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ID
14793
Beschreibung
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
Stichworte
Versionen (2)
- 28.04.16 28.04.16 -
- 29.04.16 29.04.16 -
Hochgeladen am
28. April 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Eligibility Breast Cancer NCT02324205
Eligibility Breast Cancer NCT02324205
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Breast Cancer NCT02324205
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Gender | Age
Item
women aged 30 years or older (≥30 years old);
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
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])
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])
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])
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])
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])
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 [1,1])
C0013230 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0013230 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
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])
C0524865 (UMLS CUI [1,2])