ID

26871

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00935558

Stichworte

Versionen (1)
  1. 26.10.17 26.10.17 -
Rechteinhaber

See clnicaltrials.gov

Hochgeladen am

26. Oktober 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Breast Cancer NCT00935558

Englisch

Eligibility Breast Cancer NCT00935558

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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)
Beschreibung

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

Datentyp

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
Beschreibung

CNS metastases

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Adrenal Cortex Hormones | Immunosuppressive Agents

Datentyp

boolean

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

Autoimmune Diseases | Lupus Erythematosus | Rheumatoid Arthritis | Thyroiditis

Datentyp

boolean

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

Hypercalcemia Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0205082
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Ähnliche Modelle

Eligibility Breast Cancer NCT00935558

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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