ID

26059

Beskrivning

Various G-CSF Regimens to Prevent Infection During Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00536081

Länk

https://clinicaltrials.gov/show/NCT00536081

Nyckelord

Versioner (1)
  1. 2017-10-05 2017-10-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00536081

Engelsk

Eligibility Breast Cancer NCT00536081

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast cancer patients ≥18 years.
Beskrivning

Breast Carcinoma | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0001779
indication for 3-weekly chemotherapy.
Beskrivning

Indication Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0392920
considered fit enough to receive chemotherapy, with adequate renal and hepatic function.
Beskrivning

Fit Chemotherapy | Renal function | Liver function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C0392920
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
planned a chemotherapy regime in adjuvant, neo-adjuvant, advanced setting with an increased risk of febrile neutropenia, i.e.:
Beskrivning

Chemotherapy Planned Adjuvant therapy | Chemotherapy Planned Neoadjuvant Therapy | Chemotherapy Planned Advanced disease | Risk Increased Febrile Neutropenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0677850
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0600558
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1301732
UMLS CUI [3,3]
C0679246
UMLS CUI [4,1]
C0035647
UMLS CUI [4,2]
C0205217
UMLS CUI [4,3]
C0746883
regimes with >20% risk of febrile neutropenia:
Beskrivning

Regimen Risk Percentage Febrile Neutropenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C0746883
e.g. tac (docetaxel, adriamycin, cyclophosphamide)
Beskrivning

docetaxel | Adriamycin | Cyclophosphamide

Datatyp

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2]
C0085752
UMLS CUI [3]
C0010583
at (adriamycin, docetaxel)
Beskrivning

Adriamycin | docetaxel

Datatyp

boolean

Alias
UMLS CUI [1]
C0085752
UMLS CUI [2]
C0246415
regimes with 10-20% risk of febrile neutropenia (e.g. ac, doxorubicin and vinorelbine, or docetaxel monotherapy) in the presence of ≥1 patient risk factor (>65 yrs, extensive bone marrow involvement or prior extensive radiotherapy on bone tissue
Beskrivning

Regimen Risk Percentage Febrile Neutropenia | Adriamycin | Cyclophosphamide | Doxorubicin | vinorelbine | docetaxel | Risk factors Quantity | Age | Bone Marrow Involvement Extensive | Therapeutic radiology procedure Extensive Bone Tissue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C0746883
UMLS CUI [2]
C0085752
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0013089
UMLS CUI [5]
C0078257
UMLS CUI [6]
C0246415
UMLS CUI [7,1]
C0035648
UMLS CUI [7,2]
C1265611
UMLS CUI [8]
C0001779
UMLS CUI [9,1]
C1517677
UMLS CUI [9,2]
C0205231
UMLS CUI [10,1]
C1522449
UMLS CUI [10,2]
C0205231
UMLS CUI [10,3]
C0391978
prior chemotherapy
Beskrivning

Prior Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
ecog performance status of 2 or more, grade 2 or higher liver function abnormalities).
Beskrivning

ECOG performance status | Liver Dysfunction Grade

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0441800
that is, patients starting with docetaxel as second part of fec-d are eligible for the last 3 docetaxel cycles, if there is an increased risk of febrile neutropenia, e.g. by elderly age.
Beskrivning

docetaxel | FEC protocol | Risk Increased Febrile Neutropenia | Elderly

Datatyp

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2]
C0060133
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0205217
UMLS CUI [3,3]
C0746883
UMLS CUI [4]
C0001792
able to comply with the protocol.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
written informed consent obtained prior to any study specific screening.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
active uncontrolled infection.
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
inadequate renal or hepatic function.
Beskrivning

Abnormal renal function | Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0086565
any evidence or history of hypersensitivity or other contraindications to g-csf medication.
Beskrivning

Hypersensitivity G-CSF Pharmaceutical Preparations | Medical contraindication G-CSF Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0079459
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0079459
UMLS CUI [2,3]
C0013227
not recovered from acute toxicities of prior therapies.
Beskrivning

Therapy-Related Toxicity | Recovery Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C1710382
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332268
absolute neutrophil count (anc) <1.5 x 109/l, not caused by bone marrow involvement.
Beskrivning

Absolute neutrophil count | Etiology Bone Marrow Involvement Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1517677
UMLS CUI [2,3]
C0332197
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Similar models

