ID

26630

Description

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

Keywords

Versions (2)
  1. 10/19/17 10/19/17 -
  2. 10/22/17 10/22/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00744653

English

Eligibility Breast Cancer NCT00744653

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18
Description

Age

Data type

boolean

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

Breast Carcinoma

Data type

boolean

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

Progressive Disease | Neoplasm Metastasis

Data type

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.
Description

Standard therapy Unavailable | Standard therapy Patient Unwilling

Data type

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.
Description

Hormone Therapy | Skin lesion Progression

Data type

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.
Description

trastuzumab | Herceptin | Skin lesion Regression Absent

Data type

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.
Description

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

Data type

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.
Description

Skin lesion Malignant Size | Lesion subcutaneous Malignant Size

Data type

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.
Description

WHO performance status scale

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Platelet Count measurement | APTT measurement

Data type

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.
Description

Study Subject Sexually active Contraceptive methods

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute lung infection
Description

Infectious disease of lung

Data type

boolean

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

Bleomycin Dosage

Data type

boolean

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

Hypersensitivity Component Therapeutic procedure

Data type

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.
Description

Hypersensitivity Component Anesthesia Planned

Data type

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.
Description

Pregnancy | Breast Feeding | Childbearing Potential Blood human chorionic gonadotropin

Data type

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.
Description

Granulocyte Colony-Stimulating Factor | cytokine

Data type

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0079189
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Similar models

Eligibility Breast Cancer NCT00744653

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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