ID

34973

Description

Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT02061527

Link

https://clinicaltrials.gov/show/NCT02061527

Keywords

Versions (1)
  1. 2/6/19 2/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02061527

English

Eligibility Breast Cancer NCT02061527

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with invasive or pre-invasive (in situ) breast cancer, planned for immediate breast reconstruction post-skin sparing or nipple sparing mastectomy (unilateral or bilateral)
Description

Invasive carcinoma of breast | Carcinoma in Situ Breast | Mammaplasty Immediate Planned | Status post Skin sparing mastectomy Unilateral | Status post Subcutaneous Mastectomy Unilateral | Status post Skin sparing mastectomy Bilateral | Status post Subcutaneous Mastectomy Bilateral

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0007099
UMLS CUI [2,2]
C0006141
UMLS CUI [3,1]
C0085076
UMLS CUI [3,2]
C0205253
UMLS CUI [3,3]
C1301732
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1997268
UMLS CUI [4,3]
C0205092
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0024887
UMLS CUI [5,3]
C0205092
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1997268
UMLS CUI [6,3]
C0238767
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C0024887
UMLS CUI [7,3]
C0238767
patient agrees to participate in study and to sign an informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
able and willing to return for all scheduled and required study visits
Description

Clinical Trial Visits Able | Clinical Trial Visits Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0008952
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0008952
UMLS CUI [2,3]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
is a smoker (patient having quit at least 4 weeks prior surgery can be included)
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
bmi <18 or > 30
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
previous radiation therapy to the region at any time
Description

Prior radiation therapy Region Involved

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205147
UMLS CUI [1,3]
C1314939
insulin-dependent diabetes or any immune deficiency requiring immunosuppressant use such as cortisone or biological therapies
Description

Diabetes Mellitus, Insulin-Dependent | Immunodeficiency Requiring Immunosuppressive Agents | Cortisone | Biological treatment

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021081
UMLS CUI [3]
C0010137
UMLS CUI [4]
C1531518
predicted implant size <200 or >600 ml per investigator assessment
Description

Implant Size predicted

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0681842
allergy to porcine
Description

Hypersensitivity Porcine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039005
pregnancy or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
current enrollment or plans to enroll in another clinical trial unless a retrospective study
Description

Study Subject Participation Status | Clinical Trial Except Retrospective Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0035363
neoadjuvant treatment with chemotherapy
Description

Chemotherapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
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Similar models

Eligibility Breast Cancer NCT02061527

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Carcinoma in Situ Breast | Mammaplasty Immediate Planned | Status post Skin sparing mastectomy Unilateral | Status post Subcutaneous Mastectomy Unilateral | Status post Skin sparing mastectomy Bilateral | Status post Subcutaneous Mastectomy Bilateral
Item
patient with invasive or pre-invasive (in situ) breast cancer, planned for immediate breast reconstruction post-skin sparing or nipple sparing mastectomy (unilateral or bilateral)
boolean
C0853879 (UMLS CUI [1])
C0007099 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0085076 (UMLS CUI [3,1])
C0205253 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C1997268 (UMLS CUI [4,2])
C0205092 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0024887 (UMLS CUI [5,2])
C0205092 (UMLS CUI [5,3])
C0231290 (UMLS CUI [6,1])
C1997268 (UMLS CUI [6,2])
C0238767 (UMLS CUI [6,3])
C0231290 (UMLS CUI [7,1])
C0024887 (UMLS CUI [7,2])
C0238767 (UMLS CUI [7,3])
Informed Consent
Item
patient agrees to participate in study and to sign an informed consent form
boolean
C0021430 (UMLS CUI [1])
Clinical Trial Visits Able | Clinical Trial Visits Willing
Item
able and willing to return for all scheduled and required study visits
boolean
C0008976 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Tobacco use
Item
is a smoker (patient having quit at least 4 weeks prior surgery can be included)
boolean
C0543414 (UMLS CUI [1])
Body mass index
Item
bmi <18 or > 30
boolean
C1305855 (UMLS CUI [1])
Prior radiation therapy Region Involved
Item
previous radiation therapy to the region at any time
boolean
C0279134 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent | Immunodeficiency Requiring Immunosuppressive Agents | Cortisone | Biological treatment
Item
insulin-dependent diabetes or any immune deficiency requiring immunosuppressant use such as cortisone or biological therapies
boolean
C0011854 (UMLS CUI [1])
C0021051 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
C0010137 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
Implant Size predicted
Item
predicted implant size <200 or >600 ml per investigator assessment
boolean
C0021102 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0681842 (UMLS CUI [1,3])
Hypersensitivity Porcine
Item
allergy to porcine
boolean
C0020517 (UMLS CUI [1,1])
C0039005 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial Except Retrospective Study
Item
current enrollment or plans to enroll in another clinical trial unless a retrospective study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0035363 (UMLS CUI [2,3])
Chemotherapy Neoadjuvant
Item
neoadjuvant treatment with chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
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