ID

26891

Beskrivning

A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early; ODM derived from: https://clinicaltrials.gov/show/NCT00957125

Länk

https://clinicaltrials.gov/show/NCT00957125

Nyckelord

Versioner (1)
  1. 2017-10-27 2017-10-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00957125

Engelsk

Eligibility Breast Cancer NCT00957125

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
female patients with breast cancer confirmed by histology.
Beskrivning

Gender | Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
tumour and blood samples according to appendix i available.
Beskrivning

Tumor tissue sample Available | Blood specimen Available

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [2,1]
C0178913
UMLS CUI [2,2]
C0470187
age 18 years or older. elderly patients in condition adequate for chemotherapy.
Beskrivning

Age | Elderly Physical Fitness Adequate Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0001792
UMLS CUI [2,2]
C0031812
UMLS CUI [2,3]
C0205411
UMLS CUI [2,4]
C0392920
localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases including ipsilateral supraclavicular nodes with breast cancer diagnosis confirmed by histological examination with or without breast tumour lesions.
Beskrivning

Breast Carcinoma Primary Localized | Inflammatory Breast Carcinoma Suitable First line treatment | Secondary malignant neoplasm of lymph node regional | Secondary malignant neoplasm of supraclavicular lymph nodes Ipsilateral Associated with Breast Carcinoma | Breast Carcinoma Lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0392752
UMLS CUI [2,1]
C0278601
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C1708063
UMLS CUI [3,1]
C0686619
UMLS CUI [3,2]
C0205147
UMLS CUI [4,1]
C0686637
UMLS CUI [4,2]
C0441989
UMLS CUI [4,3]
C0332281
UMLS CUI [4,4]
C0678222
UMLS CUI [5,1]
C0678222
UMLS CUI [5,2]
C0221198
adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders.
Beskrivning

Bone Marrow function | Renal function | Liver function | Cardiac function | Disease Uncontrolled Absent | Mental disorders Uncontrolled Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0232164
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0205318
UMLS CUI [6,3]
C0332197
ecog performance status 0-1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
patients in child-bearing age with adequate contraception.
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
distant metastases, including node metastases in the contralateral breast region and in the mediastina.
Beskrivning

Distant metastasis | Secondary malignant neoplasm of lymph node Region of breast Contralateral | Secondary malignant neoplasm of lymph node Mediastinum

Datatyp

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C0230109
UMLS CUI [2,3]
C0441988
UMLS CUI [3,1]
C0686619
UMLS CUI [3,2]
C0025066
other malignancy for the last two years except for radically treated basal or squamous cell carcinoma of the skin or cis of the cervix.
Beskrivning

Cancer Other | Exception Radical therapy Basal cell carcinoma | Exception Radical therapy Squamous cell carcinoma of skin | Exception Radical therapy Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0260176
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0260176
UMLS CUI [3,3]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0260176
UMLS CUI [4,3]
C0851140
her2-amplification verified by fish analysis.
Beskrivning

HER2 gene amplification FISH

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512127
UMLS CUI [1,2]
C0162789
pregnancy or lactation.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
Beskrivning

Uncontrolled hypertension | Heart Diseases | Liver diseases | Kidney Diseases | Disease | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0012634
UMLS CUI [6]
C0004936
recent history of thromboembolism and ongoing medication with full-dose anticoagulants.
Beskrivning

Thromboembolism | Anticoagulants Dose Full

Datatyp

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0443225
major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment.
Beskrivning

Major surgery | Incisional biopsy | Traumatic injury | Major surgery Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
UMLS CUI [4,1]
C0679637
UMLS CUI [4,2]
C0686904
minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
Beskrivning

Minor Surgical Procedures | Insertion Indwelling Catheter | bevacizumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0038904
UMLS CUI [2,1]
C0021107
UMLS CUI [2,2]
C0007439
UMLS CUI [3]
C0796392
history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
Beskrivning

Congenital bleeding diathesis | Hereditary coagulopathy Associated with Bleeding Risk

Datatyp

boolean

Alias
UMLS CUI [1]
C1856452
UMLS CUI [2,1]
C0679428
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C3251812
non-healing wound, active peptic ulcer or bone fracture.
Beskrivning

non-healing wound | Peptic Ulcer | Bone fracture

Datatyp

boolean

Alias
UMLS CUI [1]
C0750433
UMLS CUI [2]
C0030920
UMLS CUI [3]
C0016658
history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment.
Beskrivning

Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess

Datatyp

boolean

Alias
UMLS CUI [1]
C1879311
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
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Similar models

Eligibility Breast Cancer NCT00957125

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Breast Carcinoma
Item
female patients with breast cancer confirmed by histology.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Tumor tissue sample Available | Blood specimen Available
Item
tumour and blood samples according to appendix i available.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0178913 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
Age | Elderly Physical Fitness Adequate Chemotherapy
Item
age 18 years or older. elderly patients in condition adequate for chemotherapy.
boolean
C0001779 (UMLS CUI [1])
C0001792 (UMLS CUI [2,1])
C0031812 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
Breast Carcinoma Primary Localized | Inflammatory Breast Carcinoma Suitable First line treatment | Secondary malignant neoplasm of lymph node regional | Secondary malignant neoplasm of supraclavicular lymph nodes Ipsilateral Associated with Breast Carcinoma | Breast Carcinoma Lesion
Item
localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases including ipsilateral supraclavicular nodes with breast cancer diagnosis confirmed by histological examination with or without breast tumour lesions.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0392752 (UMLS CUI [1,3])
C0278601 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1708063 (UMLS CUI [2,3])
C0686619 (UMLS CUI [3,1])
C0205147 (UMLS CUI [3,2])
C0686637 (UMLS CUI [4,1])
C0441989 (UMLS CUI [4,2])
C0332281 (UMLS CUI [4,3])
C0678222 (UMLS CUI [4,4])
C0678222 (UMLS CUI [5,1])
C0221198 (UMLS CUI [5,2])
Bone Marrow function | Renal function | Liver function | Cardiac function | Disease Uncontrolled Absent | Mental disorders Uncontrolled Absent
Item
adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
ECOG performance status
Item
ecog performance status 0-1.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
patients in child-bearing age with adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Distant metastasis | Secondary malignant neoplasm of lymph node Region of breast Contralateral | Secondary malignant neoplasm of lymph node Mediastinum
Item
distant metastases, including node metastases in the contralateral breast region and in the mediastina.
boolean
C1269798 (UMLS CUI [1])
C0686619 (UMLS CUI [2,1])
C0230109 (UMLS CUI [2,2])
C0441988 (UMLS CUI [2,3])
C0686619 (UMLS CUI [3,1])
C0025066 (UMLS CUI [3,2])
Cancer Other | Exception Radical therapy Basal cell carcinoma | Exception Radical therapy Squamous cell carcinoma of skin | Exception Radical therapy Carcinoma in situ of uterine cervix
Item
other malignancy for the last two years except for radically treated basal or squamous cell carcinoma of the skin or cis of the cervix.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0260176 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0260176 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0260176 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
HER2 gene amplification FISH
Item
her2-amplification verified by fish analysis.
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Uncontrolled hypertension | Heart Diseases | Liver diseases | Kidney Diseases | Disease | Mental disorders
Item
uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
boolean
C1868885 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0012634 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
Thromboembolism | Anticoagulants Dose Full
Item
recent history of thromboembolism and ongoing medication with full-dose anticoagulants.
boolean
C0040038 (UMLS CUI [1])
C0003280 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443225 (UMLS CUI [2,3])
Major surgery | Incisional biopsy | Traumatic injury | Major surgery Patient need for
Item
major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment.
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0679637 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
Minor Surgical Procedures | Insertion Indwelling Catheter | bevacizumab
Item
minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
boolean
C0038904 (UMLS CUI [1])
C0021107 (UMLS CUI [2,1])
C0007439 (UMLS CUI [2,2])
C0796392 (UMLS CUI [3])
Congenital bleeding diathesis | Hereditary coagulopathy Associated with Bleeding Risk
Item
history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
boolean
C1856452 (UMLS CUI [1])
C0679428 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3251812 (UMLS CUI [2,3])
non-healing wound | Peptic Ulcer | Bone fracture
Item
non-healing wound, active peptic ulcer or bone fracture.
boolean
C0750433 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment.
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
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