ID

31595

Beschrijving

SPECT-CT Guided Lymphatic Mapping and Sentinel Lymphadenectomy (LM/SL) in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00773318

Link

https://clinicaltrials.gov/show/NCT00773318

Trefwoorden

  1. 10-09-18 10-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 september 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00773318

Eligibility Prostate Cancer NCT00773318

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically proven prostate cancer
Beschrijving

Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0600139
initial staging (bone scan, ct, or mri) according to the nccn guidelines
Beschrijving

TNM clinical staging | Bone scan | CT | MRI

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C0203668
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0024485
patients with ajcc stages i - ii - iii prostate cancer including men with clinical t3n0m0 disease, men with psa > 10 mg/ml, and men with gleason score of 8-10 (high grade disease)
Beschrijving

Prostate carcinoma TNM clinical staging | Gender | Disease TNM clinical staging | Prostate specific antigen measurement | Disease High grade Gleason score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C3258246
UMLS CUI [4]
C0201544
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C3203027
prostate cancer patients will be scheduled for prostatectomy and pelvic lymph node dissection
Beschrijving

Prostate carcinoma | Prostatectomy Scheduled | Pelvic lymphadenectomy Scheduled

Datatype

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C0033573
UMLS CUI [2,2]
C0205539
UMLS CUI [3,1]
C0193883
UMLS CUI [3,2]
C0205539
informed consent signed by the patient
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with no histological evidence of prostate cancer
Beschrijving

Prostate carcinoma Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0332197
patient with regionally advanced disease or metastatic disease (t4, and/or n1, and/or m1)
Beschrijving

Advanced disease regional TNM clinical staging | Neoplasm Metastasis TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C0205147
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C3258246
patients with clinically and/or radiologically evident regional lymph node metastases
Beschrijving

Secondary malignant neoplasm of lymph node regional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686619
UMLS CUI [1,2]
C0205147
patients who are not scheduled for radical prostatectomy and pelvic lymph node dissection
Beschrijving

Absence Radical prostatectomy Scheduled | Absence Pelvic lymphadenectomy Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0194810
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0193883
UMLS CUI [2,3]
C0205539
patients with physical and/or psychological contraindications
Beschrijving

Medical contraindication Physical | Medical contraindication Psychological

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0205485
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0205486
recent studies in nuclear medicine with long half-time isotopes (i.e. t ½ > 48h; 111in, 67ga, 201tl, 131i) performed within 1 week preceding the lm/sl
Beschrijving

Nuclear Medicine (radioisotope study) | Other Coding | Indium-111 | Gallium-67 | Thallium-201 | iodine I-131

Datatype

boolean

Alias
UMLS CUI [1]
C1547109
UMLS CUI [2]
C3846158
UMLS CUI [3]
C0303403
UMLS CUI [4]
C0303225
UMLS CUI [5]
C0303322
UMLS CUI [6]
C0303029

Similar models

Eligibility Prostate Cancer NCT00773318

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma
Item
patients with histologically proven prostate cancer
boolean
C0600139 (UMLS CUI [1])
TNM clinical staging | Bone scan | CT | MRI
Item
initial staging (bone scan, ct, or mri) according to the nccn guidelines
boolean
C3258246 (UMLS CUI [1])
C0203668 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
Prostate carcinoma TNM clinical staging | Gender | Disease TNM clinical staging | Prostate specific antigen measurement | Disease High grade Gleason score
Item
patients with ajcc stages i - ii - iii prostate cancer including men with clinical t3n0m0 disease, men with psa > 10 mg/ml, and men with gleason score of 8-10 (high grade disease)
boolean
C0600139 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0201544 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C3203027 (UMLS CUI [5,3])
Prostate carcinoma | Prostatectomy Scheduled | Pelvic lymphadenectomy Scheduled
Item
prostate cancer patients will be scheduled for prostatectomy and pelvic lymph node dissection
boolean
C0600139 (UMLS CUI [1])
C0033573 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0193883 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
Informed Consent
Item
informed consent signed by the patient
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prostate carcinoma Absent
Item
patients with no histological evidence of prostate cancer
boolean
C0600139 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Advanced disease regional TNM clinical staging | Neoplasm Metastasis TNM clinical staging
Item
patient with regionally advanced disease or metastatic disease (t4, and/or n1, and/or m1)
boolean
C0679246 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Secondary malignant neoplasm of lymph node regional
Item
patients with clinically and/or radiologically evident regional lymph node metastases
boolean
C0686619 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
Absence Radical prostatectomy Scheduled | Absence Pelvic lymphadenectomy Scheduled
Item
patients who are not scheduled for radical prostatectomy and pelvic lymph node dissection
boolean
C0332197 (UMLS CUI [1,1])
C0194810 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0193883 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
Medical contraindication Physical | Medical contraindication Psychological
Item
patients with physical and/or psychological contraindications
boolean
C1301624 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0205486 (UMLS CUI [2,2])
Nuclear Medicine (radioisotope study) | Other Coding | Indium-111 | Gallium-67 | Thallium-201 | iodine I-131
Item
recent studies in nuclear medicine with long half-time isotopes (i.e. t ½ > 48h; 111in, 67ga, 201tl, 131i) performed within 1 week preceding the lm/sl
boolean
C1547109 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C0303403 (UMLS CUI [3])
C0303225 (UMLS CUI [4])
C0303322 (UMLS CUI [5])
C0303029 (UMLS CUI [6])

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