ID

26871

Description

Dendritic Cell Based Therapy for Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00935558

Link

https://clinicaltrials.gov/show/NCT00935558

Keywords

Versions (1)
  1. 10/26/17 10/26/17 -
Copyright Holder

See clnicaltrials.gov

Uploaded on

October 26, 2017

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 Cancer NCT00935558

English

Eligibility Breast Cancer NCT00935558

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histological proven metastatic or locally advanced er+/pgr+ breast cancer in progression after receiving 1. line endocrine therapy.
Description

Secondary malignant neoplasm of female breast Estrogen receptor positive Progressive | Secondary malignant neoplasm of female breast Progesterone receptor positive Progressive | Locally advanced breast cancer Estrogen receptor positive Progressive | Locally advanced breast cancer Progesterone receptor positive Progressive | Hormone Therapy First line

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C0205329
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0279759
UMLS CUI [2,3]
C0205329
UMLS CUI [3,1]
C3495949
UMLS CUI [3,2]
C0279754
UMLS CUI [3,3]
C0205329
UMLS CUI [4,1]
C3495949
UMLS CUI [4,2]
C0279759
UMLS CUI [4,3]
C0205329
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C1708063
further inclusion criteria: p53+ tumour, ps≤1, postmenopausal. age >18, ps ≤ 1 and acceptable cbc and blood chemistry results
Description

Neoplasm Protein p53 Positive | performance status | Postmenopausal state | Age | Full blood count normal | Blood chemistry normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0080055
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C1518965
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0427692
UMLS CUI [6]
C0438257
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of the skin)
Description

Neoplastic disease | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
patients with metastatic disease in the central nervous system
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
patients with other significant illness including severe allergy, asthma, dm, angina pectoris or congestive heart failure
Description

Illness | Severe allergy | Asthma | Diabetes Mellitus | Angina Pectoris | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C2945656
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0002962
UMLS CUI [6]
C0018802
patients with acute or chronic infection including hiv, hepatitis og tb
Description

Communicable Disease | Chronic infectious disease | HIV Infection | Hepatitis | Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0019158
UMLS CUI [5]
C0041296
patients who received antineoplastic therapy including chemotherapy, radiation, immunotherapy or other agents, less than 4 weeks before the beginning of the trial
Description

Antineoplastic Drug/Agent Therapy | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C2346834
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0013227
patients who received corticosteroids or other immunosuppressive agents
Description

Adrenal Cortex Hormones | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0021081
patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis
Description

Autoimmune Diseases | Lupus Erythematosus | Rheumatoid Arthritis | Thyroiditis

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0040147
severe hypercalcemia
Description

Hypercalcemia Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0205082
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT00935558

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast Estrogen receptor positive Progressive | Secondary malignant neoplasm of female breast Progesterone receptor positive Progressive | Locally advanced breast cancer Estrogen receptor positive Progressive | Locally advanced breast cancer Progesterone receptor positive Progressive | Hormone Therapy First line
Item
patients with histological proven metastatic or locally advanced er+/pgr+ breast cancer in progression after receiving 1. line endocrine therapy.
boolean
C0346993 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
C0346993 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0205329 (UMLS CUI [2,3])
C3495949 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C0205329 (UMLS CUI [3,3])
C3495949 (UMLS CUI [4,1])
C0279759 (UMLS CUI [4,2])
C0205329 (UMLS CUI [4,3])
C0279025 (UMLS CUI [5,1])
C1708063 (UMLS CUI [5,2])
Neoplasm Protein p53 Positive | performance status | Postmenopausal state | Age | Full blood count normal | Blood chemistry normal
Item
further inclusion criteria: p53+ tumour, ps≤1, postmenopausal. age >18, ps ≤ 1 and acceptable cbc and blood chemistry results
boolean
C0027651 (UMLS CUI [1,1])
C0080055 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C1518965 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0427692 (UMLS CUI [5])
C0438257 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Neoplastic disease | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of the skin)
boolean
C1882062 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
CNS metastases
Item
patients with metastatic disease in the central nervous system
boolean
C0686377 (UMLS CUI [1])
Illness | Severe allergy | Asthma | Diabetes Mellitus | Angina Pectoris | Congestive heart failure
Item
patients with other significant illness including severe allergy, asthma, dm, angina pectoris or congestive heart failure
boolean
C0221423 (UMLS CUI [1])
C2945656 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0002962 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
Communicable Disease | Chronic infectious disease | HIV Infection | Hepatitis | Tuberculosis
Item
patients with acute or chronic infection including hiv, hepatitis og tb
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
C0041296 (UMLS CUI [5])
Antineoplastic Drug/Agent Therapy | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Pharmaceutical Preparations
Item
patients who received antineoplastic therapy including chemotherapy, radiation, immunotherapy or other agents, less than 4 weeks before the beginning of the trial
boolean
C2346834 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0013227 (UMLS CUI [5])
Adrenal Cortex Hormones | Immunosuppressive Agents
Item
patients who received corticosteroids or other immunosuppressive agents
boolean
C0001617 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
Autoimmune Diseases | Lupus Erythematosus | Rheumatoid Arthritis | Thyroiditis
Item
patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis
boolean
C0004364 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0040147 (UMLS CUI [4])
Hypercalcemia Severe
Item
severe hypercalcemia
boolean
C0020437 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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