ID

40457

Beschreibung

Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation; ODM derived from: https://clinicaltrials.gov/show/NCT01856543

Link

https://clinicaltrials.gov/show/NCT01856543

Stichworte

Versionen (2)
  1. 23.04.20 23.04.20 -
  2. 23.04.20 23.04.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

23. April 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Invasive Breast Cancer NCT01856543

Englisch

Eligibility Invasive Breast Cancer NCT01856543

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
stage 1-4 invasive breast cancer that is histologically confirmed at mskcc
Beschreibung

Invasive carcinoma of breast TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive pmrt
Beschreibung

Status post Mastectomy | Exploration Axillary | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes | Therapeutic radiology procedure Post Mastectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0024881
UMLS CUI [2,1]
C1280903
UMLS CUI [2,2]
C0004454
UMLS CUI [3]
C0796693
UMLS CUI [4]
C0193867
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0024881
ecog performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
male
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
patients with clinical evidence of gross disease
Beschreibung

Disease Gross

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439806
patients who are pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior radiation therapy to the ipsilateral chest wall or thorax
Beschreibung

Prior radiation therapy Chest wall Ipsilateral | Prior radiation therapy Chest

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205076
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0817096
patients requiring a chest wall boost
Beschreibung

Patient need for Boost radiation Chest wall

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C2919491
UMLS CUI [1,3]
C0205076
concurrent chemotherapy (biologic agents are allowed)
Beschreibung

Chemotherapy Concurrent | Biological agents allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205420
UMLS CUI [2,1]
C0005515
UMLS CUI [2,2]
C0683607
psychiatric illness that would prevent the patient from giving informed consent
Beschreibung

Mental disorders Preventing Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
inability or unwillingness to comply with skin care instructions and follow-up
Beschreibung

Compliance behavior Unable Skin Care | Compliance behavior Unwilling Skin Care | Compliance behavior Unable Follow-up | Compliance behavior Unwilling Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0150773
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0558080
UMLS CUI [2,3]
C0150773
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C1299582
UMLS CUI [3,3]
C3274571
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0558080
UMLS CUI [4,3]
C3274571
allergy to either eucerin or mf
Beschreibung

Hypersensitivity Eucerin | Hypersensitivity Mometasone furoate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0164056
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0066700
residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of rt
Beschreibung

Skin toxicity Residual CTCAE Grades | Cellulitis | Wound, non-healed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1167791
UMLS CUI [1,2]
C1609982
UMLS CUI [1,3]
C1516728
UMLS CUI [2]
C0007642
UMLS CUI [3]
C0750433
medical condition such as uncontrolled infection (including hiv), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)
Beschreibung

Other medical condition | Communicable Disease Uncontrolled | HIV Infection Uncontrolled | Diabetic - poor control | Connective Tissue Diseases | Lupus Erythematosus | Systemic Sclerosis | Collagen-vascular disease

Datentyp

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0019693
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0421258
UMLS CUI [5]
C0009782
UMLS CUI [6]
C0409974
UMLS CUI [7]
C0036421
UMLS CUI [8]
C0262428
treatment with palliative or pre-operative radiation
Beschreibung

Palliative Radiation Therapy | Therapeutic radiology procedure Preoperative

Datentyp

boolean

Alias
UMLS CUI [1]
C3898008
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0445204
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Ähnliche Modelle

Eligibility Invasive Breast Cancer NCT01856543

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast TNM Breast tumor staging
Item
stage 1-4 invasive breast cancer that is histologically confirmed at mskcc
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Status post Mastectomy | Exploration Axillary | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes | Therapeutic radiology procedure Post Mastectomy
Item
status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive pmrt
boolean
C0231290 (UMLS CUI [1,1])
C0024881 (UMLS CUI [1,2])
C1280903 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
C0796693 (UMLS CUI [3])
C0193867 (UMLS CUI [4])
C1522449 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0024881 (UMLS CUI [5,3])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender
Item
male
boolean
C0079399 (UMLS CUI [1])
Disease Gross
Item
patients with clinical evidence of gross disease
boolean
C0012634 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
patients who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior radiation therapy Chest wall Ipsilateral | Prior radiation therapy Chest
Item
prior radiation therapy to the ipsilateral chest wall or thorax
boolean
C0279134 (UMLS CUI [1,1])
C0205076 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0817096 (UMLS CUI [2,2])
Patient need for Boost radiation Chest wall
Item
patients requiring a chest wall boost
boolean
C0686904 (UMLS CUI [1,1])
C2919491 (UMLS CUI [1,2])
C0205076 (UMLS CUI [1,3])
Chemotherapy Concurrent | Biological agents allowed
Item
concurrent chemotherapy (biologic agents are allowed)
boolean
C0392920 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0005515 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Mental disorders Preventing Informed Consent
Item
psychiatric illness that would prevent the patient from giving informed consent
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Compliance behavior Unable Skin Care | Compliance behavior Unwilling Skin Care | Compliance behavior Unable Follow-up | Compliance behavior Unwilling Follow-up
Item
inability or unwillingness to comply with skin care instructions and follow-up
boolean
C1321605 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0150773 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0150773 (UMLS CUI [2,3])
C1321605 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C1321605 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
Hypersensitivity Eucerin | Hypersensitivity Mometasone furoate
Item
allergy to either eucerin or mf
boolean
C0020517 (UMLS CUI [1,1])
C0164056 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0066700 (UMLS CUI [2,2])
Skin toxicity Residual CTCAE Grades | Cellulitis | Wound, non-healed
Item
residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of rt
boolean
C1167791 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0007642 (UMLS CUI [2])
C0750433 (UMLS CUI [3])
Other medical condition | Communicable Disease Uncontrolled | HIV Infection Uncontrolled | Diabetic - poor control | Connective Tissue Diseases | Lupus Erythematosus | Systemic Sclerosis | Collagen-vascular disease
Item
medical condition such as uncontrolled infection (including hiv), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)
boolean
C3843040 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0019693 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0421258 (UMLS CUI [4])
C0009782 (UMLS CUI [5])
C0409974 (UMLS CUI [6])
C0036421 (UMLS CUI [7])
C0262428 (UMLS CUI [8])
Palliative Radiation Therapy | Therapeutic radiology procedure Preoperative
Item
treatment with palliative or pre-operative radiation
boolean
C3898008 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
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