CUI [1]
C1709750
Cardial pacemaker or other electrical implants
Description

Electrical Implants

Data type

boolean

Alias
UMLS CUI [1,1]
C0442828
UMLS CUI [1,2]
C0021102
QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
Description

Cardiac arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
Known cardial ejection fraction < 30% or NYHA III or III-IV
Description

Cardial ejection fraction, NYHA

Data type

boolean

Alias
UMLS CUI [1]
C0042508
UMLS CUI [2]
C1275491
Known epilepsy
Description

Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0014544
Second malignancy (except basal-cell carcinoma and cervical carcinoma in situ)
Description

Second malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0085183
Immunosuppression or HIV-positive patients
Description

Immunosuppression or HIV-positive patients

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0019682
Active infection or severe health interference, that make taking part in a study unfeasible
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Pregnancy, lactation period, no contraception
Description

Gynaecological Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
Metastatic disease
Description

Metastatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0027627
Palliative status
Description

Palliative status

Data type

boolean

Alias
UMLS CUI [1]
C1285530
Running or executed RCC therapy
Description

RCC therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0087111
Taking part in another clinical study for RCC
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Inoperable
Description

Inoperable

Data type

boolean

Alias
UMLS CUI [1]
C0205187
Rejection of interventional or surgical therapy by the patient
Description

Rejection

Data type

boolean

Alias
UMLS CUI [1]
C1548437
Circulatory instability
Description

Circulatory instability

Data type

boolean

Alias
UMLS CUI [1]
C0549406
General contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
Description

Contraindication to aneshtesia

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002903
Psychiatric disorders that make taking part in a study or giving informed consent unfeasible
Description

Mental Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004936
Haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
Description

Bleeding Disorder

Data type

text

Alias
UMLS CUI [1]
C0005779
Thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time >50
Description

Thromboplastin time, thrombocytes, PTT

Data type

boolean

Alias
UMLS CUI [1]
C0858243
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0030605
MRI incompatibility
Description

MRI incompatibility

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0679426
Metal implants <1 cm closed to the kidney / kidney tumor
Description

Metal implants

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0025552
Contraindication for biopsy and punction of the renal tumor under CT-guidance
Description

Contraindication for biopsy and puncture

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0034117
Untreated urinary retention
Description

Urinary retention

Data type

boolean

Alias
UMLS CUI [1]
C0080274
Renal pelvis tumor, suspected transitional cell cancer
Description

Tumor Site, Tumor Histology

Data type

boolean

Alias
UMLS CUI [1]
C0475445
UMLS CUI [2,1]
C0019638
UMLS CUI [2,2]
C0006826
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
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Similar models

Eligibility Kidney Tumor NCT01967407 DRKS00004266

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Kidney Neoplasm
Item
One or more localized, resectable kidney tumors (≤4 cm) suspicious of malignancy or histology -proven renal cell cancer (RCC)
boolean
C0022665 (UMLS CUI [1])
Therapy Need
Item
Patients desire for therapy and surgical therapy
boolean
C1830593 (UMLS CUI [1])
Karnofsky-index
Item
Karnofsky-index >70%
boolean
C0206065 (UMLS CUI [1])
Age
Item
Age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Life expectancy
Item
Life expectancy ≥ 12 month
boolean
C0023671 (UMLS CUI [1])
Compliance
Item
Compliance of the patient taking part in a study
boolean
C1321605 (UMLS CUI [1])
Informed consent
Item
Informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Protocol Violation
Item
Violation against one or more inclusion criteria
boolean
C1709750 (UMLS CUI [1])
Electrical Implants
Item
Cardial pacemaker or other electrical implants
boolean
C0442828 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Cardiac arrhythmia
Item
QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
boolean
C0003811 (UMLS CUI [1])
Cardial ejection fraction, NYHA
Item
Known cardial ejection fraction < 30% or NYHA III or III-IV
boolean
C0042508 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Epilepsy
Item
Known epilepsy
boolean
C0014544 (UMLS CUI [1])
Second malignancy
Item
Second malignancy (except basal-cell carcinoma and cervical carcinoma in situ)
boolean
C0085183 (UMLS CUI [1])
Immunosuppression or HIV-positive patients
Item
Immunosuppression or HIV-positive patients
boolean
C0021079 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
Comorbidity
Item
Active infection or severe health interference, that make taking part in a study unfeasible
boolean
C0009488 (UMLS CUI [1])
Gynaecological Status
Item
Pregnancy, lactation period, no contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Metastatic disease
Item
Metastatic disease
boolean
C0027627 (UMLS CUI [1])
Palliative status
Item
Palliative status
boolean
C1285530 (UMLS CUI [1])
RCC therapy
Item
Running or executed RCC therapy
boolean
C0007134 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Study Participation Status
Item
Taking part in another clinical study for RCC
boolean
C2348568 (UMLS CUI [1])
Inoperable
Item
Inoperable
boolean
C0205187 (UMLS CUI [1])
Rejection
Item
Rejection of interventional or surgical therapy by the patient
boolean
C1548437 (UMLS CUI [1])
Circulatory instability
Item
Circulatory instability
boolean
C0549406 (UMLS CUI [1])
Contraindication to aneshtesia
Item
General contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
boolean
C1301624 (UMLS CUI [1,1])
C0002903 (UMLS CUI [1,2])
Mental Disorder
Item
Psychiatric disorders that make taking part in a study or giving informed consent unfeasible
boolean
C0004936 (UMLS CUI [1])
Bleeding Disorder
Item
Haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
text
C0005779 (UMLS CUI [1])
Thromboplastin time, thrombocytes, PTT
Item
Thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time >50
boolean
C0858243 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
MRI incompatibility
Item
MRI incompatibility
boolean
C0024485 (UMLS CUI [1,1])
C0679426 (UMLS CUI [1,2])
Metal implants
Item
Metal implants <1 cm closed to the kidney / kidney tumor
boolean
C0021102 (UMLS CUI [1,1])
C0025552 (UMLS CUI [1,2])
Contraindication for biopsy and puncture
Item
Contraindication for biopsy and punction of the renal tumor under CT-guidance
boolean
C1301624 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0034117 (UMLS CUI [2,2])
Urinary retention
Item
Untreated urinary retention
boolean
C0080274 (UMLS CUI [1])
Tumor Site, Tumor Histology
Item
Renal pelvis tumor, suspected transitional cell cancer
boolean
C0475445 (UMLS CUI [1])
C0019638 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
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