ID

38168

Descrição

A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay; ODM derived from: https://clinicaltrials.gov/show/NCT01899079

Link

https://clinicaltrials.gov/show/NCT01899079

Palavras-chave

Versões (1)
  1. 24/09/2019 24/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

24 de setembro de 2019

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 NCT01899079

Inglês

Eligibility Breast Cancer NCT01899079

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
resected node-negative, estrogen-receptor-positive, her2-negative early- stage invasive breast cancer (t1-t2, n0, pn0 (i+), pn0 (mol+), m0)
Descrição

Invasive carcinoma of breast Early stage TNM Breast tumor staging | Invasive carcinoma of breast Resected Negative Lymph Node | Invasive carcinoma of breast Estrogen receptor positive HER2 Negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C2363430
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1521996
UMLS CUI [2,3]
C0678034
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0279754
UMLS CUI [3,3]
C2348908
1. estrogen receptor status will be evaluated by immunohistochemistry (ihc)and more than 1% of stained tumor cells will be considered positive.
Descrição

Estrogen Receptor Status Immunohistochemistry

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516974
UMLS CUI [1,2]
C0021044
2. her2 status will be evaluated by (ihc; 0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
Descrição

HER2 Status Immunohistochemistry | HER2 Status Fluorescent in Situ Hybridization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1512413
UMLS CUI [2,2]
C0162789
postmenopausal females, which is defined as:
Descrição

Postmenopausal state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
1. natural amenorrhea > 12 months, regardless of age
Descrição

Amenorrhea Natural Duration | Independent of Age

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0205296
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0001779
2. bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
Descrição

Bilateral oophorectomy | Independent of Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0278321
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0001779
3. radiological castration with amenorrhea > 3 months, regardless of age
Descrição

Castration Radiologic | Amenorrhea Duration | Independent of Age

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007344
UMLS CUI [1,2]
C0205483
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C0001779
4. hysterectomy and postmenopausal blood levels
Descrição

Hysterectomy | Blood Level Postmenopausal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020699
UMLS CUI [2,1]
C0005767
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C0232970
able to give consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
eligible for treatment of breast cancer with adjuvant chemotherapy
Descrição

Eligibility Adjuvant Chemotherapy Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0085533
UMLS CUI [1,3]
C0678222
ecog performance status of 0 or 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
tumor size t3-t4
Descrição

Tumor size TNM Breast tumor staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0474926
non-invasive breast cancer (e.g., paget's disease, dcis)
Descrição

Breast Carcinoma Non-invasive | Paget Disease | DCIS

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205303
UMLS CUI [2]
C1368019
UMLS CUI [3]
C0007124
tumors with nodes that are not n0, pn0 (i+), or pn0 (mol+)
Descrição

Cancer of lymph node TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0948627
UMLS CUI [1,2]
C3258246
tumors that are estrogen-receptor negative or her2 positive
Descrição

Neoplasms Estrogen receptor negative | Neoplasms HER2 positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279756
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C2348909
have metastatic disease
Descrição

Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027627
unable to give informed consent
Descrição

Informed Consent Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
unable to complete patient reported outcome surveys
Descrição

Outcome Surveys Completion Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0038951
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
have contraindications for adjuvant chemotherapy
Descrição

Medical contraindication Adjuvant Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0085533
age, performance status, significant comorbidities
Descrição

Age | Performance status | Comorbidity Significant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1518965
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0750502
ecog performance status > 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Voltar ao início da página

Similar models

Eligibility Breast Cancer NCT01899079

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Early stage TNM Breast tumor staging | Invasive carcinoma of breast Resected Negative Lymph Node | Invasive carcinoma of breast Estrogen receptor positive HER2 Negative
Item
resected node-negative, estrogen-receptor-positive, her2-negative early- stage invasive breast cancer (t1-t2, n0, pn0 (i+), pn0 (mol+), m0)
boolean
C0853879 (UMLS CUI [1,1])
C2363430 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C1521996 (UMLS CUI [2,2])
C0678034 (UMLS CUI [2,3])
C0853879 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C2348908 (UMLS CUI [3,3])
Estrogen Receptor Status Immunohistochemistry
Item
1. estrogen receptor status will be evaluated by immunohistochemistry (ihc)and more than 1% of stained tumor cells will be considered positive.
boolean
C1516974 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
HER2 Status Immunohistochemistry | HER2 Status Fluorescent in Situ Hybridization
Item
2. her2 status will be evaluated by (ihc; 0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
boolean
C1512413 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512413 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Postmenopausal state
Item
postmenopausal females, which is defined as:
boolean
C0232970 (UMLS CUI [1])
Amenorrhea Natural Duration | Independent of Age
Item
1. natural amenorrhea > 12 months, regardless of age
boolean
C0002453 (UMLS CUI [1,1])
C0205296 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0332291 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
Bilateral oophorectomy | Independent of Age
Item
2. bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
boolean
C0278321 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
Castration Radiologic | Amenorrhea Duration | Independent of Age
Item
3. radiological castration with amenorrhea > 3 months, regardless of age
boolean
C0007344 (UMLS CUI [1,1])
C0205483 (UMLS CUI [1,2])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
Hysterectomy | Blood Level Postmenopausal
Item
4. hysterectomy and postmenopausal blood levels
boolean
C0020699 (UMLS CUI [1])
C0005767 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0232970 (UMLS CUI [2,3])
Informed Consent
Item
able to give consent
boolean
C0021430 (UMLS CUI [1])
Eligibility Adjuvant Chemotherapy Breast Carcinoma
Item
eligible for treatment of breast cancer with adjuvant chemotherapy
boolean
C1548635 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor size TNM Breast tumor staging
Item
tumor size t3-t4
boolean
C0475440 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Breast Carcinoma Non-invasive | Paget Disease | DCIS
Item
non-invasive breast cancer (e.g., paget's disease, dcis)
boolean
C0678222 (UMLS CUI [1,1])
C0205303 (UMLS CUI [1,2])
C1368019 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
Cancer of lymph node TNM clinical staging
Item
tumors with nodes that are not n0, pn0 (i+), or pn0 (mol+)
boolean
C0948627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Neoplasms Estrogen receptor negative | Neoplasms HER2 positive
Item
tumors that are estrogen-receptor negative or her2 positive
boolean
C0027651 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
Neoplasm Metastasis
Item
have metastatic disease
boolean
C0027627 (UMLS CUI [1])
Informed Consent Unable
Item
unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Outcome Surveys Completion Unable
Item
unable to complete patient reported outcome surveys
boolean
C1274040 (UMLS CUI [1,1])
C0038951 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Medical contraindication Adjuvant Chemotherapy
Item
have contraindications for adjuvant chemotherapy
boolean
C1301624 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
Age | Performance status | Comorbidity Significant
Item
age, performance status, significant comorbidities
boolean
C0001779 (UMLS CUI [1])
C1518965 (UMLS CUI [2])
C0009488 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status > 1
boolean
C1520224 (UMLS CUI [1])
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