Eligibility Breast Cancer NCT00536081

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Age
Item
breast cancer patients ≥18 years.
boolean
C0678222 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Indication Chemotherapy
Item
indication for 3-weekly chemotherapy.
boolean
C3146298 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Fit Chemotherapy | Renal function | Liver function
Item
considered fit enough to receive chemotherapy, with adequate renal and hepatic function.
boolean
C0424576 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Chemotherapy Planned Adjuvant therapy | Chemotherapy Planned Neoadjuvant Therapy | Chemotherapy Planned Advanced disease | Risk Increased Febrile Neutropenia
Item
planned a chemotherapy regime in adjuvant, neo-adjuvant, advanced setting with an increased risk of febrile neutropenia, i.e.:
boolean
C0392920 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0677850 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0679246 (UMLS CUI [3,3])
C0035647 (UMLS CUI [4,1])
C0205217 (UMLS CUI [4,2])
C0746883 (UMLS CUI [4,3])
Regimen Risk Percentage Febrile Neutropenia
Item
regimes with >20% risk of febrile neutropenia:
boolean
C0392920 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0746883 (UMLS CUI [1,4])
docetaxel | Adriamycin | Cyclophosphamide
Item
e.g. tac (docetaxel, adriamycin, cyclophosphamide)
boolean
C0246415 (UMLS CUI [1])
C0085752 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
Adriamycin | docetaxel
Item
at (adriamycin, docetaxel)
boolean
C0085752 (UMLS CUI [1])
C0246415 (UMLS CUI [2])
Regimen Risk Percentage Febrile Neutropenia | Adriamycin | Cyclophosphamide | Doxorubicin | vinorelbine | docetaxel | Risk factors Quantity | Age | Bone Marrow Involvement Extensive | Therapeutic radiology procedure Extensive Bone Tissue
Item
regimes with 10-20% risk of febrile neutropenia (e.g. ac, doxorubicin and vinorelbine, or docetaxel monotherapy) in the presence of ≥1 patient risk factor (>65 yrs, extensive bone marrow involvement or prior extensive radiotherapy on bone tissue
boolean
C0392920 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0746883 (UMLS CUI [1,4])
C0085752 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0013089 (UMLS CUI [4])
C0078257 (UMLS CUI [5])
C0246415 (UMLS CUI [6])
C0035648 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0001779 (UMLS CUI [8])
C1517677 (UMLS CUI [9,1])
C0205231 (UMLS CUI [9,2])
C1522449 (UMLS CUI [10,1])
C0205231 (UMLS CUI [10,2])
C0391978 (UMLS CUI [10,3])
Prior Chemotherapy
Item
prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
ECOG performance status | Liver Dysfunction Grade
Item
ecog performance status of 2 or more, grade 2 or higher liver function abnormalities).
boolean
C1520224 (UMLS CUI [1])
C0086565 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
docetaxel | FEC protocol | Risk Increased Febrile Neutropenia | Elderly
Item
that is, patients starting with docetaxel as second part of fec-d are eligible for the last 3 docetaxel cycles, if there is an increased risk of febrile neutropenia, e.g. by elderly age.
boolean
C0246415 (UMLS CUI [1])
C0060133 (UMLS CUI [2])
C0035647 (UMLS CUI [3,1])
C0205217 (UMLS CUI [3,2])
C0746883 (UMLS CUI [3,3])
C0001792 (UMLS CUI [4])
Protocol Compliance
Item
able to comply with the protocol.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
written informed consent obtained prior to any study specific screening.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Uncontrolled
Item
active uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Abnormal renal function | Liver Dysfunction
Item
inadequate renal or hepatic function.
boolean
C0151746 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Hypersensitivity G-CSF Pharmaceutical Preparations | Medical contraindication G-CSF Pharmaceutical Preparations
Item
any evidence or history of hypersensitivity or other contraindications to g-csf medication.
boolean
C0020517 (UMLS CUI [1,1])
C0079459 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0079459 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Therapy-Related Toxicity | Recovery Lacking
Item
not recovered from acute toxicities of prior therapies.
boolean
C1710382 (UMLS CUI [1])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Absolute neutrophil count | Etiology Bone Marrow Involvement Absent
Item
absolute neutrophil count (anc) <1.5 x 109/l, not caused by bone marrow involvement.
boolean
C0948762 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C1517677 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
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