ID

22702

Beschrijving

Changes in DNA After Radiation Therapy in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00899912

Link

https://clinicaltrials.gov/show/NCT00899912

Trefwoorden

Versies (1)
  1. 10-06-17 10-06-17 -
Geüploaded op

10 juni 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00899912

Engels

Eligibility Prostate Cancer NCT00899912

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed, locally confined adenocarcinoma of the prostate
Beschrijving

Adenocarcinoma of prostate Local

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0205276
zubrod performance 0-1
Beschrijving

Zubrod Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C3714786
clinical stages t1c - t2b, n0, m0
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
combined gleason score 7 if prostate specific antigen (psa) < 10, combined gleason score < 7 if psa 10 - 20; psa must be ≤ 20 ng/ml, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (trus) ≤ 60 cc.
Beschrijving

Gleason score Combined | Prostate specific antigen measurement | Hormone Therapy | Prostate volume Transrectal ultrasound

Datatype

boolean

Alias
UMLS CUI [1,1]
C3203027
UMLS CUI [1,2]
C0205195
UMLS CUI [2]
C0201544
UMLS CUI [3]
C0279025
UMLS CUI [4,1]
C1441416
UMLS CUI [4,2]
C0373345
american urological association (aua) score ≤ 15 (alpha blockers are allowed).
Beschrijving

American Urological Association Symptom Score | Adrenergic alpha-Antagonists

Datatype

boolean

Alias
UMLS CUI [1]
C3831551
UMLS CUI [2]
C0001641
age ≥ 18 years old and must sign a study-specific informed consent form
Beschrijving

Age | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no clinically or pathologically involved lymph nodes
Beschrijving

Lymph Node Involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0806692
no distant metastases or significant obstructive symptoms
Beschrijving

Distant metastasis | OBSTRUCTIVE SYMPTOM

Datatype

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2]
C0746983
no prior chemotherapy, pelvic radiation, transurethral prostatectomy (turp), cryosurgery, tuna, transurethral microwave thermotherapy (tumt) or radical surgery for carcinoma of the prostate is allowed.
Beschrijving

Chemotherapy | Radiotherapy to pelvis | Transurethral Resection of Prostate | Cryosurgery | Transurethral Needle Ablation of Prostate | Transurethral Microwave Thermotherapy | Operative Surgical Procedures Radical Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1536155
UMLS CUI [3]
C0040771
UMLS CUI [4]
C0010408
UMLS CUI [5]
C1138404
UMLS CUI [6]
C1136095
UMLS CUI [7,1]
C0543467
UMLS CUI [7,2]
C0439807
UMLS CUI [7,3]
C0600139
no previous hormonal therapy beginning < 2 months or > 6 months prior to registration is allowed.
Beschrijving

Hormone Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279025
no previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years.
Beschrijving

Malignant Neoplasms | Basal cell carcinoma | Carcinoma in Situ | Squamous cell carcinoma of skin | Disease Free of

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0007099
UMLS CUI [4]
C0553723
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332296
no hip prosthesis or major medical or psychiatric illnesses are allowed. prior to study entry.
Beschrijving

Hip Prosthesis | Illness Major | Mental disorders Major

Datatype

boolean

Alias
UMLS CUI [1]
C0019560
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205164
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205164
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Similar models

Eligibility Prostate Cancer NCT00899912

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate Local
Item
histologically confirmed, locally confined adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Zubrod Performance Status
Item
zubrod performance 0-1
boolean
C3714786 (UMLS CUI [1])
TNM clinical staging
Item
clinical stages t1c - t2b, n0, m0
boolean
C3258246 (UMLS CUI [1])
Gleason score Combined | Prostate specific antigen measurement | Hormone Therapy | Prostate volume Transrectal ultrasound
Item
combined gleason score 7 if prostate specific antigen (psa) < 10, combined gleason score < 7 if psa 10 - 20; psa must be ≤ 20 ng/ml, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (trus) ≤ 60 cc.
boolean
C3203027 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C1441416 (UMLS CUI [4,1])
C0373345 (UMLS CUI [4,2])
American Urological Association Symptom Score | Adrenergic alpha-Antagonists
Item
american urological association (aua) score ≤ 15 (alpha blockers are allowed).
boolean
C3831551 (UMLS CUI [1])
C0001641 (UMLS CUI [2])
Age | Informed Consent
Item
age ≥ 18 years old and must sign a study-specific informed consent form
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Lymph Node Involvement
Item
no clinically or pathologically involved lymph nodes
boolean
C0806692 (UMLS CUI [1])
Distant metastasis | OBSTRUCTIVE SYMPTOM
Item
no distant metastases or significant obstructive symptoms
boolean
C1269798 (UMLS CUI [1])
C0746983 (UMLS CUI [2])
Chemotherapy | Radiotherapy to pelvis | Transurethral Resection of Prostate | Cryosurgery | Transurethral Needle Ablation of Prostate | Transurethral Microwave Thermotherapy | Operative Surgical Procedures Radical Prostate carcinoma
Item
no prior chemotherapy, pelvic radiation, transurethral prostatectomy (turp), cryosurgery, tuna, transurethral microwave thermotherapy (tumt) or radical surgery for carcinoma of the prostate is allowed.
boolean
C0392920 (UMLS CUI [1])
C1536155 (UMLS CUI [2])
C0040771 (UMLS CUI [3])
C0010408 (UMLS CUI [4])
C1138404 (UMLS CUI [5])
C1136095 (UMLS CUI [6])
C0543467 (UMLS CUI [7,1])
C0439807 (UMLS CUI [7,2])
C0600139 (UMLS CUI [7,3])
Hormone Therapy
Item
no previous hormonal therapy beginning < 2 months or > 6 months prior to registration is allowed.
boolean
C0279025 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in Situ | Squamous cell carcinoma of skin | Disease Free of
Item
no previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0007099 (UMLS CUI [3])
C0553723 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
Hip Prosthesis | Illness Major | Mental disorders Major
Item
no hip prosthesis or major medical or psychiatric illnesses are allowed. prior to study entry.
boolean
C0019560 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0004936 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
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