ID

38001

Beskrivning

Non-Invasive Imaging for Cording in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01427166

Länk

https://clinicaltrials.gov/show/NCT01427166

Nyckelord

Versioner (1)
  1. 2019-09-06 2019-09-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01427166

Engelsk

Eligibility Breast Cancer NCT01427166

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must be enrolled in partners protocol # 2008p000540 "prospective analysis of symptoms, functionality and quality of life questionnaires to evaluate lymphedema in patients following treatment for breast cancer"
Beskrivning

Enrollment Study Protocol Specified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0205369
confirmed case of cording by a medical provider (physician, nurse practitioner, physician assistant)
Beskrivning

Cording

Datatyp

boolean

Alias
UMLS CUI [1]
C3698497
participants must be at least 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of greater than 1 year.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
ability to understand and the willingness to sign a written informed consent document.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
willingness to comply with required follow up perometer measurements and clinical visits.
Beskrivning

Compliance behavior Follow-up | Other Coding | Compliance behavior Clinic Visits

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0008952
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who are not enrolled or have been removed from partners protocol #
Beskrivning

Lacking Enrollment Study Protocol Specified | Patient withdrawn from Study Protocol Specified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0205369
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0205369
2008p000540 will be excluded from this trial.
Beskrivning

ID.8

Datatyp

boolean

participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Beskrivning

Metastatic malignant neoplasm to brain | Rationale Prognosis bad | Rationale Development Neurologic Dysfunction Progressive | Rationale Interference Evaluation

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C2699007
UMLS CUI [2,2]
C0278252
UMLS CUI [3,1]
C2699007
UMLS CUI [3,2]
C0243107
UMLS CUI [3,3]
C0751377
UMLS CUI [3,4]
C0205329
UMLS CUI [4,1]
C2699007
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
history of prior surgery or radiation to the head, neck, upper limb, or trunk.
Beskrivning

Operative procedure on head | Irradiation of head | Operation on neck | Irradiation of neck | Operative procedure on upper extremity | UPPER EXTREMITY RADIATION | Operation on trunk | Therapeutic radiology procedure Trunk

Datatyp

boolean

Alias
UMLS CUI [1]
C0195772
UMLS CUI [2]
C2064931
UMLS CUI [3]
C0185773
UMLS CUI [4]
C0746818
UMLS CUI [5]
C0186318
UMLS CUI [6]
C0749835
UMLS CUI [7]
C0185774
UMLS CUI [8,1]
C1522449
UMLS CUI [8,2]
C0460005
patients with a history of a different malignancy are ineligible except for the following circumstances. individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Beskrivning

Malignant Neoplasms | Exception Disease Free Duration | Exception Low Risk Recurrent tumor | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3538919
UMLS CUI [3,3]
C0521158
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0553723
UMLS CUI [6,3]
C1522326
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Similar models

Eligibility Breast Cancer NCT01427166

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Enrollment Study Protocol Specified
Item
participants must be enrolled in partners protocol # 2008p000540 "prospective analysis of symptoms, functionality and quality of life questionnaires to evaluate lymphedema in patients following treatment for breast cancer"
boolean
C1516879 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Cording
Item
confirmed case of cording by a medical provider (physician, nurse practitioner, physician assistant)
boolean
C3698497 (UMLS CUI [1])
Age
Item
participants must be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 1 year.
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Follow-up | Other Coding | Compliance behavior Clinic Visits
Item
willingness to comply with required follow up perometer measurements and clinical visits.
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0008952 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Lacking Enrollment Study Protocol Specified | Patient withdrawn from Study Protocol Specified
Item
participants who are not enrolled or have been removed from partners protocol #
boolean
C0332268 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C0422727 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
ID.8
Item
2008p000540 will be excluded from this trial.
boolean
Metastatic malignant neoplasm to brain | Rationale Prognosis bad | Rationale Development Neurologic Dysfunction Progressive | Rationale Interference Evaluation
Item
participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
boolean
C0220650 (UMLS CUI [1])
C2699007 (UMLS CUI [2,1])
C0278252 (UMLS CUI [2,2])
C2699007 (UMLS CUI [3,1])
C0243107 (UMLS CUI [3,2])
C0751377 (UMLS CUI [3,3])
C0205329 (UMLS CUI [3,4])
C2699007 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
Operative procedure on head | Irradiation of head | Operation on neck | Irradiation of neck | Operative procedure on upper extremity | UPPER EXTREMITY RADIATION | Operation on trunk | Therapeutic radiology procedure Trunk
Item
history of prior surgery or radiation to the head, neck, upper limb, or trunk.
boolean
C0195772 (UMLS CUI [1])
C2064931 (UMLS CUI [2])
C0185773 (UMLS CUI [3])
C0746818 (UMLS CUI [4])
C0186318 (UMLS CUI [5])
C0749835 (UMLS CUI [6])
C0185774 (UMLS CUI [7])
C1522449 (UMLS CUI [8,1])
C0460005 (UMLS CUI [8,2])
Malignant Neoplasms | Exception Disease Free Duration | Exception Low Risk Recurrent tumor | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
patients with a history of a different malignancy are ineligible except for the following circumstances. individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0521158 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0553723 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
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