Eligibility Breast Cancer NCT00606931

1 Formulários

StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT00606931

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

individuals aged 25 years or older

boolean

C0001779 (UMLS CUI [1])

Breast Imaging finding Quantity | Biopsy Patient need for

Item

individuals who have at least one breast imaging finding requiring biopsy, specifically:

boolean

C0006141 (UMLS CUI [1,1])
C1287399 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])

Item

individuals who have a breast abnormality(ies) moderately suspicious for or highly suggestive of malignancy on imaging with mammography, ultrasound, or mri (as per acr birads™ 4c or 5) and requiring biopsy confirmation or o individuals with known breast cancer who have additional imaging abnormality(ies) suspicious for malignancy detected on a high-resolution fdg pet scan

boolean

C4025829 (UMLS CUI [1,1])
C4050405 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C4025829 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C0011923 (UMLS CUI [2,4])
C0024671 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C1511314 (UMLS CUI [6])
C0005558 (UMLS CUI [7,1])
C0686904 (UMLS CUI [7,2])
C0678222 (UMLS CUI [8])
C3641247 (UMLS CUI [9])

Imaging Work up | Abnormality of the breast Mammography

Item

individuals who had recent conventional imaging work-up including x-ray mammography of the breast containing the abnormality of interest.

boolean

C0011923 (UMLS CUI [1,1])
C0750430 (UMLS CUI [1,2])
C4025829 (UMLS CUI [2,1])
C0024671 (UMLS CUI [2,2])

Item

individuals with suspected tumor size measuring one cm or less on mammography and/or ultrasound and/or mri if the lesion is visible on any of these modalities, except that each site may enroll up to three patients each where the lesion of interest as measured on mammography (or ultrasound and/or mri if not detectable on mammography) is more than 1 cm. (note: the study will target patient enrollment such that at least 50% of the lesions to undergo biopsy across all sites will be less than 1 cm in diameter as measured on mammography, or as measured by other modalities, such as ultrasound, ct, or mri, if the lesion is not detectable or measurable on mammography.)

boolean

C0475440 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0024671 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0005558 (UMLS CUI [5])
C0040405 (UMLS CUI [6])

Study Subject Participation Status Agreement | Informed Consent

Item

individuals who have agreed to participate in the study and who have signed study-specific informed consent

boolean

C2348568 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Pregnancy | Possible pregnancy

Item

women who are or may be pregnant

boolean

C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])

Breast Feeding | Breast Feeding Discontinued Recently

Item

women who are currently lactating or discontinued breastfeeding < 2 months prior to the study

boolean

C0006147 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])

Age

Item

age less than 25 years

boolean

C0001779 (UMLS CUI [1])

Breast implant | Breast Containing Lesion

Item

individuals with breast implant(s) in the breast containing the lesion of interest

boolean

C0179412 (UMLS CUI [1])
C0006141 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])

Sentinel Lymph Node Biopsy Tc-99m Scheduled | PET Biopsy

Item

individuals who are scheduled for a sentinel node procedure using radioactive tc-99m within 24 hours of pet-guided biopsy

boolean

C0796693 (UMLS CUI [1,1])
C0303611 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0032743 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])

Medical contraindication Core biopsy | Medical contraindication Invasive procedure | Blood Coagulation Disorders | Communicable Disease | Anticoagulants Discontinue Unwilling

Item

patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure

boolean

C1301624 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C4048276 (UMLS CUI [2,2])
C0005779 (UMLS CUI [3])
C0009450 (UMLS CUI [4])
C0003280 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Item

individuals with type i or poorly controlled type ii diabetes mellitus

boolean

C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])

Blood glucose measurement | Positron Emission Mammography

Item

individuals with a blood glucose level that is above 140 mg/dl at the time of pem imaging

boolean

C0392201 (UMLS CUI [1])
C3897879 (UMLS CUI [2])

Informed Consent Unable

Item

inability to provide informed consent

boolean

C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

Operative Surgical Procedure Breast Involved

Item

individuals who have had surgery on the study breast(s) within the past 12 months

boolean

C0543467 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])

Voltar ao início da página

ID

Descrição

Link

Palavras-chave

Versões (1)

Titular dos direitos

Transferido a

DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

Eligibility Breast Cancer NCT00606931