ID

15687

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02319408

Palabras clave

Versiones (1)
  1. 8/6/16 8/6/16 -
Subido en

8 de junio de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Non-small Cell Lung Cancer NCT02319408

Inglés

Eligibility Non-small Cell Lung Cancer NCT02319408

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Adenocarcinoma of lung

Tipo de datos

boolean

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

Lung Neoplasm Resectable Curative

Tipo de datos

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
Descripción

Pulmonary function Sufficient Lobectomy

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Age

Tipo de datos

boolean

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

Childbearing Potential Pregnancy test negative

Tipo de datos

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
Descripción

ECOG performance status

Tipo de datos

boolean

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

Compliance behavior Study Protocol

Tipo de datos

boolean

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

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Pneumonia Sign or Symptom

Tipo de datos

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)
Descripción

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

Tipo de datos

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
Descripción

Immune System Diseases

Tipo de datos

boolean

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

Elevated white blood cell count | Elevated erythrocyte sedimentation rate

Tipo de datos

boolean

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

Pregnancy

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Long-term oxygen therapy chronic

Tipo de datos

boolean

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

Splenectomy

Tipo de datos

boolean

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

HIV Seropositivity

Tipo de datos

boolean

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

Bleeding uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3842135
Volver a la parte superior de la página

Similar models

Eligibility Non-small Cell Lung Cancer NCT02319408

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial