ID

31615

Beschrijving

Hybrid PET/MR in the Therapy of Cervical Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01759355 Sponsor: UNC Lineberger Comprehensive Cancer Center Information provided by (Responsible Party): UNC Lineberger Comprehensive Cancer Center Principal Investigator: Jorge Oldan, MD University of North Carolina, Chapel Hill

Link

https://clinicaltrials.gov/show/NCT01759355

Trefwoorden

Versies (1)
  1. 12-09-18 12-09-18 -
Houder van rechten

UNC Lineberger Comprehensive Cancer Center

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12 september 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Cervix Carcinoma NCT01759355

Engels

Eligibility Cervix Carcinoma NCT01759355

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix
Beschrijving

Histologically confirmed, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix

Datatype

boolean

Alias
UMLS CUI [1,1]
C0346202
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0449575
UMLS CUI [2,2]
C0279671
UMLS CUI [2,3]
C0332155
UMLS CUI [3,1]
C0279672
UMLS CUI [3,2]
C0332155
clinically visible lesion at least figo stage ib or ajcc 7th edition t1b
Beschrijving

clinically visible lesion at least figo stage ib or ajcc t1b

Datatype

boolean

Alias
UMLS CUI [1,1]
C0439806
UMLS CUI [1,2]
C0221198
UMLS CUI [2]
C0474956
UMLS CUI [3]
C0441915
scheduled to undergo standard of care pet/ct for baseline assessment of disease
Beschrijving

Scheduled for pet/ct for baseline assessment of disease

Datatype

boolean

Alias
UMLS CUI [1]
C1699633
anticipated to be eligible for curative intent therapy (surgery or chemoradiation therapy) as determined by the patient's primary oncologist
Beschrijving

Eligible for curative intent therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1276305
if female of child-bearing potential, negative serum or urine pregnancy test ≤ 7 dats prior to first pet/mri
Beschrijving

Negative pregnancy test prior to first pet/mri

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
informed consent reviewed and signed
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of sever reaction to contrast-enhanced ct scan
Beschrijving

Contrast agent allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0009924
inability to tolerate mri (e.g., inability to lie flat > 1 hour)
Beschrijving

Inability to tolerate mri

Datatype

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0917711
presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
Beschrijving

Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes

Datatype

boolean

Alias
UMLS CUI [1]
C0848753
UMLS CUI [2,1]
C0524466
UMLS CUI [2,2]
C0179977
UMLS CUI [3]
C0401423
UMLS CUI [4]
C0009199
UMLS CUI [5,1]
C0025552
UMLS CUI [5,2]
C1706276
UMLS CUI [5,3]
C0015392
poorly controlled diabetes mellitus
Beschrijving

Poorly controlled diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0554876
creatinine > 1.4 mg/dl or gfr < 30 ml/min
Beschrijving

Creatinine > 1.4 mg/dl or gfr < 30 ml/min

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0017654
body mass index (bmi) > 35
Beschrijving

body mass index (bmi) > 35

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
active vaginal bleeding requiring packing and emergent radiation therapy
Beschrijving

active vaginal bleeding requiring packing and emergent radiation therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C2979982
UMLS CUI [1,2]
C0750573
UMLS CUI [1,3]
C0184967
UMLS CUI [1,4]
C1522449
pregnant or lactating female
Beschrijving

Pregnant or lactating female

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
history of a prior malignancy within past 5 years, unless disease free for ≥ 3 years
Beschrijving

History of prior malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C2735087
substance abuse, medical, psychological, or social conditions that may interfere with study participation
Beschrijving

Ineligibility due to substance abuse or other medical, psychological or social conditions

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C1301624
UMLS CUI [3,1]
C0205486
UMLS CUI [3,2]
C0522473
UMLS CUI [4,1]
C0728831
UMLS CUI [4,2]
C0522473
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Similar models

Eligibility Cervix Carcinoma NCT01759355

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Histologically confirmed, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix
Item
biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix
boolean
C0346202 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0449575 (UMLS CUI [2,1])
C0279671 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0279672 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
clinically visible lesion at least figo stage ib or ajcc t1b
Item
clinically visible lesion at least figo stage ib or ajcc 7th edition t1b
boolean
C0439806 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0474956 (UMLS CUI [2])
C0441915 (UMLS CUI [3])
Scheduled for pet/ct for baseline assessment of disease
Item
scheduled to undergo standard of care pet/ct for baseline assessment of disease
boolean
C1699633 (UMLS CUI [1])
Eligible for curative intent therapy
Item
anticipated to be eligible for curative intent therapy (surgery or chemoradiation therapy) as determined by the patient's primary oncologist
boolean
C1548635 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
Negative pregnancy test prior to first pet/mri
Item
if female of child-bearing potential, negative serum or urine pregnancy test ≤ 7 dats prior to first pet/mri
boolean
C0427780 (UMLS CUI [1])
Informed consent
Item
informed consent reviewed and signed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Contrast agent allergy
Item
history of sever reaction to contrast-enhanced ct scan
boolean
C0020517 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
Inability to tolerate mri
Item
inability to tolerate mri (e.g., inability to lie flat > 1 hour)
boolean
C1299582 (UMLS CUI [1,1])
C0917711 (UMLS CUI [1,2])
Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
Item
presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
boolean
C0848753 (UMLS CUI [1])
C0524466 (UMLS CUI [2,1])
C0179977 (UMLS CUI [2,2])
C0401423 (UMLS CUI [3])
C0009199 (UMLS CUI [4])
C0025552 (UMLS CUI [5,1])
C1706276 (UMLS CUI [5,2])
C0015392 (UMLS CUI [5,3])
Poorly controlled diabetes mellitus
Item
poorly controlled diabetes mellitus
boolean
C0554876 (UMLS CUI [1])
Creatinine > 1.4 mg/dl or gfr < 30 ml/min
Item
creatinine > 1.4 mg/dl or gfr < 30 ml/min
boolean
C0373595 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
body mass index (bmi) > 35
Item
body mass index (bmi) > 35
boolean
C1305855 (UMLS CUI [1])
active vaginal bleeding requiring packing and emergent radiation therapy
Item
active vaginal bleeding requiring packing and emergent radiation therapy
boolean
C2979982 (UMLS CUI [1,1])
C0750573 (UMLS CUI [1,2])
C0184967 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
Pregnant or lactating female
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
History of prior malignancy
Item
history of a prior malignancy within past 5 years, unless disease free for ≥ 3 years
boolean
C2735087 (UMLS CUI [1])
Ineligibility due to substance abuse or other medical, psychological or social conditions
Item
substance abuse, medical, psychological, or social conditions that may interfere with study participation
boolean
C0038586 (UMLS CUI [1])
C1301624 (UMLS CUI [2])
C0205486 (UMLS CUI [3,1])
C0522473 (UMLS CUI [3,2])
C0728831 (UMLS CUI [4,1])
C0522473 (UMLS CUI [4,2])
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