ID

26059

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00536081

Stichworte

Versionen (1)
  1. 05.10.17 05.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Oktober 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT00536081

Englisch

Eligibility Breast Cancer NCT00536081

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Breast Carcinoma | Age

Datentyp

boolean

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

Indication Chemotherapy

Datentyp

boolean

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

Fit Chemotherapy | Renal function | Liver function

Datentyp

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.:
Beschreibung

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

Datentyp

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:
Beschreibung

Regimen Risk Percentage Febrile Neutropenia

Datentyp

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)
Beschreibung

docetaxel | Adriamycin | Cyclophosphamide

Datentyp

boolean

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

Adriamycin | docetaxel

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Prior Chemotherapy

Datentyp

boolean

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

ECOG performance status | Liver Dysfunction Grade

Datentyp

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.
Beschreibung

docetaxel | FEC protocol | Risk Increased Febrile Neutropenia | Elderly

Datentyp

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.
Beschreibung

Protocol Compliance

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
active uncontrolled infection.
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

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

Abnormal renal function | Liver Dysfunction

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Therapy-Related Toxicity | Recovery Lacking

Datentyp

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.
Beschreibung

Absolute neutrophil count | Etiology Bone Marrow Involvement Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1517677
UMLS CUI [2,3]
C0332197
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT00536081

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video