ID

40457

Beschrijving

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

Trefwoorden

Versies (2)
  1. 23-04-20 23-04-20 -
  2. 23-04-20 23-04-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 april 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Invasive Breast Cancer NCT01856543

Engels

Eligibility Invasive Breast Cancer NCT01856543

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years
Beschrijving

Age

Datatype

boolean

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

Invasive carcinoma of breast TNM Breast tumor staging

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
male
Beschrijving

Gender

Datatype

boolean

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

Disease Gross

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Prior radiation therapy Chest wall Ipsilateral | Prior radiation therapy Chest

Datatype

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
Beschrijving

Patient need for Boost radiation Chest wall

Datatype

boolean

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

Chemotherapy Concurrent | Biological agents allowed

Datatype

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
Beschrijving

Mental disorders Preventing Informed Consent

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Hypersensitivity Eucerin | Hypersensitivity Mometasone furoate

Datatype

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
Beschrijving

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

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Palliative Radiation Therapy | Therapeutic radiology procedure Preoperative

Datatype

boolean

Alias
UMLS CUI [1]
C3898008
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0445204
Terug naar het begin van de pagina

Similar models

Eligibility Invasive Breast Cancer NCT01856543

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial