ID

19570

Description

Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00286819

Link

https://clinicaltrials.gov/show/NCT00286819

Keywords

  1. 1/11/17 1/11/17 -
Uploaded on

January 11, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT00286819

Eligibility Breast Cancer NCT00286819

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histological diagnosis of invasive breast cancer
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
patients with early stage i, ii,iii breast cancer amendable for complete surgical resection.
Description

Early-Stage Breast Carcinoma Resectable TNM clinical staging | Complete excision Possible

Data type

boolean

Alias
UMLS CUI [1,1]
C2986665
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0015250
UMLS CUI [2,2]
C0332149
patients with any nodal status
Description

Nodal status Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0449927
UMLS CUI [1,2]
C1552551
patients with er and pr -negative tumors. in case of axillary involvement:any hormonal receptors status.
Description

Estrogen receptor negative neoplasm | Progesterone receptor negative neoplasm | Axillary Lymph Node Involvement Hormone Receptor Any

Data type

boolean

Alias
UMLS CUI [1]
C2584629
UMLS CUI [2]
C2584628
UMLS CUI [3,1]
C0741343
UMLS CUI [3,2]
C0019929
UMLS CUI [3,3]
C1552551
perfomance status 0-1 on the ecog scale
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients indicated for adjuvant chemotherapy
Description

Indication Adjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0085533
no previous chemotherapy or radiotherapy
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
patients have to be randomized within 8 weeks after surgery. its recommended that patients will start chemotherapy within 1 month after surgical treatment.
Description

Operative Surgical Procedure | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0392920
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
pregnancy/breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serious concomitant systemic disorders incompatible with the study
Description

Systemic disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
second primary malignancy (expect in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Description

Neoplasms, Second Primary | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated

Data type

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2]
C0851140
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
use of any other investigational agent within 4 weeks before enrollment into the study
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy
Description

Therapeutic radiology procedure | Chemotherapy | Hormone Therapy | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083

Similar models

Eligibility Breast Cancer NCT00286819

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
patients with histological diagnosis of invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Early-Stage Breast Carcinoma Resectable TNM clinical staging | Complete excision Possible
Item
patients with early stage i, ii,iii breast cancer amendable for complete surgical resection.
boolean
C2986665 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0015250 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
Nodal status Any
Item
patients with any nodal status
boolean
C0449927 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Estrogen receptor negative neoplasm | Progesterone receptor negative neoplasm | Axillary Lymph Node Involvement Hormone Receptor Any
Item
patients with er and pr -negative tumors. in case of axillary involvement:any hormonal receptors status.
boolean
C2584629 (UMLS CUI [1])
C2584628 (UMLS CUI [2])
C0741343 (UMLS CUI [3,1])
C0019929 (UMLS CUI [3,2])
C1552551 (UMLS CUI [3,3])
ECOG performance status
Item
perfomance status 0-1 on the ecog scale
boolean
C1520224 (UMLS CUI [1])
Indication Adjuvant Chemotherapy
Item
patients indicated for adjuvant chemotherapy
boolean
C3146298 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
Chemotherapy | Therapeutic radiology procedure
Item
no previous chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Operative Surgical Procedure | Chemotherapy
Item
patients have to be randomized within 8 weeks after surgery. its recommended that patients will start chemotherapy within 1 month after surgical treatment.
boolean
C0543467 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy/breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease Serious
Item
serious concomitant systemic disorders incompatible with the study
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Neoplasms, Second Primary | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated
Item
second primary malignancy (expect in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
boolean
C0085183 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Investigational New Drugs
Item
use of any other investigational agent within 4 weeks before enrollment into the study
boolean
C0013230 (UMLS CUI [1])
Therapeutic radiology procedure | Chemotherapy | Hormone Therapy | Immunotherapy
Item
cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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