ID

26630

Beschrijving

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

Trefwoorden

Versies (2)
  1. 19-10-17 19-10-17 -
  2. 22-10-17 22-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 oktober 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00744653

Engels

Eligibility Breast Cancer NCT00744653

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18
Beschrijving

Age

Datatype

boolean

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

Breast Carcinoma

Datatype

boolean

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

Progressive Disease | Neoplasm Metastasis

Datatype

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.
Beschrijving

Standard therapy Unavailable | Standard therapy Patient Unwilling

Datatype

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.
Beschrijving

Hormone Therapy | Skin lesion Progression

Datatype

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.
Beschrijving

trastuzumab | Herceptin | Skin lesion Regression Absent

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Skin lesion Malignant Size | Lesion subcutaneous Malignant Size

Datatype

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.
Beschrijving

WHO performance status scale

Datatype

boolean

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

Life Expectancy

Datatype

boolean

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

Platelet Count measurement | APTT measurement

Datatype

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.
Beschrijving

Study Subject Sexually active Contraceptive methods

Datatype

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.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute lung infection
Beschrijving

Infectious disease of lung

Datatype

boolean

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

Bleomycin Dosage

Datatype

boolean

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

Hypersensitivity Component Therapeutic procedure

Datatype

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.
Beschrijving

Hypersensitivity Component Anesthesia Planned

Datatype

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.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Blood human chorionic gonadotropin

Datatype

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.
Beschrijving

Granulocyte Colony-Stimulating Factor | cytokine

Datatype

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0079189
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00744653

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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