ID

40929

Beskrivning

Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01488968

Länk

https://clinicaltrials.gov/show/NCT01488968

Nyckelord

Versioner (1)
  1. 2020-06-06 2020-06-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 juni 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility High-risk Prostate Cancer NCT01488968

Engelsk

Eligibility High-risk Prostate Cancer NCT01488968

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 18 years of age or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patient has histologically proven adenocarcinoma of prostate gland by needle core samples or turp with assigned gleason score. prostate biopsy performed within 180 days of enrollment (date of consent).
Beskrivning

Adenocarcinoma of prostate | Core needle biopsy of prostate | Transurethral Resection of Prostate | Gleason score | Biopsy of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C0194806
UMLS CUI [3]
C0040771
UMLS CUI [4]
C3203027
UMLS CUI [5]
C0194804
patient has high-risk prostate cancer (stage t3 or t4) and/or psa greater than or equal to 20 ng/ml and/or gleason score 8 to 10
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0201544
UMLS CUI [3]
C3203027
no clinical or radiological evidence of nodal or distant metastasis(es).
Beskrivning

Secondary malignant neoplasm of lymph node Absent | Distant metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686619
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
in the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. patients are accessible for treatment and follow up.
Beskrivning

Patient Fit External beam radiotherapy to prostate | Patients Available Therapy | Patients Available Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0424576
UMLS CUI [1,3]
C2367589
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0470187
UMLS CUI [3,3]
C3274571
patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
Beskrivning

Inflammatory Bowel Disease Absent | Stricture of anus Absent | Colon and Rectal Surgery Absent | Absence Endoscopy Relationship Anorectal Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021390
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0262374
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C2608114
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0014245
UMLS CUI [4,3]
C0439849
UMLS CUI [4,4]
C0687707
no history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.
Beskrivning

Prostatectomy Absent | Transurethral Resection of Prostate Repeated Absent | Radiotherapy to pelvis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0040771
UMLS CUI [2,2]
C0205341
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1536155
UMLS CUI [3,2]
C0332197
no history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.
Beskrivning

Androgen suppression Absent | Androgen suppression Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515985
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1515985
UMLS CUI [2,2]
C0600109
no previous malignancy within last five years except bcc or scc skin or highly curable malignancy where a prognosis for cure is > 80%.
Beskrivning

Malignant Neoplasms Absent | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Malignant Neoplasm Cure Very likely

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C1880198
UMLS CUI [4,4]
C3840799
patient signed informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility High-risk Prostate Cancer NCT01488968

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate | Core needle biopsy of prostate | Transurethral Resection of Prostate | Gleason score | Biopsy of prostate
Item
patient has histologically proven adenocarcinoma of prostate gland by needle core samples or turp with assigned gleason score. prostate biopsy performed within 180 days of enrollment (date of consent).
boolean
C0007112 (UMLS CUI [1])
C0194806 (UMLS CUI [2])
C0040771 (UMLS CUI [3])
C3203027 (UMLS CUI [4])
C0194804 (UMLS CUI [5])
High risk Prostate carcinoma TNM clinical staging | Prostate specific antigen measurement | Gleason score
Item
patient has high-risk prostate cancer (stage t3 or t4) and/or psa greater than or equal to 20 ng/ml and/or gleason score 8 to 10
boolean
C4319571 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0201544 (UMLS CUI [2])
C3203027 (UMLS CUI [3])
Secondary malignant neoplasm of lymph node Absent | Distant metastasis Absent
Item
no clinical or radiological evidence of nodal or distant metastasis(es).
boolean
C0686619 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Patient Fit External beam radiotherapy to prostate | Patients Available Therapy | Patients Available Follow-up
Item
in the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. patients are accessible for treatment and follow up.
boolean
C0030705 (UMLS CUI [1,1])
C0424576 (UMLS CUI [1,2])
C2367589 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
Inflammatory Bowel Disease Absent | Stricture of anus Absent | Colon and Rectal Surgery Absent | Absence Endoscopy Relationship Anorectal Disease
Item
patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
boolean
C0021390 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0262374 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2608114 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0014245 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C0687707 (UMLS CUI [4,4])
Prostatectomy Absent | Transurethral Resection of Prostate Repeated Absent | Radiotherapy to pelvis Absent
Item
no history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.
boolean
C0033573 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0040771 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1536155 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Androgen suppression Absent | Androgen suppression Willing
Item
no history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.
boolean
C1515985 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1515985 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Malignant Neoplasms Absent | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Malignant Neoplasm Cure Very likely
Item
no previous malignancy within last five years except bcc or scc skin or highly curable malignancy where a prognosis for cure is > 80%.
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
C3840799 (UMLS CUI [4,4])
Informed Consent
Item
patient signed informed consent.
boolean
C0021430 (UMLS CUI [1])
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