ID

26600

Descrição

Cytokine Expression During Radiation for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00836186

Link

https://clinicaltrials.gov/show/NCT00836186

Palavras-chave

Versões (1)
  1. 21/10/2017 21/10/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

21 de outubro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00836186

Inglês

Eligibility Breast Cancer NCT00836186

1 Formulários  
Criteria
Descrição

Criteria

patients must have histologically confirmed (by routine h&e staining) adenocarcinoma of the breast any t or n no m disease patients with squamous carcinomas or sarcomas of the breast cancer are not eligible
Descrição

Breast adenocarcinoma TNM Breast tumor staging Hematoxylin and eosin stain method | Squamous cell carcinoma of breast Ineligible | Sarcoma of breast Ineligible

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0474926
UMLS CUI [1,3]
C0523207
UMLS CUI [2,1]
C1336079
UMLS CUI [2,2]
C1512714
UMLS CUI [3,1]
C0349667
UMLS CUI [3,2]
C1512714
patients must have undergone a segmental mastectomy sm with a level i and ll axillary dissection or sentinel lymph node biopsy surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved. patients treated with a mastectomy are not eligible
Descrição

Segmental Mastectomy | Excision of axillary lymph nodes Level | Sentinel Lymph Node Biopsy | Operative Surgical Procedure Local | Negative Surgical Margin Invasive carcinoma of breast | Negative Surgical Margin Noninfiltrating Intraductal Carcinoma | Mastectomy Ineligible

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024885
UMLS CUI [2,1]
C0193867
UMLS CUI [2,2]
C0441889
UMLS CUI [3]
C0796693
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0205276
UMLS CUI [5,1]
C1709157
UMLS CUI [5,2]
C0853879
UMLS CUI [6,1]
C1709157
UMLS CUI [6,2]
C0007124
UMLS CUI [7,1]
C0024881
UMLS CUI [7,2]
C1512714
patients must be registered such that radiation therapy begins within 10 weeks of last surgery
Descrição

Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
patients must have a performance status 0 or 1 by ecog criteria or a 80-100 karnofsky performance scale at time of consult
Descrição

ECOG performance status | Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
patients must not have received prior radiation therapy to the breast at any time for any reason
Descrição

Irradiation of breast Previous Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2148528
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2828389
any patient with active local-regional disease prior to registration is not eligible
Descrição

Disease Local-Regional Ineligible

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1947913
UMLS CUI [1,3]
C1512714
no other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years
Descrição

Cancer Other Excluded | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Disease Free of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy
Descrição

Pregnancy Excluded | Childbearing Potential Contraceptive methods | Exception Hormonal contraception | Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2985296
UMLS CUI [4]
C1522449
patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment
Descrição

Exclusion Criteria | Illness Serious Preventing Informed Consent | Mental disorders Serious Preventing Informed Consent | Illness Serious Preventing Treatment Compliance | Mental disorders Serious Preventing Treatment Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C1292733
UMLS CUI [3,4]
C0021430
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C1292733
UMLS CUI [4,4]
C1321605
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C1292733
UMLS CUI [5,4]
C1321605
all patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
women of all races and ethnic groups are eligible for this trial
Descrição

Gender | Racial group All | Ethnic group All

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C0444868
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C0444868
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Similar models

Eligibility Breast Cancer NCT00836186

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Breast adenocarcinoma TNM Breast tumor staging Hematoxylin and eosin stain method | Squamous cell carcinoma of breast Ineligible | Sarcoma of breast Ineligible
Item
patients must have histologically confirmed (by routine h&e staining) adenocarcinoma of the breast any t or n no m disease patients with squamous carcinomas or sarcomas of the breast cancer are not eligible
boolean
C0858252 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0523207 (UMLS CUI [1,3])
C1336079 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
C0349667 (UMLS CUI [3,1])
C1512714 (UMLS CUI [3,2])
Segmental Mastectomy | Excision of axillary lymph nodes Level | Sentinel Lymph Node Biopsy | Operative Surgical Procedure Local | Negative Surgical Margin Invasive carcinoma of breast | Negative Surgical Margin Noninfiltrating Intraductal Carcinoma | Mastectomy Ineligible
Item
patients must have undergone a segmental mastectomy sm with a level i and ll axillary dissection or sentinel lymph node biopsy surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved. patients treated with a mastectomy are not eligible
boolean
C0024885 (UMLS CUI [1])
C0193867 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0796693 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
C1709157 (UMLS CUI [5,1])
C0853879 (UMLS CUI [5,2])
C1709157 (UMLS CUI [6,1])
C0007124 (UMLS CUI [6,2])
C0024881 (UMLS CUI [7,1])
C1512714 (UMLS CUI [7,2])
Therapeutic radiology procedure
Item
patients must be registered such that radiation therapy begins within 10 weeks of last surgery
boolean
C1522449 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
patients must have a performance status 0 or 1 by ecog criteria or a 80-100 karnofsky performance scale at time of consult
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Irradiation of breast Previous Excluded
Item
patients must not have received prior radiation therapy to the breast at any time for any reason
boolean
C2148528 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Disease Local-Regional Ineligible
Item
any patient with active local-regional disease prior to registration is not eligible
boolean
C0012634 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
Cancer Other Excluded | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Disease Free of
Item
no other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years
boolean
C1707251 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
Pregnancy Excluded | Childbearing Potential Contraceptive methods | Exception Hormonal contraception | Therapeutic radiology procedure
Item
patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2985296 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4])
Exclusion Criteria | Illness Serious Preventing Informed Consent | Mental disorders Serious Preventing Informed Consent | Illness Serious Preventing Treatment Compliance | Mental disorders Serious Preventing Treatment Compliance
Item
patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment
boolean
C0680251 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C1292733 (UMLS CUI [3,3])
C0021430 (UMLS CUI [3,4])
C0221423 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C1292733 (UMLS CUI [4,3])
C1321605 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C1292733 (UMLS CUI [5,3])
C1321605 (UMLS CUI [5,4])
Informed Consent
Item
all patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Gender | Racial group All | Ethnic group All
Item
women of all races and ethnic groups are eligible for this trial
boolean
C0079399 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C0444868 (UMLS CUI [3,2])
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