ID

12927

Description

German Preoperative Adriamycin Docetaxel Study; ODM derived from: https://clinicaltrials.gov/show/NCT00543829

Link

https://clinicaltrials.gov/show/NCT00543829

Keywords

Versions (1)
  1. 1/6/16 1/6/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 6, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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.

Back to model comments
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 Neoplasms NCT00543829

English

Eligibility Breast Neoplasms NCT00543829

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
unilateral primary carcinoma of the breast, confirmed histologically by core-cut needle or incisional biopsy. fine needle aspiration is not sufficient.
Description

unilateral primary carcinoma of the breast, confirmed histologically by core-cut needle or incisional biopsy. fine needle aspiration is not sufficient

Data type

boolean

Alias
UMLS CUI [1]
C0678222
bidimensionally measurable tumour, either by mammography or breast ultrasound or breast mri
Description

bidimensionally measurable tumour, either by mammography or breast ultrasound or breast mri

Data type

boolean

Alias
UMLS CUI [1]
C1302351
primary tumour >= 3 cm in largest diameter. in patients with multifocal or multicentric breast cancer the largest lesion should be measured.
Description

primary tumour >= 3 cm in largest diameter. in patients with multifocal or multicentric breast cancer the largest lesion should be measured.

Data type

boolean

Alias
UMLS CUI [1]
C1302351
no evidence of distant metastases (as confirmed by chest x-ray, liver ultrasound and bone scintigraphy)
Description

distant metastases

Data type

boolean

Alias
UMLS CUI [1]
C1302548
age >= 18 years and <= 70 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy at least 10 years, ignoring the diagnosis of cancer.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
karnofsky index >=70%.
Description

karnofsky index

Data type

boolean

Alias
UMLS CUI [1]
C0206065
adequate haematologic, renal and hepatic function (wbc >4000, platelets >100000, bilirubin, serum creatinine and transaminases within the normal range).
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
anamnestic and electrocardiographic evidence of normal cardiac function, without or with medication. normal cardiac function measured by echocardiography or muga-scan.
Description

cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
negative pregnancy test and appropriate non-hormonal contraception in fertile women.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
written informed consent and presumed compliance of the patients.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
locally advanced (stage t4), bilateral, metastatic, or inflammatory breast cancer (tethering or dimpling of the skin as well as nipple inversion may not easily be interpreted as skin infiltration). if one of these conditions is suspected it has to be excluded before enrollment onto study.
Description

locally advanced (stage t4), bilateral, metastatic, or inflammatory breast cancer (tethering or dimpling of the skin as well as nipple inversion may not easily be interpreted as skin infiltration). if one of these conditions is suspected it has to be excluded before enrollment onto study.

Data type

boolean

Alias
UMLS CUI [1]
C1300072
UMLS CUI [2]
C0278601
previous treatment for breast cancer, including surgery, radiation, cytotoxic or endocrine treatments. surgical diagnostic procedures are allowed.
Description

previous treatment

Data type

boolean

Alias
UMLS CUI [1]
C0087111
previous malignancy other than breast cancer or non-invasive breast lesions if the disease-free interval is less than 10 years.
Description

previous malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
previous cytotoxic treatment for any condition.
Description

cytotoxic treatment

Data type

boolean

Alias
UMLS CUI [1]
C0304497
preexisting neurotoxicity greater than grade ii (who).
Description

neurotoxicity

Data type

boolean

Alias
UMLS CUI [1]
C0235032
active infection or other significant illness that could influence tolerability of treatment.
Description

active infection or other significant illness that could influence tolerability of treatment.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348563
current treatment with sex hormones (treatment has to be discontinued before the start of systemic therapy).
Description

treatment with sex hormones

Data type

boolean

Alias
UMLS CUI [1]
C0279025
psychiatric illness or drug addiction that would preclude obtaining informed consent.
Description

psychiatric illness or drug addiction that would preclude obtaining informed consent.

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
Back to the top of the page

Similar models

Eligibility Breast Neoplasms NCT00543829

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
unilateral primary carcinoma of the breast, confirmed histologically by core-cut needle or incisional biopsy. fine needle aspiration is not sufficient
Item
unilateral primary carcinoma of the breast, confirmed histologically by core-cut needle or incisional biopsy. fine needle aspiration is not sufficient.
boolean
C0678222 (UMLS CUI [1])
bidimensionally measurable tumour, either by mammography or breast ultrasound or breast mri
Item
bidimensionally measurable tumour, either by mammography or breast ultrasound or breast mri
boolean
C1302351 (UMLS CUI [1])
primary tumour >= 3 cm in largest diameter. in patients with multifocal or multicentric breast cancer the largest lesion should be measured.
Item
primary tumour >= 3 cm in largest diameter. in patients with multifocal or multicentric breast cancer the largest lesion should be measured.
boolean
C1302351 (UMLS CUI [1])
distant metastases
Item
no evidence of distant metastases (as confirmed by chest x-ray, liver ultrasound and bone scintigraphy)
boolean
C1302548 (UMLS CUI [1])
age
Item
age >= 18 years and <= 70 years.
boolean
C0001779 (UMLS CUI [1])
life expectancy
Item
life expectancy at least 10 years, ignoring the diagnosis of cancer.
boolean
C0023671 (UMLS CUI [1])
karnofsky index
Item
karnofsky index >=70%.
boolean
C0206065 (UMLS CUI [1])
organ function
Item
adequate haematologic, renal and hepatic function (wbc >4000, platelets >100000, bilirubin, serum creatinine and transaminases within the normal range).
boolean
C0678852 (UMLS CUI [1])
cardiac function
Item
anamnestic and electrocardiographic evidence of normal cardiac function, without or with medication. normal cardiac function measured by echocardiography or muga-scan.
boolean
C0232164 (UMLS CUI [1])
pregnancy
Item
negative pregnancy test and appropriate non-hormonal contraception in fertile women.
boolean
C0032961 (UMLS CUI [1])
informed consent
Item
written informed consent and presumed compliance of the patients.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
locally advanced (stage t4), bilateral, metastatic, or inflammatory breast cancer (tethering or dimpling of the skin as well as nipple inversion may not easily be interpreted as skin infiltration). if one of these conditions is suspected it has to be excluded before enrollment onto study.
Item
locally advanced (stage t4), bilateral, metastatic, or inflammatory breast cancer (tethering or dimpling of the skin as well as nipple inversion may not easily be interpreted as skin infiltration). if one of these conditions is suspected it has to be excluded before enrollment onto study.
boolean
C1300072 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
previous treatment
Item
previous treatment for breast cancer, including surgery, radiation, cytotoxic or endocrine treatments. surgical diagnostic procedures are allowed.
boolean
C0087111 (UMLS CUI [1])
previous malignancy
Item
previous malignancy other than breast cancer or non-invasive breast lesions if the disease-free interval is less than 10 years.
boolean
C0006826 (UMLS CUI [1])
cytotoxic treatment
Item
previous cytotoxic treatment for any condition.
boolean
C0304497 (UMLS CUI [1])
neurotoxicity
Item
preexisting neurotoxicity greater than grade ii (who).
boolean
C0235032 (UMLS CUI [1])
active infection or other significant illness that could influence tolerability of treatment.
Item
active infection or other significant illness that could influence tolerability of treatment.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
treatment with sex hormones
Item
current treatment with sex hormones (treatment has to be discontinued before the start of systemic therapy).
boolean
C0279025 (UMLS CUI [1])
psychiatric illness or drug addiction that would preclude obtaining informed consent.
Item
psychiatric illness or drug addiction that would preclude obtaining informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Back to the top of the page 

Contact

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

Fields marked with * are required.

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