ID

31595

Description

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

Keywords

Versions (1)
  1. 9/10/18 9/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00773318

English

Eligibility Prostate Cancer NCT00773318

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically proven prostate cancer
Description

Prostate carcinoma

Data type

boolean

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

TNM clinical staging | Bone scan | CT | MRI

Data type

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)
Description

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

Data type

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
Description

Prostate carcinoma | Prostatectomy Scheduled | Pelvic lymphadenectomy Scheduled

Data type

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
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Prostate carcinoma Absent

Data type

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)
Description

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

Data type

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
Description

Secondary malignant neoplasm of lymph node regional

Data type

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
Description

Absence Radical prostatectomy Scheduled | Absence Pelvic lymphadenectomy Scheduled

Data type

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
Description

Medical contraindication Physical | Medical contraindication Psychological

Data type

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
Description

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

Data type

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
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Similar models

Eligibility Prostate Cancer NCT00773318

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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