ID

14873

Description

Study of Tumor RNA Disruption Assay™ (RDA); ODM derived from: https://clinicaltrials.gov/show/NCT02239315

Link

https://clinicaltrials.gov/show/NCT02239315

Keywords

Versions (1)
  1. 5/2/16 5/2/16 -
Uploaded on

May 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02239315

English

Eligibility Breast Neoplasms NCT02239315

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female,18 years or older;
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
able to read and write in english:
Description

Able to read English Language | Able to write English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
with palpable cancer > 2cm (t2, t3) on clinical examination or clinical diagnosis of locally advanced breast cancer (labc) (t3 or t4; or n2 or n3, according to tnm cancer staging including inflammatory breast cancer);
Description

Malignant Neoplasms Palpable Clinical examination | Locally advanced breast cancer Malignant neoplasm of breast TNM staging | Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0522499
UMLS CUI [1,3]
C1456356
UMLS CUI [2,1]
C3495949
UMLS CUI [2,2]
C2216703
UMLS CUI [3]
C0278601
must have histological proof of breast cancer (invasive ductal or infiltrating lobular);
Description

Invasive Ductal Breast Carcinoma | Carcinoma, Lobular | Histologic Proven findings

Data type

boolean

Alias
UMLS CUI [1]
C1134719
UMLS CUI [2]
C0206692
UMLS CUI [3,1]
C0205462
UMLS CUI [3,2]
C0456369
scheduled to receive neoadjuvant chemotherapy as part of their treatment plan;
Description

Treatment Plan Neoadjuvant Therapy Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0599880
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C3665472
agree to have fnab after the first, second and third cycle of chemotherapy, and if the chemotherapy regimen is changed, an additional fnab after the first cycle of the new chemotherapy.
Description

Agree Fine needle aspiration biopsy | Chemotherapy Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C3641827
UMLS CUI [1,2]
C1510483
UMLS CUI [2]
C0392920
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have had surgery, neoadjuvant chemotherapy or radiotherapy for the current breast cancer;
Description

Operative Surgical Procedures Breast Carcinoma | Neoadjuvant Therapy Chemotherapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [2,3]
C0678222
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0678222
subjects who are pregnant or breast feeding;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects with stage iv breast cancer;
Description

Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1]
C0278488
psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial.
Description

Mental disorders | Substance Use Disorders | Compliance behavior Limited | Unable Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
UMLS CUI [4,1]
C1299582
UMLS CUI [4,2]
C0021430
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Similar models

Eligibility Breast Neoplasms NCT02239315

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female,18 years or older;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Able to read English Language | Able to write English Language
Item
able to read and write in english:
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Malignant Neoplasms Palpable Clinical examination | Locally advanced breast cancer Malignant neoplasm of breast TNM staging | Inflammatory Breast Carcinoma
Item
with palpable cancer > 2cm (t2, t3) on clinical examination or clinical diagnosis of locally advanced breast cancer (labc) (t3 or t4; or n2 or n3, according to tnm cancer staging including inflammatory breast cancer);
boolean
C0006826 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C3495949 (UMLS CUI [2,1])
C2216703 (UMLS CUI [2,2])
C0278601 (UMLS CUI [3])
Invasive Ductal Breast Carcinoma | Carcinoma, Lobular | Histologic Proven findings
Item
must have histological proof of breast cancer (invasive ductal or infiltrating lobular);
boolean
C1134719 (UMLS CUI [1])
C0206692 (UMLS CUI [2])
C0205462 (UMLS CUI [3,1])
C0456369 (UMLS CUI [3,2])
Treatment Plan Neoadjuvant Therapy Chemotherapy
Item
scheduled to receive neoadjuvant chemotherapy as part of their treatment plan;
boolean
C0599880 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
Agree Fine needle aspiration biopsy | Chemotherapy Regimen
Item
agree to have fnab after the first, second and third cycle of chemotherapy, and if the chemotherapy regimen is changed, an additional fnab after the first cycle of the new chemotherapy.
boolean
C3641827 (UMLS CUI [1,1])
C1510483 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedures Breast Carcinoma | Neoadjuvant Therapy Chemotherapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma
Item
subjects who have had surgery, neoadjuvant chemotherapy or radiotherapy for the current breast cancer;
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
subjects who are pregnant or breast feeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Carcinoma breast stage IV
Item
subjects with stage iv breast cancer;
boolean
C0278488 (UMLS CUI [1])
Mental disorders | Substance Use Disorders | Compliance behavior Limited | Unable Informed Consent
Item
psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial.
boolean
C0004936 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C1299582 (UMLS CUI [4,1])
C0021430 (UMLS CUI [4,2])
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