ID

22704

Beschreibung

Preoperative Radiation Therapy for High Risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01041326

Link

https://clinicaltrials.gov/show/NCT01041326

Stichworte

Versionen (1)
  1. 10.06.17 10.06.17 -
Hochgeladen am

10. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01041326

Englisch

Eligibility Prostate Cancer NCT01041326

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
biopsy-confirmed "high-risk" prostate cancer, defined as a. psa > 20, b. gleason score (gs) >/= 8, and/or c. clinical stage t3 disease per ajcc staging manual, 6th edition; or d. at least two out of three of the following: psa 10-19.9, gs = 7, or clinical stage = t2b / t2c.
Beschreibung

Prostate carcinoma High risk Biopsy | Prostate specific antigen measurement | Gleason score | TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0005558
UMLS CUI [2]
C0201544
UMLS CUI [3]
C3203027
UMLS CUI [4]
C3258246
a negative bone scan,
Beschreibung

Bone scan Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0203668
UMLS CUI [1,2]
C1513916
be medically fit to undergo surgery as determined by treating urologist,
Beschreibung

Fit and well | Operative Surgical Procedures Receive Ability

Datentyp

boolean

Alias
UMLS CUI [1]
C0424576
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0085732
age > 18,
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
kps must be >/= 80,
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
no prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
Beschreibung

Radiotherapy to pelvis Absent | Chemotherapy Absent | Antiandrogen therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1536155
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0279492
UMLS CUI [3,2]
C0332197
no prior invasive malignancy, except non- melanomatous skin cancer unless disease free for a minimum of 5 years. carcinoma in-situ of the bladder or head and neck region is permissible.
Beschreibung

Invasive cancer Absent | Skin carcinoma | Disease Free of | Carcinoma in situ of bladder | Carcinoma in Situ Head and neck

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0699893
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332296
UMLS CUI [4]
C0154091
UMLS CUI [5,1]
C0007099
UMLS CUI [5,2]
C0460004
subjects must freely sign informed consent to enroll in the study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
Beschreibung

Radiotherapy to pelvis | Chemotherapy | Antiandrogen therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1536155
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279492
prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 5 years.
Beschreibung

Invasive cancer | Skin carcinoma | Carcinoma in situ of bladder | Carcinoma in Situ Head and neck | Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0154091
UMLS CUI [4,1]
C0007099
UMLS CUI [4,2]
C0460004
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332296
metastatic disease as demonstrated by bone scan, ct scan or mri of the pelvis, or chest x-ray.
Beschreibung

Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT scan | Neoplasm Metastasis MRI of Pelvis | Neoplasm Metastasis Plain chest X-ray

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0203201
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0039985
pathologically documented positive pelvic lymph nodes. if pre-operative ct scan or mri (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
Beschreibung

Pelvic lymph nodes Positive | CT scan Preoperative | MRI Preoperative | Lymph Node Involvement Suspected | Biopsy Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729595
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0040405
UMLS CUI [2,2]
C0445204
UMLS CUI [3,1]
C0024485
UMLS CUI [3,2]
C0445204
UMLS CUI [4,1]
C0806692
UMLS CUI [4,2]
C0750491
UMLS CUI [5,1]
C0005558
UMLS CUI [5,2]
C0686904
declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
Beschreibung

Anesthesia High risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002903
UMLS CUI [1,2]
C0332167
history of prior pelvic radiation therapy.
Beschreibung

Radiotherapy to pelvis

Datentyp

boolean

Alias
UMLS CUI [1]
C1536155
history of androgen deprivation therapy or chemotherapy.
Beschreibung

Antiandrogen therapy | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C0392920
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Ähnliche Modelle

Eligibility Prostate Cancer NCT01041326

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
subjects must have
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Prostate carcinoma High risk Biopsy | Prostate specific antigen measurement | Gleason score | TNM clinical staging
Item
biopsy-confirmed "high-risk" prostate cancer, defined as a. psa > 20, b. gleason score (gs) >/= 8, and/or c. clinical stage t3 disease per ajcc staging manual, 6th edition; or d. at least two out of three of the following: psa 10-19.9, gs = 7, or clinical stage = t2b / t2c.
boolean
C0600139 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0201544 (UMLS CUI [2])
C3203027 (UMLS CUI [3])
C3258246 (UMLS CUI [4])
Bone scan Negative
Item
a negative bone scan,
boolean
C0203668 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Fit and well | Operative Surgical Procedures Receive Ability
Item
be medically fit to undergo surgery as determined by treating urologist,
boolean
C0424576 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Age
Item
age > 18,
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
kps must be >/= 80,
boolean
C0206065 (UMLS CUI [1])
Radiotherapy to pelvis Absent | Chemotherapy Absent | Antiandrogen therapy Absent
Item
no prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
boolean
C1536155 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279492 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Invasive cancer Absent | Skin carcinoma | Disease Free of | Carcinoma in situ of bladder | Carcinoma in Situ Head and neck
Item
no prior invasive malignancy, except non- melanomatous skin cancer unless disease free for a minimum of 5 years. carcinoma in-situ of the bladder or head and neck region is permissible.
boolean
C0677898 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0154091 (UMLS CUI [4])
C0007099 (UMLS CUI [5,1])
C0460004 (UMLS CUI [5,2])
Informed Consent
Item
subjects must freely sign informed consent to enroll in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to pelvis | Chemotherapy | Antiandrogen therapy
Item
prior pelvic radiation therapy, chemotherapy, or androgen deprivation,
boolean
C1536155 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279492 (UMLS CUI [3])
Invasive cancer | Skin carcinoma | Carcinoma in situ of bladder | Carcinoma in Situ Head and neck | Disease Free of
Item
prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 5 years.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0154091 (UMLS CUI [3])
C0007099 (UMLS CUI [4,1])
C0460004 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT scan | Neoplasm Metastasis MRI of Pelvis | Neoplasm Metastasis Plain chest X-ray
Item
metastatic disease as demonstrated by bone scan, ct scan or mri of the pelvis, or chest x-ray.
boolean
C0027627 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0203201 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C0039985 (UMLS CUI [4,2])
Pelvic lymph nodes Positive | CT scan Preoperative | MRI Preoperative | Lymph Node Involvement Suspected | Biopsy Patient need for
Item
pathologically documented positive pelvic lymph nodes. if pre-operative ct scan or mri (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
boolean
C0729595 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C0024485 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
C0806692 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0005558 (UMLS CUI [5,1])
C0686904 (UMLS CUI [5,2])
Anesthesia High risk
Item
declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
boolean
C0002903 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
Radiotherapy to pelvis
Item
history of prior pelvic radiation therapy.
boolean
C1536155 (UMLS CUI [1])
Antiandrogen therapy | Chemotherapy
Item
history of androgen deprivation therapy or chemotherapy.
boolean
C0279492 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
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