ID

39271

Description

Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Cisplatin; ODM derived from: https://clinicaltrials.gov/show/NCT01957514

Link

https://clinicaltrials.gov/show/NCT01957514

Keywords

Versions (1)
  1. 12/15/19 12/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Estrogen Receptor Negative NCT01957514

English

Eligibility Estrogen Receptor Negative NCT01957514

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients will have metastatic triple negative breast cancer (tnbc) and are about to receive treatment with single agent cisplatin
Description

Triple-Negative Breast Cancer | Cisplatin

Data type

boolean

Alias
UMLS CUI [1]
C2348819
UMLS CUI [2]
C0008838
measurable disease including bone disease as determined by physical exam or imaging
Description

Measurable Disease | Bone Disease | Physical Examination | Imaging

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0005940
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0011923
patients must have tumor suitable for biopsy (as assessed by trained specialists in radiology); patients must be medically fit and willing to undergo repeated tissue biopsies or surgical procedures to get tumor tissue
Description

Neoplasm suitable Biopsy | Patients Fit | Tissue biopsy Tumor tissue sample | Operative Surgical Procedures Tumor tissue sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0424576
UMLS CUI [3,1]
C3864006
UMLS CUI [3,2]
C0475358
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0475358
written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
procedure-specific signed informed consent prior to initiation of any study-related procedures
Description

Informed Consent Procedure Specific

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0205369
eastern cooperative oncology group (ecog) performance status of 0-1 (or a karnofsky performance status of >= 50%)
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
agree to allow their de-identified clinical and laboratory data to be posted to publicly available databases such as database of genotypes and phenotypes (dbgap)
Description

Clinical Data Release Databases

Data type

boolean

Alias
UMLS CUI [1,1]
C1516606
UMLS CUI [1,2]
C1283071
UMLS CUI [1,3]
C0242356
minorities are included in this protocol
Description

Minorities

Data type

boolean

Alias
UMLS CUI [1]
C0026192
patients with a prior history of malignancy remain eligible
Description

History of cancer

Data type

boolean

Alias
UMLS CUI [1]
C0455471
patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible
Description

Neoplastic Syndromes, Hereditary | Medical History Suggestive of Hereditary Neoplastic Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0027672
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C0027672
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
it is at the enrolling study oncologist's discretion to decide if a patient is not fit enough to undergo tissue biopsy; presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
Description

Patient Medically unfit Tissue biopsy | Condition compromises Patient safety | Abnormality compromises Patient safety | Condition compromises Data Quality | Abnormality compromises Data Quality

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C3864006
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C0242483
UMLS CUI [5,1]
C1704258
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C0242483
significant bleeding disorder
Description

Blood Coagulation Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005779
pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
Description

Pregnancy | Breast Feeding | Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0558080
prisoners
Description

Prisoners

Data type

boolean

Alias
UMLS CUI [1]
C0033167
inability to give informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
known brain metastases that haven't been treated
Description

Metastatic malignant neoplasm to brain Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
bevacizumab treatment within 4 weeks prior to biopsy
Description

bevacizumab

Data type

boolean

Alias
UMLS CUI [1]
C0796392
anticoagulation therapy, unless reversed at the time of biopsy
Description

Anticoagulation Therapy | Exception Reversed Anticoagulation

Data type

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2917126
patients with a life expectancy of less than 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
prior treatment with platinum-based chemotherapy for tnbc
Description

Prior Chemotherapy Platinum-Based Triple-Negative Breast Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C2348819
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Similar models

Eligibility Estrogen Receptor Negative NCT01957514

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Triple-Negative Breast Cancer | Cisplatin
Item
patients will have metastatic triple negative breast cancer (tnbc) and are about to receive treatment with single agent cisplatin
boolean
C2348819 (UMLS CUI [1])
C0008838 (UMLS CUI [2])
Measurable Disease | Bone Disease | Physical Examination | Imaging
Item
measurable disease including bone disease as determined by physical exam or imaging
boolean
C1513041 (UMLS CUI [1])
C0005940 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0011923 (UMLS CUI [4])
Neoplasm suitable Biopsy | Patients Fit | Tissue biopsy Tumor tissue sample | Operative Surgical Procedures Tumor tissue sample
Item
patients must have tumor suitable for biopsy (as assessed by trained specialists in radiology); patients must be medically fit and willing to undergo repeated tissue biopsies or surgical procedures to get tumor tissue
boolean
C0027651 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0424576 (UMLS CUI [2,2])
C3864006 (UMLS CUI [3,1])
C0475358 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0475358 (UMLS CUI [4,2])
Informed Consent | Protocol Compliance
Item
written informed consent obtained from subject and ability for subject to comply with the requirements of the study
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Informed Consent Procedure Specific
Item
procedure-specific signed informed consent prior to initiation of any study-related procedures
boolean
C0021430 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group (ecog) performance status of 0-1 (or a karnofsky performance status of >= 50%)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Clinical Data Release Databases
Item
agree to allow their de-identified clinical and laboratory data to be posted to publicly available databases such as database of genotypes and phenotypes (dbgap)
boolean
C1516606 (UMLS CUI [1,1])
C1283071 (UMLS CUI [1,2])
C0242356 (UMLS CUI [1,3])
Minorities
Item
minorities are included in this protocol
boolean
C0026192 (UMLS CUI [1])
History of cancer
Item
patients with a prior history of malignancy remain eligible
boolean
C0455471 (UMLS CUI [1])
Neoplastic Syndromes, Hereditary | Medical History Suggestive of Hereditary Neoplastic Syndrome
Item
patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible
boolean
C0027672 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0027672 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Patient Medically unfit Tissue biopsy | Condition compromises Patient safety | Abnormality compromises Patient safety | Condition compromises Data Quality | Abnormality compromises Data Quality
Item
it is at the enrolling study oncologist's discretion to decide if a patient is not fit enough to undergo tissue biopsy; presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
boolean
C0030705 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C3864006 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0242483 (UMLS CUI [4,3])
C1704258 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0242483 (UMLS CUI [5,3])
Blood Coagulation Disorder
Item
significant bleeding disorder
boolean
C0005779 (UMLS CUI [1])
Pregnancy | Breast Feeding | Contraceptive methods Unwilling
Item
pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Prisoners
Item
prisoners
boolean
C0033167 (UMLS CUI [1])
Informed Consent Unable
Item
inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Untreated
Item
known brain metastases that haven't been treated
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
bevacizumab
Item
bevacizumab treatment within 4 weeks prior to biopsy
boolean
C0796392 (UMLS CUI [1])
Anticoagulation Therapy | Exception Reversed Anticoagulation
Item
anticoagulation therapy, unless reversed at the time of biopsy
boolean
C0003281 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2917126 (UMLS CUI [2,2])
Life Expectancy
Item
patients with a life expectancy of less than 6 months
boolean
C0023671 (UMLS CUI [1])
Prior Chemotherapy Platinum-Based Triple-Negative Breast Cancer
Item
prior treatment with platinum-based chemotherapy for tnbc
boolean
C1514457 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C2348819 (UMLS CUI [1,3])
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