ID

14804

Description

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT); ODM derived from: https://clinicaltrials.gov/show/NCT02324205

Link

https://clinicaltrials.gov/show/NCT02324205

Keywords

Versions (2)
  1. 4/28/16 4/28/16 -
  2. 4/29/16 4/29/16 -
Uploaded on

April 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02324205

English

Eligibility Breast Cancer NCT02324205

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged 30 years or older (≥30 years old);
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
initially asymptomatic women who underwent routine screening ffdm, breast ultrasound (u/s), breast magnetic resonance imaging (mri) and/or dbt, followed by diagnostic work-up showing one of more abnormalities and referred for breast biopsy within of 30 days before study entry 2;
Description

Gender Asymptomatic | full field digital mammogram | Ultrasonography, Mammary | Magnetic resonance imaging of breast | Digital breast tomosynthesis | work up Abnormality | Biopsy of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0231221
UMLS CUI [2]
C3862913
UMLS CUI [3]
C0080264
UMLS CUI [4]
C0344104
UMLS CUI [5]
C3472347
UMLS CUI [6,1]
C0750430
UMLS CUI [6,2]
C1704258
UMLS CUI [7]
C0405352
are able and willing to comply with study procedures;
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
have signed and dated the informed consent form;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
are either surgically sterile or post-menopausal3 or, if of childbearing potential, the possibility of pregnancy is remote based on a documented negative patient history and, optionally, has a negative urine pregnancy test (if subject requests one).
Description

Infertility Operative Surgical Procedures | Postmenopausal state | Childbearing Potential | Pregnancy | Patient History Negative | Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0021359
UMLS CUI [1,2]
C0543467
UMLS CUI [2]
C0232970
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0032961
UMLS CUI [5,1]
C0679831
UMLS CUI [5,2]
C0205160
UMLS CUI [6]
C0430057
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have been previously included in this study;
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
have a history of any symptoms and/or physical signs of breast cancer in either breast (or if she has had a mastectomy, have signs or symptoms of breast cancer in the remaining breast);
Description

Symptoms | Physical findings | Breast Carcinoma | Mastectomy | Sign or Symptom Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2]
C0311392
UMLS CUI [3]
C0678222
UMLS CUI [4]
C0024881
UMLS CUI [5,1]
C3540840
UMLS CUI [5,2]
C0678222
have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) ffdm digital receptor without anatomical cut off during a dbt examination (or ffdm, if required);
Description

problem with female breast size | full field digital mammogram | Digital breast tomosynthesis

Data type

boolean

Alias
UMLS CUI [1]
C0850669
UMLS CUI [2]
C3862913
UMLS CUI [3]
C3472347
have participated in (within the prior 30 days), another trial of an investigational product expected to interfere with study procedures or outcomes;
Description

Study Subject Participation Status | Investigational New Drugs Affecting research results

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0683954
have breast implant(s);
Description

Breast Prosthesis, Internal

Data type

boolean

Alias
UMLS CUI [1]
C0179412
have reconstructed breast(s).
Description

Female breast Reconstructive Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0222603
UMLS CUI [1,2]
C0524865
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Similar models

Eligibility Breast Cancer NCT02324205

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women aged 30 years or older (≥30 years old);
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender Asymptomatic | full field digital mammogram | Ultrasonography, Mammary | Magnetic resonance imaging of breast | Digital breast tomosynthesis | work up Abnormality | Biopsy of breast
Item
initially asymptomatic women who underwent routine screening ffdm, breast ultrasound (u/s), breast magnetic resonance imaging (mri) and/or dbt, followed by diagnostic work-up showing one of more abnormalities and referred for breast biopsy within of 30 days before study entry 2;
boolean
C0079399 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C3862913 (UMLS CUI [2])
C0080264 (UMLS CUI [3])
C0344104 (UMLS CUI [4])
C3472347 (UMLS CUI [5])
C0750430 (UMLS CUI [6,1])
C1704258 (UMLS CUI [6,2])
C0405352 (UMLS CUI [7])
Compliance behavior
Item
are able and willing to comply with study procedures;
boolean
C1321605 (UMLS CUI [1])
Informed Consent
Item
have signed and dated the informed consent form;
boolean
C0021430 (UMLS CUI [1])
Infertility Operative Surgical Procedures | Postmenopausal state | Childbearing Potential | Pregnancy | Patient History Negative | Urine pregnancy test negative
Item
are either surgically sterile or post-menopausal3 or, if of childbearing potential, the possibility of pregnancy is remote based on a documented negative patient history and, optionally, has a negative urine pregnancy test (if subject requests one).
boolean
C0021359 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0679831 (UMLS CUI [5,1])
C0205160 (UMLS CUI [5,2])
C0430057 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
have been previously included in this study;
boolean
C2348568 (UMLS CUI [1])
Symptoms | Physical findings | Breast Carcinoma | Mastectomy | Sign or Symptom Breast Carcinoma
Item
have a history of any symptoms and/or physical signs of breast cancer in either breast (or if she has had a mastectomy, have signs or symptoms of breast cancer in the remaining breast);
boolean
C1457887 (UMLS CUI [1])
C0311392 (UMLS CUI [2])
C0678222 (UMLS CUI [3])
C0024881 (UMLS CUI [4])
C3540840 (UMLS CUI [5,1])
C0678222 (UMLS CUI [5,2])
problem with female breast size | full field digital mammogram | Digital breast tomosynthesis
Item
have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) ffdm digital receptor without anatomical cut off during a dbt examination (or ffdm, if required);
boolean
C0850669 (UMLS CUI [1])
C3862913 (UMLS CUI [2])
C3472347 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs Affecting research results
Item
have participated in (within the prior 30 days), another trial of an investigational product expected to interfere with study procedures or outcomes;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Breast Prosthesis, Internal
Item
have breast implant(s);
boolean
C0179412 (UMLS CUI [1])
Female breast Reconstructive Surgical Procedures
Item
have reconstructed breast(s).
boolean
C0222603 (UMLS CUI [1,1])
C0524865 (UMLS CUI [1,2])
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