ID

22693

Beschrijving

Brachytherapy for Prostatic Carcinoma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00525720

Link

https://clinicaltrials.gov/show/NCT00525720

Trefwoorden

Versies (1)
  1. 09-06-17 09-06-17 -
Geüploaded op

9 juni 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00525720

Engels

Eligibility Prostate Cancer NCT00525720

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed adenocarcinoma of the prostate, clinical stage t1c - t2b (ajcc 6th edition), n0, m0. lymph node evaluation by either ct or mri.
Beschrijving

Adenocarcinoma of prostate TNM clinical staging | Lymph nodes Evaluation X-Ray Computed Tomography | Lymph nodes Evaluation Magnetic Resonance Imaging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0024204
UMLS CUI [3,2]
C1261322
UMLS CUI [3,3]
C0024485
2. zubrod performance status 0-1.
Beschrijving

Zubrod Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C3714786
3. patient must be greater than or equal to 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
4. patients with intermediate risk prostate cancer as determined by one of the following combinations: gleason < 7, psa 10-15; gleason 7, psa must be < 10.
Beschrijving

Prostate carcinoma Intermediate Risk | Gleason score | Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3640764
UMLS CUI [2]
C3203027
UMLS CUI [3]
C0201544
5. prostate specific antigen (psa) prior to study entry must be less than or equal to 15 ng/ml.
Beschrijving

Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
6. hormone naive.
Beschrijving

Hormone Therapy naive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0919936
7. prostate volumes by trus less than or equal to 60 cc.
Beschrijving

Prostate volume Transrectal ultrasound

Datatype

boolean

Alias
UMLS CUI [1,1]
C1441416
UMLS CUI [1,2]
C0373345
8. aua voiding symptom scores </= 15 (alpha blockers allowed); this is completed by the patient.
Beschrijving

American Urological Association Symptom Score Voiding | Adrenergic alpha-Antagonists

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831551
UMLS CUI [1,2]
C0042034
UMLS CUI [2]
C0001641
9. patients must sign a study-specific informed consent form prior to study entry.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. stage < t1c, t2c, t3 or t4 disease (ajcc 6th edition).
Beschrijving

Disease TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
2. lymph node involvement (n1).
Beschrijving

Lymph Node Involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0806692
3. evidence of distant metastases (m1).
Beschrijving

Distant metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C1269798
4. radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior turp, prior cryosurgery, tuna, tumt of the prostate.
Beschrijving

Operative Surgical Procedures Radical Prostate carcinoma | Radiotherapy to pelvis | Chemotherapy Prostate carcinoma | Transurethral Resection of Prostate | Cryosurgery | Transurethral Needle Ablation of Prostate | Transurethral microwave thermotherapy (TUMT) of prostate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0439807
UMLS CUI [1,3]
C0600139
UMLS CUI [2]
C1536155
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600139
UMLS CUI [4]
C0040771
UMLS CUI [5]
C0010408
UMLS CUI [6]
C1138404
UMLS CUI [7]
C0994576
5. active prostatitis.
Beschrijving

Prostatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0033581
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Similar models

Eligibility Prostate Cancer NCT00525720

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate TNM clinical staging | Lymph nodes Evaluation X-Ray Computed Tomography | Lymph nodes Evaluation Magnetic Resonance Imaging
Item
1. histologically confirmed adenocarcinoma of the prostate, clinical stage t1c - t2b (ajcc 6th edition), n0, m0. lymph node evaluation by either ct or mri.
boolean
C0007112 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0024204 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
Zubrod Performance Status
Item
2. zubrod performance status 0-1.
boolean
C3714786 (UMLS CUI [1])
Age
Item
3. patient must be greater than or equal to 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Prostate carcinoma Intermediate Risk | Gleason score | Prostate specific antigen measurement
Item
4. patients with intermediate risk prostate cancer as determined by one of the following combinations: gleason < 7, psa 10-15; gleason 7, psa must be < 10.
boolean
C0600139 (UMLS CUI [1,1])
C3640764 (UMLS CUI [1,2])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
Prostate specific antigen measurement
Item
5. prostate specific antigen (psa) prior to study entry must be less than or equal to 15 ng/ml.
boolean
C0201544 (UMLS CUI [1])
Hormone Therapy naive
Item
6. hormone naive.
boolean
C0279025 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Prostate volume Transrectal ultrasound
Item
7. prostate volumes by trus less than or equal to 60 cc.
boolean
C1441416 (UMLS CUI [1,1])
C0373345 (UMLS CUI [1,2])
American Urological Association Symptom Score Voiding | Adrenergic alpha-Antagonists
Item
8. aua voiding symptom scores </= 15 (alpha blockers allowed); this is completed by the patient.
boolean
C3831551 (UMLS CUI [1,1])
C0042034 (UMLS CUI [1,2])
C0001641 (UMLS CUI [2])
Informed Consent
Item
9. patients must sign a study-specific informed consent form prior to study entry.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease TNM clinical staging
Item
1. stage < t1c, t2c, t3 or t4 disease (ajcc 6th edition).
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Lymph Node Involvement
Item
2. lymph node involvement (n1).
boolean
C0806692 (UMLS CUI [1])
Distant metastasis
Item
3. evidence of distant metastases (m1).
boolean
C1269798 (UMLS CUI [1])
Operative Surgical Procedures Radical Prostate carcinoma | Radiotherapy to pelvis | Chemotherapy Prostate carcinoma | Transurethral Resection of Prostate | Cryosurgery | Transurethral Needle Ablation of Prostate | Transurethral microwave thermotherapy (TUMT) of prostate
Item
4. radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior turp, prior cryosurgery, tuna, tumt of the prostate.
boolean
C0543467 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C1536155 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
C0040771 (UMLS CUI [4])
C0010408 (UMLS CUI [5])
C1138404 (UMLS CUI [6])
C0994576 (UMLS CUI [7])
Prostatitis
Item
5. active prostatitis.
boolean
C0033581 (UMLS CUI [1])
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