ID

41156

Description

Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01240681

Link

https://clinicaltrials.gov/show/NCT01240681

Keywords

Versions (1)
  1. 7/2/20 7/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 2, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Locally Advanced Breast Cancer (LABC) NCT01240681

English

Eligibility Locally Advanced Breast Cancer (LABC) NCT01240681

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic proof of breast cancer (invasive ductal or lobular carcinoma). breast sarcoma and lymphoma are not eligible.
Description

Invasive Ductal Breast Carcinoma | Breast cancer, lobular | Sarcoma of breast Ineligible | Breast Lymphoma Ineligible

Data type

boolean

Alias
UMLS CUI [1]
C1134719
UMLS CUI [2]
C3549742
UMLS CUI [3,1]
C0349667
UMLS CUI [3,2]
C1512714
UMLS CUI [4,1]
C1704251
UMLS CUI [4,2]
C1512714
clinical diagnosis of locally advanced breast cancer (stage iib (t3,n0,m0), stage iiia, iiib, or iiic, according to american joint committee on cancer (ajcc) tumour-node-metastasis (tnm) cancer staging), including inflammatory breast cancer.
Description

Locally advanced breast cancer TNM Breast tumor staging | Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0278601
ability to undergo neoadjuvant chemotherapy.
Description

Neoadjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of metastatic disease (identified on chest x-ray, liver ultrasound, bone scan or other imaging tests);
Description

Neoplasm Metastasis Chest X-ray | Neoplasm Metastasis Ultrasonography of liver | Neoplasm Metastasis Bone scan | Neoplasm Metastasis Diagnostic imaging tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0039985
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0412534
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0203668
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C4718671
previous chemotherapy or hormonal therapy for breast cancer;
Description

Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0678222
significant concurrent medical problems that result in the patient being unfit for surgery (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease);
Description

Medical Problem | Patients unfit Operative Surgical Procedure | Diabetic - poor control | Heart Disease | Severe chronic obstructive pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C1254481
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C3841806
UMLS CUI [2,3]
C0543467
UMLS CUI [3]
C0421258
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0730607
known pregnancy or lactating female (e.g. positive serum beta human chorionic gonadotropin (b-hcg) pregnancy test);
Description

Pregnancy | Breast Feeding | Serum pregnancy test (B-HCG) Positive

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0430060
UMLS CUI [3,2]
C1514241
inability to lie supine for imaging with positron emission tomography (pet);
Description

Lacking Able to lie down Supine | Positron-Emission Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0032743
any contraindication to undergoing magnetic resonance imaging (mri) or pet;
Description

Medical contraindication MRI | Medical contraindication PET

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0032743
currently receiving antabuse;
Description

Antabuse

Data type

boolean

Alias
UMLS CUI [1]
C0591096
inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Description

Informed Consent Unable | Dementia | Impaired cognition Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C0497327
UMLS CUI [3,1]
C0338656
UMLS CUI [3,2]
C0205082
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Similar models

Eligibility Locally Advanced Breast Cancer (LABC) NCT01240681

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive Ductal Breast Carcinoma | Breast cancer, lobular | Sarcoma of breast Ineligible | Breast Lymphoma Ineligible
Item
histologic proof of breast cancer (invasive ductal or lobular carcinoma). breast sarcoma and lymphoma are not eligible.
boolean
C1134719 (UMLS CUI [1])
C3549742 (UMLS CUI [2])
C0349667 (UMLS CUI [3,1])
C1512714 (UMLS CUI [3,2])
C1704251 (UMLS CUI [4,1])
C1512714 (UMLS CUI [4,2])
Locally advanced breast cancer TNM Breast tumor staging | Inflammatory Breast Carcinoma
Item
clinical diagnosis of locally advanced breast cancer (stage iib (t3,n0,m0), stage iiia, iiib, or iiic, according to american joint committee on cancer (ajcc) tumour-node-metastasis (tnm) cancer staging), including inflammatory breast cancer.
boolean
C3495949 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0278601 (UMLS CUI [2])
Neoadjuvant Chemotherapy
Item
ability to undergo neoadjuvant chemotherapy.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Chest X-ray | Neoplasm Metastasis Ultrasonography of liver | Neoplasm Metastasis Bone scan | Neoplasm Metastasis Diagnostic imaging tests
Item
evidence of metastatic disease (identified on chest x-ray, liver ultrasound, bone scan or other imaging tests);
boolean
C0027627 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0412534 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C4718671 (UMLS CUI [4,2])
Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma
Item
previous chemotherapy or hormonal therapy for breast cancer;
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Medical Problem | Patients unfit Operative Surgical Procedure | Diabetic - poor control | Heart Disease | Severe chronic obstructive pulmonary disease
Item
significant concurrent medical problems that result in the patient being unfit for surgery (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease);
boolean
C1254481 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C3841806 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0421258 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0730607 (UMLS CUI [5])
Pregnancy | Breast Feeding | Serum pregnancy test (B-HCG) Positive
Item
known pregnancy or lactating female (e.g. positive serum beta human chorionic gonadotropin (b-hcg) pregnancy test);
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430060 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Lacking Able to lie down Supine | Positron-Emission Tomography
Item
inability to lie supine for imaging with positron emission tomography (pet);
boolean
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0032743 (UMLS CUI [2])
Medical contraindication MRI | Medical contraindication PET
Item
any contraindication to undergoing magnetic resonance imaging (mri) or pet;
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0032743 (UMLS CUI [2,2])
Antabuse
Item
currently receiving antabuse;
boolean
C0591096 (UMLS CUI [1])
Informed Consent Unable | Dementia | Impaired cognition Severe
Item
inability to provide informed consent (e.g. dementia or severe cognitive impairment).
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0497327 (UMLS CUI [2])
C0338656 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
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