ID

38240

Beschrijving

HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02165605

Link

https://clinicaltrials.gov/show/NCT02165605

Trefwoorden

Versies (1)
  1. 01-10-19 01-10-19 -
Houder van rechten

See clinicaltrials.gov

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1 oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02165605

Engels

Eligibility Breast Cancer NCT02165605

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female, age 18 or older
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
diagnosis of breast cancer
Beschrijving

Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
intact breast (not surgically absent)
Beschrijving

Breast Intact

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0205266
planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 gy in 28 fractions with a planned photon or electron boost of 10gy in 5 fractions (for a total of 33 fractions)
Beschrijving

Teleradiotherapy Fractionated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0419095
UMLS CUI [1,2]
C1979893
ability to understand and comply with the requirements of this study
Beschrijving

Comprehension Study Protocol | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
ability to give informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
for sexually active females, patient agrees to use acceptable method of birth control
Beschrijving

Gender Sexually active Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or lactating
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of concomitant skin care preparations at any of the treated or control portal areas to be observed
Beschrijving

Skin Care Preparations Portal triad area

Datatype

boolean

Alias
UMLS CUI [1,1]
C0150773
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0734842
any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
Beschrijving

Communicable Disease Therapeutic radiology procedure Portal triad area | Non-healed wound Therapeutic radiology procedure Portal triad area | Generalized dermatitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0734842
UMLS CUI [2,1]
C0750433
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0734842
UMLS CUI [3]
C0262995
severe renal failure creatinine > 3.0 within 6 months of study registration
Beschrijving

Kidney Failure Severe | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
Beschrijving

Patient allergic history | Anaphylaxis | Severe allergy Investigational New Drugs | Severe allergy Placebo products

Datatype

boolean

Alias
UMLS CUI [1]
C3841443
UMLS CUI [2]
C0002792
UMLS CUI [3,1]
C2945656
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C2945656
UMLS CUI [4,2]
C1696465
UMLS CUI [4,3]
C1514468
planned relocation which would make follow-up visits impossible during the course of the study
Beschrijving

Relocation of home Planned | Follow-up visit Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C1272705
collagen vascular disease such as lupus, or scleroderma
Beschrijving

Collagen-vascular disease | Lupus Erythematosus | Scleroderma

Datatype

boolean

Alias
UMLS CUI [1]
C0262428
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0011644
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Similar models

Eligibility Breast Cancer NCT02165605

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female, age 18 or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Breast Intact
Item
intact breast (not surgically absent)
boolean
C0006141 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
Teleradiotherapy Fractionated
Item
planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 gy in 28 fractions with a planned photon or electron boost of 10gy in 5 fractions (for a total of 33 fractions)
boolean
C0419095 (UMLS CUI [1,1])
C1979893 (UMLS CUI [1,2])
Comprehension Study Protocol | Protocol Compliance
Item
ability to understand and comply with the requirements of this study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Informed Consent
Item
ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
Gender Sexually active Contraceptive methods
Item
for sexually active females, patient agrees to use acceptable method of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Skin Care Preparations Portal triad area
Item
use of concomitant skin care preparations at any of the treated or control portal areas to be observed
boolean
C0150773 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0734842 (UMLS CUI [1,3])
Communicable Disease Therapeutic radiology procedure Portal triad area | Non-healed wound Therapeutic radiology procedure Portal triad area | Generalized dermatitis
Item
any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
boolean
C0009450 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0734842 (UMLS CUI [1,3])
C0750433 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0734842 (UMLS CUI [2,3])
C0262995 (UMLS CUI [3])
Kidney Failure Severe | Creatinine measurement, serum
Item
severe renal failure creatinine > 3.0 within 6 months of study registration
boolean
C0035078 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Patient allergic history | Anaphylaxis | Severe allergy Investigational New Drugs | Severe allergy Placebo products
Item
allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
boolean
C3841443 (UMLS CUI [1])
C0002792 (UMLS CUI [2])
C2945656 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C2945656 (UMLS CUI [4,1])
C1696465 (UMLS CUI [4,2])
C1514468 (UMLS CUI [4,3])
Relocation of home Planned | Follow-up visit Unsuccessful
Item
planned relocation which would make follow-up visits impossible during the course of the study
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0589121 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Collagen-vascular disease | Lupus Erythematosus | Scleroderma
Item
collagen vascular disease such as lupus, or scleroderma
boolean
C0262428 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0011644 (UMLS CUI [3])
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