ID

20625

Beskrivning

A Prospective Study to Evaluate FDG-PET, Breast MRI, and Breast Ultrasonography in Monitoring Tumour Responses in Patients With Locally Advanced Breast Cancer (LABC) Undergoing Neoadjuvant Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00788489

Länk

https://clinicaltrials.gov/show/NCT00788489

Nyckelord

Versioner (1)
  1. 2017-03-07 2017-03-07 -
Uppladdad den

7 mars 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Locally Advanced Breast Cancer NCT00788489

Engelsk

Eligibility Locally Advanced Breast Cancer NCT00788489

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic proof of breast cancer (invasive ductal or lobular carcinoma - not breast sarcoma or lymphoma)
Beskrivning

histologic proof of breast cancer (invasive ductal or lobular carcinoma)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0679557
UMLS CUI [2]
C1334276
patients having a clinical diagnosis of locally advanced breast cancer (t3 or t4, or n2 according to tnm classification) including inflammatory breast cancer.
Beskrivning

Locally advanced breast cancer; TNM Staging System | Inflammatory Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C1515169
UMLS CUI [2]
C0278601
patients must be able to undergo neoadjuvant chemotherapy.
Beskrivning

neoadjuvant chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 sufficient to undergo chemotherapy
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously treated cancer other than nonmelanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater.
Beskrivning

History of neoplastic disease | Nonmelanoma skin cancer (in some patients) | Carcinoma in situ of uterine cervix | Individual Cancer History; Disease-Free Survival

Datatyp

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2]
C3281209
UMLS CUI [3]
C0851140
UMLS CUI [4,1]
C1512706
UMLS CUI [4,2]
C0242793
evidence of metastatic disease (found on chest x-ray, liver ultrasound or bone scan).
Beskrivning

metastatic disease (found on chest x-ray, liver ultrasound or bone scan)

Datatyp

boolean

Alias
UMLS CUI [1]
C2939420
UMLS CUI [2]
C0039985
UMLS CUI [3]
C0412534
UMLS CUI [4]
C0203668
previous chemotherapy or hormonal therapy for breast cancer.
Beskrivning

previous chemotherapy or hormonal therapy for breast cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0678222
active infection or other significant illnesses which could hamper their ability to tolerate chemotherapy
Beskrivning

Communicable Diseases; Active | Comorbidity | Chemotherapy coping

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
UMLS CUI [2]
C0009488
UMLS CUI [3]
C0742248
significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease) making the patient unfit for surgery.
Beskrivning

Comorbidity | Medically fit for surgery | Diabetic - poor control | Heart Diseases | Severe chronic obstructive pulmonary disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C4075860
UMLS CUI [3]
C0421258
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0730607
any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
Beskrivning

Informed Consent | Comorbidity; Limited (extensiveness); Protocol Compliance | Dementia | Severe cognitive impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
UMLS CUI [3]
C0497327
UMLS CUI [4]
C3554639
pregnant or lactating females (e.g. positive serum b-hcg pregnancy test).
Beskrivning

pregnancy, breast feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unable to lie supine for imaging with pet.
Beskrivning

unable to lie supine for imaging with pet

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0560840
inadequate hematologic, renal and liver function as measured by cbc (wbc < 4.0 x 109, hb < 100 g/l, plt count < 100 x 109), and abnormal hepatic transaminases (ast, alt, ggt, alkaline phosphatase > 2x normal), elevated total bilirubin, and elevated serum creatinine (cr > 110 micromol/l).
Beskrivning

White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gamma glutamyl transferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Creatinine measurement, serum (procedure)

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0202035
UMLS CUI [7]
C0201850
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0201976
any contraindication to undergoing mri or pet.
Beskrivning

any contraindication to undergoing mri or pet

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0032743
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Similar models

Eligibility Locally Advanced Breast Cancer NCT00788489

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
histologic proof of breast cancer (invasive ductal or lobular carcinoma)
Item
histologic proof of breast cancer (invasive ductal or lobular carcinoma - not breast sarcoma or lymphoma)
boolean
C0678222 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C1334276 (UMLS CUI [2])
Locally advanced breast cancer; TNM Staging System | Inflammatory Breast Carcinoma
Item
patients having a clinical diagnosis of locally advanced breast cancer (t3 or t4, or n2 according to tnm classification) including inflammatory breast cancer.
boolean
C3495949 (UMLS CUI [1,1])
C1515169 (UMLS CUI [1,2])
C0278601 (UMLS CUI [2])
neoadjuvant chemotherapy
Item
patients must be able to undergo neoadjuvant chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
ecog
Item
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 sufficient to undergo chemotherapy
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
History of neoplastic disease | Nonmelanoma skin cancer (in some patients) | Carcinoma in situ of uterine cervix | Individual Cancer History; Disease-Free Survival
Item
previously treated cancer other than nonmelanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater.
boolean
C2735088 (UMLS CUI [1])
C3281209 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C1512706 (UMLS CUI [4,1])
C0242793 (UMLS CUI [4,2])
metastatic disease (found on chest x-ray, liver ultrasound or bone scan)
Item
evidence of metastatic disease (found on chest x-ray, liver ultrasound or bone scan).
boolean
C2939420 (UMLS CUI [1])
C0039985 (UMLS CUI [2])
C0412534 (UMLS CUI [3])
C0203668 (UMLS CUI [4])
previous chemotherapy or hormonal therapy for breast cancer
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])
Communicable Diseases; Active | Comorbidity | Chemotherapy coping
Item
active infection or other significant illnesses which could hamper their ability to tolerate chemotherapy
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
C0742248 (UMLS CUI [3])
Comorbidity | Medically fit for surgery | Diabetic - poor control | Heart Diseases | Severe chronic obstructive pulmonary disease
Item
significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease) making the patient unfit for surgery.
boolean
C0009488 (UMLS CUI [1])
C4075860 (UMLS CUI [2])
C0421258 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0730607 (UMLS CUI [5])
Informed Consent | Comorbidity; Limited (extensiveness); Protocol Compliance | Dementia | Severe cognitive impairment
Item
any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
boolean
C0021430 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0497327 (UMLS CUI [3])
C3554639 (UMLS CUI [4])
pregnancy, breast feeding
Item
pregnant or lactating females (e.g. positive serum b-hcg pregnancy test).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
unable to lie supine for imaging with pet
Item
unable to lie supine for imaging with pet.
boolean
C0032743 (UMLS CUI [1,1])
C0560840 (UMLS CUI [1,2])
White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gamma glutamyl transferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Creatinine measurement, serum (procedure)
Item
inadequate hematologic, renal and liver function as measured by cbc (wbc < 4.0 x 109, hb < 100 g/l, plt count < 100 x 109), and abnormal hepatic transaminases (ast, alt, ggt, alkaline phosphatase > 2x normal), elevated total bilirubin, and elevated serum creatinine (cr > 110 micromol/l).
boolean
C0023508 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0202035 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0201976 (UMLS CUI [9])
any contraindication to undergoing mri or pet
Item
any contraindication to undergoing mri or pet.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0032743 (UMLS CUI [2,2])
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