ID

26010

Beskrivning

Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland; ODM derived from: https://clinicaltrials.gov/show/NCT01630226

Länk

https://clinicaltrials.gov/show/NCT01630226

Nyckelord

Versioner (2)
  1. 2017-10-02 2017-10-02 -
  2. 2017-10-04 2017-10-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility BRCA1 Mutation NCT01630226

Engelsk

Eligibility BRCA1 Mutation NCT01630226

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
Beskrivning

Inclusion criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
1. histologically or cytologically proven diagnosis of invasive breast cancer (stage i-iii).
Beskrivning

Invasive carcinoma of breast TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C3258246
2. documentation of the presence of a germ-line brca1 mutation
Beskrivning

BRCA1 Germ-Line Mutation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376571
UMLS CUI [1,2]
C0206530
3. measurable disease of any size by mammography or ultrasound.
Beskrivning

Measurable Disease Size Mammography | Measurable Disease Size Ultrasonography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0024671
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C0041618
4. female diagnosed with breast cancer between the ages of 20 to 70.
Beskrivning

Gender | Breast Carcinoma | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0001779
5. eastern cooperative oncology group [ecog] performance status of 0 and 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
6. evidence of adequate organ function (liver, bone marrow, kidney)
Beskrivning

Liver function | Bone Marrow function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232804
7. signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrolment.
Beskrivning

Informed Consent | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
8. willingness and ability to comply with scheduled visits, treatment plans laboratory tests, and other study procedures.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
9. polish resident.
Beskrivning

Resident Polish

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347958
UMLS CUI [1,2]
C0220896
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients presenting with any of the following will not be included in the trial:
Beskrivning

Exclusion Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1550543
1. previous chemotherapy for current cancer.
Beskrivning

Prior Chemotherapy Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0006826
2. previous or current diagnosis of any other malignancy except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
3. receiving any medication that may markedly affect renal function.
Beskrivning

Pharmaceutical Preparations Affecting Renal function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0232804
4. pregnant or breastfeeding women.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
Beskrivning

Comorbidity Uncontrolled Protocol Compliance Limited | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0525058
UMLS CUI [1,4]
C0439801
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0004936
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Similar models

Eligibility BRCA1 Mutation NCT01630226

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Fulfill
Item
patients must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Invasive carcinoma of breast TNM clinical staging
Item
1. histologically or cytologically proven diagnosis of invasive breast cancer (stage i-iii).
boolean
C0853879 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
BRCA1 Germ-Line Mutation
Item
2. documentation of the presence of a germ-line brca1 mutation
boolean
C0376571 (UMLS CUI [1,1])
C0206530 (UMLS CUI [1,2])
Measurable Disease Size Mammography | Measurable Disease Size Ultrasonography
Item
3. measurable disease of any size by mammography or ultrasound.
boolean
C1513041 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
Gender | Breast Carcinoma | Age
Item
4. female diagnosed with breast cancer between the ages of 20 to 70.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
ECOG performance status
Item
5. eastern cooperative oncology group [ecog] performance status of 0 and 1.
boolean
C1520224 (UMLS CUI [1])
Liver function | Bone Marrow function | Renal function
Item
6. evidence of adequate organ function (liver, bone marrow, kidney)
boolean
C0232741 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3])
Informed Consent | Informed Consent Patient Representative
Item
7. signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrolment.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Protocol Compliance
Item
8. willingness and ability to comply with scheduled visits, treatment plans laboratory tests, and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Resident Polish
Item
9. polish resident.
boolean
C2347958 (UMLS CUI [1,1])
C0220896 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Fulfill
Item
patients presenting with any of the following will not be included in the trial:
boolean
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Prior Chemotherapy Malignant Neoplasms
Item
1. previous chemotherapy for current cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
2. previous or current diagnosis of any other malignancy except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Pharmaceutical Preparations Affecting Renal function
Item
3. receiving any medication that may markedly affect renal function.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0232804 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
4. pregnant or breastfeeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Uncontrolled Protocol Compliance Limited | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders
Item
5. uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
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