ID

38110

Description

Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation; ODM derived from: https://clinicaltrials.gov/show/NCT01762020

Link

https://clinicaltrials.gov/show/NCT01762020

Keywords

Versions (1)
  1. 9/18/19 9/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01762020

English

Eligibility Breast Cancer NCT01762020

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients between 18 and 80 years of age at the time of enrollment
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histopathologically or cytologically confirmed diagnosis of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
completed lumpectomy and sentinel lymph node biopsy or axillary lymph node dissection
Description

Segmental Mastectomy Completed | Sentinel Lymph Node Biopsy Completed | Excision of axillary lymph nodes Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0024885
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0796693
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0193867
UMLS CUI [3,2]
C0205197
signed and dated ethics-approved informed consent form prior to any study procedures
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ability to comply with the requirements of the study
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
scheduled adjuvant radiation therapy treatment
Description

Adjuvant Radiation Therapy Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C1706721
UMLS CUI [1,2]
C0205539
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical or radiological evidence of local recurrence or metastatic disease
Description

Recurrent disease Locally | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C0027627
previous history of radiation therapy to ipsilateral axilla and/or breast area
Description

Prior radiation therapy Axilla Ipsilateral | Prior radiation therapy Breast Ipsilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0004454
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C0441989
planned boost of radiation dementia, psychoses, or other significant impairment of mental status that would prohibit the understanding and giving of informed consent or the participation in self-care or toxicity reporting
Description

Boost radiation therapy Planned | Dementia | Psychotic Disorders | Mental state Impairment Preventing Informed Consent | Mental state Impairment Preventing Self-care | Mental state Preventing Toxicity Reporting

Data type

boolean

Alias
UMLS CUI [1,1]
C2919491
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0033975
UMLS CUI [4,1]
C0278060
UMLS CUI [4,2]
C0221099
UMLS CUI [4,3]
C1292733
UMLS CUI [4,4]
C0021430
UMLS CUI [5,1]
C0278060
UMLS CUI [5,2]
C0221099
UMLS CUI [5,3]
C1292733
UMLS CUI [5,4]
C3872897
UMLS CUI [6,1]
C0278060
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C0600688
UMLS CUI [6,4]
C0700287
any significant history or concurrent disease which, in the judgment of the investigator would make the patient inappropriate for entry to this study
Description

Medical History Study Subject Participation Status Inappropriate | Comorbidity Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
history of contraindications of radiation such as scleroderma
Description

Medical contraindication Therapeutic radiology procedure | Scleroderma

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1522449
UMLS CUI [2]
C0011644
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Similar models

Eligibility Breast Cancer NCT01762020

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients between 18 and 80 years of age at the time of enrollment
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
histopathologically or cytologically confirmed diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Segmental Mastectomy Completed | Sentinel Lymph Node Biopsy Completed | Excision of axillary lymph nodes Completed
Item
completed lumpectomy and sentinel lymph node biopsy or axillary lymph node dissection
boolean
C0024885 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0796693 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0193867 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Informed Consent
Item
signed and dated ethics-approved informed consent form prior to any study procedures
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
ability to comply with the requirements of the study
boolean
C0525058 (UMLS CUI [1])
Adjuvant Radiation Therapy Scheduled
Item
scheduled adjuvant radiation therapy treatment
boolean
C1706721 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Recurrent disease Locally | Neoplasm Metastasis
Item
clinical or radiological evidence of local recurrence or metastatic disease
boolean
C0277556 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
Prior radiation therapy Axilla Ipsilateral | Prior radiation therapy Breast Ipsilateral
Item
previous history of radiation therapy to ipsilateral axilla and/or breast area
boolean
C0279134 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
Boost radiation therapy Planned | Dementia | Psychotic Disorders | Mental state Impairment Preventing Informed Consent | Mental state Impairment Preventing Self-care | Mental state Preventing Toxicity Reporting
Item
planned boost of radiation dementia, psychoses, or other significant impairment of mental status that would prohibit the understanding and giving of informed consent or the participation in self-care or toxicity reporting
boolean
C2919491 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0497327 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0278060 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C1292733 (UMLS CUI [4,3])
C0021430 (UMLS CUI [4,4])
C0278060 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
C1292733 (UMLS CUI [5,3])
C3872897 (UMLS CUI [5,4])
C0278060 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C0600688 (UMLS CUI [6,3])
C0700287 (UMLS CUI [6,4])
Medical History Study Subject Participation Status Inappropriate | Comorbidity Study Subject Participation Status Inappropriate
Item
any significant history or concurrent disease which, in the judgment of the investigator would make the patient inappropriate for entry to this study
boolean
C0262926 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Medical contraindication Therapeutic radiology procedure | Scleroderma
Item
history of contraindications of radiation such as scleroderma
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0011644 (UMLS CUI [2])
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