ID

26630

Descrição

Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.; ODM derived from: https://clinicaltrials.gov/show/NCT00744653

Link

https://clinicaltrials.gov/show/NCT00744653

Palavras-chave

Versões (2)
  1. 19/10/2017 19/10/2017 -
  2. 22/10/2017 22/10/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de outubro de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Breast Cancer NCT00744653

Inglês

Eligibility Breast Cancer NCT00744653

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
histological proven cancer of the breast.
Descrição

Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678222
progressive and/or metastatic disease.
Descrição

Progressive Disease | Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C0027627
no further standard treatment for the patient available or the patient does not wish to receive the offered standard treatment.
Descrição

Standard therapy Unavailable | Standard therapy Patient Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0686905
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0558080
if endocrine therapy: progression in cutaneous lesions.
Descrição

Hormone Therapy | Skin lesion Progression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0037284
UMLS CUI [2,2]
C0242656
if treatment with trastuzumab (herceptin)can continue this treatment if there is no regression in cutaneous lesions.
Descrição

trastuzumab | Herceptin | Skin lesion Regression Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2]
C0338204
UMLS CUI [3,1]
C0037284
UMLS CUI [3,2]
C0684320
UMLS CUI [3,3]
C0332197
at least 2 weeks since last chemotherapy, patients treated with navelbine (vinorelbine), capecitabin (xeloda) or weekly paclitaxel (taxol)can continue this treatment if there is no regression in cutaneous metastases.
Descrição

Chemotherapy | Navelbine | vinorelbine | capecitabine | Xeloda | Paclitaxel | Taxol | Secondary malignant neoplasm of skin Regression Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0131965
UMLS CUI [3]
C0078257
UMLS CUI [4]
C0671970
UMLS CUI [5]
C0724419
UMLS CUI [6]
C0144576
UMLS CUI [7]
C0678133
UMLS CUI [8,1]
C0153687
UMLS CUI [8,2]
C0684320
UMLS CUI [8,3]
C0332197
malignant cutaneous or subcutaneous lesion to be treated ≥ 3 cm.
Descrição

Skin lesion Malignant Size | Lesion subcutaneous Malignant Size

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0205282
UMLS CUI [1,3]
C0456389
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0443315
UMLS CUI [2,3]
C0205282
UMLS CUI [2,4]
C0456389
who performance ≤ 2.
Descrição

WHO performance status scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy of at least 3 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
platelets ≥ 50 mia/l, pp ≥ 40, aptt in normal area. medical correction is allowed.
Descrição

Platelet Count measurement | APTT measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0030605
sexual active men and women must use safe anticonceptive during and up to 6 month after last treatment.
Descrição

Study Subject Sexually active Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
written informed consent must be obtained according to the local ethics committee requirements.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute lung infection
Descrição

Infectious disease of lung

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0876973
previous bleomycin treatment exceeding 200.000 units/m2.
Descrição

Bleomycin Dosage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005740
UMLS CUI [1,2]
C0178602
known hypersensitivity to any of the components of the treatment.
Descrição

Hypersensitivity Component Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0087111
known hypersensitivity to any of the components used in the planned anesthesia.
Descrição

Hypersensitivity Component Anesthesia Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0002903
UMLS CUI [1,4]
C1301732
pregnant or lactating women. in fertile women this is ensured by measuring hcg in blood.
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Blood human chorionic gonadotropin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0853985
treatment with granulocyte colony stimulating factor (g-csf) or other cytokines.
Descrição

Granulocyte Colony-Stimulating Factor | cytokine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0079189
Voltar ao início da página

Similar models

Eligibility Breast Cancer NCT00744653

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma
Item
histological proven cancer of the breast.
boolean
C0678222 (UMLS CUI [1])
Progressive Disease | Neoplasm Metastasis
Item
progressive and/or metastatic disease.
boolean
C1335499 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Standard therapy Unavailable | Standard therapy Patient Unwilling
Item
no further standard treatment for the patient available or the patient does not wish to receive the offered standard treatment.
boolean
C2936643 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Hormone Therapy | Skin lesion Progression
Item
if endocrine therapy: progression in cutaneous lesions.
boolean
C0279025 (UMLS CUI [1])
C0037284 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
trastuzumab | Herceptin | Skin lesion Regression Absent
Item
if treatment with trastuzumab (herceptin)can continue this treatment if there is no regression in cutaneous lesions.
boolean
C0728747 (UMLS CUI [1])
C0338204 (UMLS CUI [2])
C0037284 (UMLS CUI [3,1])
C0684320 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Chemotherapy | Navelbine | vinorelbine | capecitabine | Xeloda | Paclitaxel | Taxol | Secondary malignant neoplasm of skin Regression Absent
Item
at least 2 weeks since last chemotherapy, patients treated with navelbine (vinorelbine), capecitabin (xeloda) or weekly paclitaxel (taxol)can continue this treatment if there is no regression in cutaneous metastases.
boolean
C0392920 (UMLS CUI [1])
C0131965 (UMLS CUI [2])
C0078257 (UMLS CUI [3])
C0671970 (UMLS CUI [4])
C0724419 (UMLS CUI [5])
C0144576 (UMLS CUI [6])
C0678133 (UMLS CUI [7])
C0153687 (UMLS CUI [8,1])
C0684320 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
Skin lesion Malignant Size | Lesion subcutaneous Malignant Size
Item
malignant cutaneous or subcutaneous lesion to be treated ≥ 3 cm.
boolean
C0037284 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0443315 (UMLS CUI [2,2])
C0205282 (UMLS CUI [2,3])
C0456389 (UMLS CUI [2,4])
WHO performance status scale
Item
who performance ≤ 2.
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months.
boolean
C0023671 (UMLS CUI [1])
Platelet Count measurement | APTT measurement
Item
platelets ≥ 50 mia/l, pp ≥ 40, aptt in normal area. medical correction is allowed.
boolean
C0032181 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
Study Subject Sexually active Contraceptive methods
Item
sexual active men and women must use safe anticonceptive during and up to 6 month after last treatment.
boolean
C0681850 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent must be obtained according to the local ethics committee requirements.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Infectious disease of lung
Item
acute lung infection
boolean
C0876973 (UMLS CUI [1])
Bleomycin Dosage
Item
previous bleomycin treatment exceeding 200.000 units/m2.
boolean
C0005740 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Hypersensitivity Component Therapeutic procedure
Item
known hypersensitivity to any of the components of the treatment.
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Hypersensitivity Component Anesthesia Planned
Item
known hypersensitivity to any of the components used in the planned anesthesia.
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0002903 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Pregnancy | Breast Feeding | Childbearing Potential Blood human chorionic gonadotropin
Item
pregnant or lactating women. in fertile women this is ensured by measuring hcg in blood.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0853985 (UMLS CUI [3,2])
Granulocyte Colony-Stimulating Factor | cytokine
Item
treatment with granulocyte colony stimulating factor (g-csf) or other cytokines.
boolean
C0079459 (UMLS CUI [1])
C0079189 (UMLS CUI [2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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