ID

15687

Beschreibung

Immune Boost In Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02319408

Link

https://clinicaltrials.gov/show/NCT02319408

Stichworte

Versionen (1)
  1. 08.06.16 08.06.16 -
Hochgeladen am

8. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02319408

Englisch

Eligibility Non-small Cell Lung Cancer NCT02319408

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven clinical stage i to iia pulmonary adenocarcinoma
Beschreibung

Adenocarcinoma of lung

Datentyp

boolean

Alias
UMLS CUI [1]
C0152013
lung tumor is felt to be curatively resectable by the treating physicians
Beschreibung

Lung Neoplasm Resectable Curative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024121
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C1880198
sufficient pulmonary function for lobectomy according to current guidelines
Beschreibung

Pulmonary function Sufficient Lobectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0023928
the patient is free of distant metastases as confirmed by contrast-enhanced chest and upper abdomen ct-scan and by contrast-enhanced ct or mri of the brain
Beschreibung

Status of distant metastasis Free of | X-Ray Computed Tomography Dynamic Enhanced CT Chest | X-Ray Computed Tomography Dynamic Enhanced CT upper abdomen | X-Ray Computed Tomography Dynamic Enhanced CT Brain | Contrast-enhanced Magnetic Resonance Imaging Brain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302548
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0040405
UMLS CUI [2,2]
C1512095
UMLS CUI [2,3]
C0817096
UMLS CUI [3,1]
C0040405
UMLS CUI [3,2]
C1512095
UMLS CUI [3,3]
C1284917
UMLS CUI [4,1]
C0040405
UMLS CUI [4,2]
C1512095
UMLS CUI [4,3]
C0006104
UMLS CUI [5,1]
C1707501
UMLS CUI [5,2]
C0006104
age over 50years at the time of consent due to federal radiation protection law
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
in female patients of childbearing potential there must be a negative pregnancy test
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
eastern cooperative oncology group performance status of 0,1, 2 or 3 at the time of randomization
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
patients who the investigator believes can and will comply with the requirements of this protocol
Beschreibung

Compliance behavior Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
written informed consent according to good clinical practise and national/regional regulations
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient shows clinical signs of pneumonia
Beschreibung

Pneumonia Sign or Symptom

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C3540840
the patient receives immunosuppressive drugs (alkylating agents, antimetabolites, methotrexate, azathioprine, mercaptopurine, cytotoxic antibodies, ciclosporin, tacrolimus, sirolimus, interferon, mycophenolate, small biological agents)
Beschreibung

Immunosuppressive Agents | Alkylating Agents | Antimetabolites | Methotrexate | Azathioprine | mercaptopurine | Lymphocytotoxic Antibodies | Cyclosporine | Tacrolimus | Sirolimus | Interferon | MYCOPHENOLATE | Biological Agents Small

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0002073
UMLS CUI [3]
C0003376
UMLS CUI [4]
C0025677
UMLS CUI [5]
C0004482
UMLS CUI [6]
C0000618
UMLS CUI [7]
C0024284
UMLS CUI [8]
C0010592
UMLS CUI [9]
C0085149
UMLS CUI [10]
C0072980
UMLS CUI [11]
C3652465
UMLS CUI [12]
C0883242
UMLS CUI [13,1]
C0005515
UMLS CUI [13,2]
C0700321
the patient has been diagnosed with a potential immune mediated disease
Beschreibung

Immune System Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0021053
elevated blood leukocyte count or erythrocyte sedimentation rate
Beschreibung

Elevated white blood cell count | Elevated erythrocyte sedimentation rate

Datentyp

boolean

Alias
UMLS CUI [1]
C1719336
UMLS CUI [2]
C1867037
pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
the patient has received any cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy or chemotherapy
Beschreibung

cancer treatment | Therapeutic radiology procedure | Immunotherapy | Hormone Therapy | Chemotherapy Regimen

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0392920
the patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years
Beschreibung

Malignant Neoplasm Simultaneous | Malignant Neoplasm Medical History | Malignant Neoplasm In complete remission

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0521115
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0677874
the patient needs chronic long term oxygen therapy
Beschreibung

Long-term oxygen therapy chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0418996
UMLS CUI [1,2]
C0205191
the patient has undergone splenectomy
Beschreibung

Splenectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0037995
the patient is known to be hiv positive
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
the patient has an uncontrolled bleeding disorder
Beschreibung

Bleeding uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C3842135
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer NCT02319408

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of lung
Item
histologically proven clinical stage i to iia pulmonary adenocarcinoma
boolean
C0152013 (UMLS CUI [1])
Lung Neoplasm Resectable Curative
Item
lung tumor is felt to be curatively resectable by the treating physicians
boolean
C0024121 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C1880198 (UMLS CUI [1,3])
Pulmonary function Sufficient Lobectomy
Item
sufficient pulmonary function for lobectomy according to current guidelines
boolean
C0231921 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0023928 (UMLS CUI [1,3])
Status of distant metastasis Free of | X-Ray Computed Tomography Dynamic Enhanced CT Chest | X-Ray Computed Tomography Dynamic Enhanced CT upper abdomen | X-Ray Computed Tomography Dynamic Enhanced CT Brain | Contrast-enhanced Magnetic Resonance Imaging Brain
Item
the patient is free of distant metastases as confirmed by contrast-enhanced chest and upper abdomen ct-scan and by contrast-enhanced ct or mri of the brain
boolean
C1302548 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2,1])
C1512095 (UMLS CUI [2,2])
C0817096 (UMLS CUI [2,3])
C0040405 (UMLS CUI [3,1])
C1512095 (UMLS CUI [3,2])
C1284917 (UMLS CUI [3,3])
C0040405 (UMLS CUI [4,1])
C1512095 (UMLS CUI [4,2])
C0006104 (UMLS CUI [4,3])
C1707501 (UMLS CUI [5,1])
C0006104 (UMLS CUI [5,2])
Age
Item
age over 50years at the time of consent due to federal radiation protection law
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
in female patients of childbearing potential there must be a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group performance status of 0,1, 2 or 3 at the time of randomization
boolean
C1520224 (UMLS CUI [1])
Compliance behavior Study Protocol
Item
patients who the investigator believes can and will comply with the requirements of this protocol
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed consent
Item
written informed consent according to good clinical practise and national/regional regulations
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pneumonia Sign or Symptom
Item
the patient shows clinical signs of pneumonia
boolean
C0032285 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
Immunosuppressive Agents | Alkylating Agents | Antimetabolites | Methotrexate | Azathioprine | mercaptopurine | Lymphocytotoxic Antibodies | Cyclosporine | Tacrolimus | Sirolimus | Interferon | MYCOPHENOLATE | Biological Agents Small
Item
the patient receives immunosuppressive drugs (alkylating agents, antimetabolites, methotrexate, azathioprine, mercaptopurine, cytotoxic antibodies, ciclosporin, tacrolimus, sirolimus, interferon, mycophenolate, small biological agents)
boolean
C0021081 (UMLS CUI [1])
C0002073 (UMLS CUI [2])
C0003376 (UMLS CUI [3])
C0025677 (UMLS CUI [4])
C0004482 (UMLS CUI [5])
C0000618 (UMLS CUI [6])
C0024284 (UMLS CUI [7])
C0010592 (UMLS CUI [8])
C0085149 (UMLS CUI [9])
C0072980 (UMLS CUI [10])
C3652465 (UMLS CUI [11])
C0883242 (UMLS CUI [12])
C0005515 (UMLS CUI [13,1])
C0700321 (UMLS CUI [13,2])
Immune System Diseases
Item
the patient has been diagnosed with a potential immune mediated disease
boolean
C0021053 (UMLS CUI [1])
Elevated white blood cell count | Elevated erythrocyte sedimentation rate
Item
elevated blood leukocyte count or erythrocyte sedimentation rate
boolean
C1719336 (UMLS CUI [1])
C1867037 (UMLS CUI [2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
cancer treatment | Therapeutic radiology procedure | Immunotherapy | Hormone Therapy | Chemotherapy Regimen
Item
the patient has received any cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy or chemotherapy
boolean
C0920425 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
Malignant Neoplasm Simultaneous | Malignant Neoplasm Medical History | Malignant Neoplasm In complete remission
Item
the patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years
boolean
C0006826 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0677874 (UMLS CUI [3,2])
Long-term oxygen therapy chronic
Item
the patient needs chronic long term oxygen therapy
boolean
C0418996 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Splenectomy
Item
the patient has undergone splenectomy
boolean
C0037995 (UMLS CUI [1])
HIV Seropositivity
Item
the patient is known to be hiv positive
boolean
C0019699 (UMLS CUI [1])
Bleeding uncontrolled
Item
the patient has an uncontrolled bleeding disorder
boolean
C3842135 (UMLS CUI [1])
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