ID

36566

Description

Pilot Study of Gamma H2AX DNA Repair Foci Kinetics in Peripheral Blood Lymphocytes During Prostate Cancer Radiotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01899391

Link

https://clinicaltrials.gov/show/NCT01899391

Keywords

Versions (2)
  1. 1/17/19 1/17/19 -
  2. 5/22/19 5/22/19 -
Copyright Holder

University Health Network, Toronto

Uploaded on

May 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Gamma H2AX DNA Repair During Prostate Cancer Radiotherapy NCT01899391

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Intermediate-risk prostate cancer patients (T1/T2N0M0 with either GS < 7 and PSA between 10-20 ng/ml or GS 7 and PSA less than 20 ng/ml).
Description

Prostate cancer risk assessment (from TNM, GS and PSA)

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0086930
UMLS CUI [2]
C1515169
UMLS CUI [3]
C3203027
UMLS CUI [4]
C0201544
planned for radical RT to the prostate with IMRT planning (79Gy/39 fractions or 60 Gy/20 fractions)
Description

planned for radical RT to the prostate with IMRT planning

Data type

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0439807
UMLS CUI [1,3]
C0033572
UMLS CUI [1,4]
C1512814
UMLS CUI [2]
C2169193
UMLS CUI [3]
C0454266
no contraindications to diagnostic CT scanning
Description

no contraindications to diagnostic CT scanning

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0040405
prostate volumes will be less than 80 cc to control the planning dose volume histogram (DVH) as much as possible in terms of rectal and bladder volumes
Description

prostate volume

Data type

boolean

Alias
UMLS CUI [1]
C1441416
UMLS CUI [2,1]
C3827011
UMLS CUI [2,2]
C0034896
UMLS CUI [3,1]
C3827011
UMLS CUI [3,2]
C0005682
no known DNA repair disorders (e.g. family history of AT, BRCA1/2 or Li Fraumeni syndrome) or contraindications to radical pelvic RT
Description

no known DNA repair disorders (e.g. AT, BRCA1/2, Li Fraumeni) or contraindications to radical pelvic RT

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0012899
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0241889
UMLS CUI [2,3]
C0004135
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C4543583
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0241889
UMLS CUI [4,3]
C0085390
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0522473
UMLS CUI [5,3]
C0439807
UMLS CUI [5,4]
C1536155
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to provide informed consent
Description

inability to provide informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
patient having contraindications to diagnostic CT scan
Description

contraindications to diagnostic CT scan

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0040405
patients who have unobtainable data regarding previous therapy and their clinical outcome
Description

patients with unobtainable data regarding previous therapy and their clinical outcome

Data type

boolean

Alias
UMLS CUI [1,1]
C2046401
UMLS CUI [1,2]
C2114510
UMLS CUI [2,1]
C2046401
UMLS CUI [2,2]
C2114510
UMLS CUI [2,3]
C1547647
Patients should not have any diagnostic X-rays or CAT scans 2 weeks prior to their enrollment into the study
Description

Recent diagnostic X-rays or CAT scans

Data type

boolean

Alias
UMLS CUI [1,1]
C0043299
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0040405
UMLS CUI [2,2]
C0332185
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate cancer risk assessment (from TNM, GS and PSA)
Item
Intermediate-risk prostate cancer patients (T1/T2N0M0 with either GS < 7 and PSA between 10-20 ng/ml or GS 7 and PSA less than 20 ng/ml).
boolean
C0600139 (UMLS CUI [1,1])
C0086930 (UMLS CUI [1,2])
C1515169 (UMLS CUI [2])
C3203027 (UMLS CUI [3])
C0201544 (UMLS CUI [4])
planned for radical RT to the prostate with IMRT planning
Item
planned for radical RT to the prostate with IMRT planning (79Gy/39 fractions or 60 Gy/20 fractions)
boolean
C1301732 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
C0033572 (UMLS CUI [1,3])
C1512814 (UMLS CUI [1,4])
C2169193 (UMLS CUI [2])
C0454266 (UMLS CUI [3])
no contraindications to diagnostic CT scanning
Item
no contraindications to diagnostic CT scanning
boolean
C0332197 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
prostate volume
Item
prostate volumes will be less than 80 cc to control the planning dose volume histogram (DVH) as much as possible in terms of rectal and bladder volumes
boolean
C1441416 (UMLS CUI [1])
C3827011 (UMLS CUI [2,1])
C0034896 (UMLS CUI [2,2])
C3827011 (UMLS CUI [3,1])
C0005682 (UMLS CUI [3,2])
no known DNA repair disorders (e.g. AT, BRCA1/2, Li Fraumeni) or contraindications to radical pelvic RT
Item
no known DNA repair disorders (e.g. family history of AT, BRCA1/2 or Li Fraumeni syndrome) or contraindications to radical pelvic RT
boolean
C0332197 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012899 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0004135 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C4543583 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0241889 (UMLS CUI [4,2])
C0085390 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0522473 (UMLS CUI [5,2])
C0439807 (UMLS CUI [5,3])
C1536155 (UMLS CUI [5,4])
Item Group
C0680251 (UMLS CUI)
inability to provide informed consent
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
contraindications to diagnostic CT scan
Item
patient having contraindications to diagnostic CT scan
boolean
C1301624 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
patients with unobtainable data regarding previous therapy and their clinical outcome
Item
patients who have unobtainable data regarding previous therapy and their clinical outcome
boolean
C2046401 (UMLS CUI [1,1])
C2114510 (UMLS CUI [1,2])
C2046401 (UMLS CUI [2,1])
C2114510 (UMLS CUI [2,2])
C1547647 (UMLS CUI [2,3])
Recent diagnostic X-rays or CAT scans
Item
Patients should not have any diagnostic X-rays or CAT scans 2 weeks prior to their enrollment into the study
boolean
C0043299 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
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