ID

37944

Description

Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01305954

Link

https://clinicaltrials.gov/show/NCT01305954

Keywords

Versions (1)
  1. 9/2/19 9/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 2, 2019

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.

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 Cancer NCT01305954

English

Eligibility Breast Cancer NCT01305954

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 18 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed stage i-iv breast cancer;
Description

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
ecog performance status 0-3;
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
Description

Chemotherapy cycle Neoadjuvant Scheduled | Chemotherapy cycle Adjuvant Scheduled | Chemotherapy cycle Scheduled Neoplasm Metastasis | Disease Newly Diagnosed | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C0205539
UMLS CUI [3,3]
C0027627
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1518321
UMLS CUI [5]
C0277556
growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
Description

Growth Factors | Filgrastim | pegfilgrastim

Data type

boolean

Alias
UMLS CUI [1]
C0018284
UMLS CUI [2]
C0210630
UMLS CUI [3]
C1136535
absolute lymphocyte count (alc) > 500 cells/μl as determined by routine cbc with differential;
Description

Absolute lymphocyte count | Complete blood count with differential

Data type

boolean

Alias
UMLS CUI [1]
C3544087
UMLS CUI [2]
C0545131
signed, irb approved written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of acute, active infection;
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
Description

Bone Marrow Disease Clonal | MYELODYSPLASTIC SYNDROME | Myeloproliferative disease | Acute leukemia | Chronic leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0005956
UMLS CUI [1,2]
C1522642
UMLS CUI [2]
C3463824
UMLS CUI [3]
C0027022
UMLS CUI [4]
C0085669
UMLS CUI [5]
C1279296
other co-morbid illness which would impair ability to participate in the study;
Description

Comorbidity Impairing Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C2348568
concurrent experimental therapy (note: concurrent biologic therapy is permitted, provided it is not experimental).
Description

Therapy, Investigational | Biological treatment Standard allowed

Data type

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1442989
UMLS CUI [2,3]
C0683607
prior or current receipt of histone deacetylase (hdac) inhibitors
Description

Histone deacetylase inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1512474
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT01305954

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥ 18 years of age;
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
histologically confirmed stage i-iv breast cancer;
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-3;
boolean
C1520224 (UMLS CUI [1])
Chemotherapy cycle Neoadjuvant Scheduled | Chemotherapy cycle Adjuvant Scheduled | Chemotherapy cycle Scheduled Neoplasm Metastasis | Disease Newly Diagnosed | Recurrent disease
Item
scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
boolean
C1302181 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C1302181 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C1302181 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C1518321 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5])
Growth Factors | Filgrastim | pegfilgrastim
Item
growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
boolean
C0018284 (UMLS CUI [1])
C0210630 (UMLS CUI [2])
C1136535 (UMLS CUI [3])
Absolute lymphocyte count | Complete blood count with differential
Item
absolute lymphocyte count (alc) > 500 cells/μl as determined by routine cbc with differential;
boolean
C3544087 (UMLS CUI [1])
C0545131 (UMLS CUI [2])
Informed Consent
Item
signed, irb approved written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
presence of acute, active infection;
boolean
C0009450 (UMLS CUI [1])
Bone Marrow Disease Clonal | MYELODYSPLASTIC SYNDROME | Myeloproliferative disease | Acute leukemia | Chronic leukemia
Item
history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
boolean
C0005956 (UMLS CUI [1,1])
C1522642 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2])
C0027022 (UMLS CUI [3])
C0085669 (UMLS CUI [4])
C1279296 (UMLS CUI [5])
Comorbidity Impairing Study Subject Participation Status
Item
other co-morbid illness which would impair ability to participate in the study;
boolean
C0009488 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Therapy, Investigational | Biological treatment Standard allowed
Item
concurrent experimental therapy (note: concurrent biologic therapy is permitted, provided it is not experimental).
boolean
C0949266 (UMLS CUI [1])
C1531518 (UMLS CUI [2,1])
C1442989 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Histone deacetylase inhibitor
Item
prior or current receipt of histone deacetylase (hdac) inhibitors
boolean
C1512474 (UMLS CUI [1])
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