ID

40458

Description

RNA Disruption Assay (RDA) Response Prediction in Neoadjuvant Chemotherapy Breast Cancer Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT02190227

Link

https://clinicaltrials.gov/show/NCT02190227

Keywords

Versions (1)
  1. 4/23/20 4/23/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 23, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Invasive Breast Cancer NCT02190227

English

Eligibility Invasive Breast Cancer NCT02190227

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be female.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
patients must be 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with stage i, ii, or iii breast cancer that is greater or equal to 2 cm on clinical examination.
Description

Breast Carcinoma Size TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0474926
patients that have biopsy proven invasive breast cancer diagnosed by core needle biopsy
Description

Invasive carcinoma of breast Core needle biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1318309
patients who are chemotherapy and radiotherapy naïve for the treatment of the current breast cancer.
Description

Chemotherapy Absent Breast Carcinoma | Therapeutic radiology procedure Absent Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0678222
patients that accept to undergo neoadjuvant chemotherapy.
Description

Chemotherapy Neo-adjuvant Accepted

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1298676
UMLS CUI [1,3]
C1272684
patients with bilateral breast cancer are eligible.
Description

Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
patients that understand, accept, and have signed the approved written consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients will need to consent to be part of the study.
Description

Study Subject Participation Status | Patient need for Consent

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1511481
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with one or more of the following conditions are ineligible for this study:
Description

Condition Quantity Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1512714
patients who have had previous surgery, chemotherapy or radiotherapy for the current breast cancer
Description

Prior surgery Breast Carcinoma | Prior Chemotherapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0678222
patients who are pregnant or breast feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
psychiatric or addictive disorders or conditions or social factors that may preclude the patient from meeting study requirements.
Description

Mental disorders Exclude Protocol Compliance | Addictive Behavior Excludes Protocol Compliance | Condition Excludes Protocol Compliance | Social factor Excludes Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0337460
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0525058
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Similar models

Eligibility Invasive Breast Cancer NCT02190227

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
patients must be female.
boolean
C0079399 (UMLS CUI [1])
Age
Item
patients must be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma Size TNM Breast tumor staging
Item
patients with stage i, ii, or iii breast cancer that is greater or equal to 2 cm on clinical examination.
boolean
C0678222 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Invasive carcinoma of breast Core needle biopsy
Item
patients that have biopsy proven invasive breast cancer diagnosed by core needle biopsy
boolean
C0853879 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
Chemotherapy Absent Breast Carcinoma | Therapeutic radiology procedure Absent Breast Carcinoma
Item
patients who are chemotherapy and radiotherapy naïve for the treatment of the current breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Chemotherapy Neo-adjuvant Accepted
Item
patients that accept to undergo neoadjuvant chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C1298676 (UMLS CUI [1,2])
C1272684 (UMLS CUI [1,3])
Bilateral breast cancer
Item
patients with bilateral breast cancer are eligible.
boolean
C0281267 (UMLS CUI [1])
Informed Consent
Item
patients that understand, accept, and have signed the approved written consent form.
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status | Patient need for Consent
Item
patients will need to consent to be part of the study.
boolean
C2348568 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C1511481 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Condition Quantity Ineligible
Item
patients with one or more of the following conditions are ineligible for this study:
boolean
C0348080 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
Prior surgery Breast Carcinoma | Prior Chemotherapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma
Item
patients who have had previous surgery, chemotherapy or radiotherapy for the current breast cancer
boolean
C0455610 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
patients who are pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorders Exclude Protocol Compliance | Addictive Behavior Excludes Protocol Compliance | Condition Excludes Protocol Compliance | Social factor Excludes Protocol Compliance
Item
psychiatric or addictive disorders or conditions or social factors that may preclude the patient from meeting study requirements.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0337460 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
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