ID

13209

Descrição

Tumor-Pulsed Dendritic Cells Used as a Tumor Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00176761

Link

https://clinicaltrials.gov/show/NCT00176761

Palavras-chave

Versões (1)
  1. 24/01/2016 24/01/2016 -
Transferido a

24 de janeiro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00176761

Inglês

Eligibility Metastatic Colorectal Cancer NCT00176761

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have metastatic colorectal cancer. patients are eligible whether they are previously untreated or had received prior treatment.
Descrição

metastatic colorectal cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0027627
2. patients must have a source of autologous tumor that can be easily harvested. this includes patients with subcutaneous or cutaneous metastases, patients with easily excisable lymph nodes containing metastatic tumor, and patients with malignant pleural effusions or ascites. in addition, some patients who undergo a planned curative operation are found at that time of surgery to be unresectable and these patients could have a sample of tumor resected at that time to be eligible for this study.
Descrição

tumor location

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0814423
3. karnofsky performance status equal to or greater than 70%.
Descrição

karnofsky

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
4. life expectancy of at least three months.
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
5. patients must have evaluable or measurable disease in addition to the disease that will be surgically removed for the purposes of formulating the autologous vaccine.
Descrição

measurable or evaluable disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
6.1. platelet count equal to or greater than 100,000/mm3
Descrição

platelet count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
6.2. total white blood count equal to or greater than 3,000/mm3
Descrição

wbc

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
7. patients must not have received any antineoplastic chemotherapy or immunotherapy for the four weeks preceding entry onto the study (six weeks for nitrosoureas and mitomycin-c).
Descrição

chemotherapy, immunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
8. patients must not have received irradiation for the four weeks prior to entry onto the study.
Descrição

irradiation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
9. ability to give informed consent.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients may not have received prior antitumor vaccines.
Descrição

antitumor vaccines

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0376659
2. history of any autoimmune diseases (e.g. sle, rheumatoid arthritis, myasthenia gravis).
Descrição

autoimmune diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
3. active infection (bacterial, fungal, or viral), or active bleeding (e.g. hemoptysis, gi bleeding).
Descrição

infection, bleeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019080
4. pregnancy or lactation; women of childbearing potential and men must use effective contraception during the course of this clinical trial.
Descrição

pregnancy or lactation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. uncontrolled angina, arrhythmias, bronchospasm, hypertension, hyperglycemia or hypercalcemia.
Descrição

comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
6. history of corticosteroid use in the four weeks preceding entry onto the clinical study.
Descrição

corticosteroid

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001617
7. patients who require corticosteroids.
Descrição

corticosteroids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001617
8. evidence of hiv infection or aids and/or testing positive for hbsag.
Descrição

hiv, hbsag

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019168
9. any medical or psychiatric illness which in the opinion of the clinical investigators would compromise the patients ability to tolerate this treatment.
Descrição

comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
10. patients who require anticoagulation.
Descrição

anticoagulants

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003280
11. there is no exclusion for sex or ethnic background.
Descrição

gender, ethnicity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0015031
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00176761

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
metastatic colorectal cancer
Item
1. patients must have metastatic colorectal cancer. patients are eligible whether they are previously untreated or had received prior treatment.
boolean
C0009402 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
tumor location
Item
2. patients must have a source of autologous tumor that can be easily harvested. this includes patients with subcutaneous or cutaneous metastases, patients with easily excisable lymph nodes containing metastatic tumor, and patients with malignant pleural effusions or ascites. in addition, some patients who undergo a planned curative operation are found at that time of surgery to be unresectable and these patients could have a sample of tumor resected at that time to be eligible for this study.
boolean
C0814423 (UMLS CUI [1])
karnofsky
Item
3. karnofsky performance status equal to or greater than 70%.
boolean
C0206065 (UMLS CUI [1])
life expectancy
Item
4. life expectancy of at least three months.
boolean
C0023671 (UMLS CUI [1])
measurable or evaluable disease
Item
5. patients must have evaluable or measurable disease in addition to the disease that will be surgically removed for the purposes of formulating the autologous vaccine.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
platelet count
Item
6.1. platelet count equal to or greater than 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
wbc
Item
6.2. total white blood count equal to or greater than 3,000/mm3
boolean
C0023508 (UMLS CUI [1])
chemotherapy, immunotherapy
Item
7. patients must not have received any antineoplastic chemotherapy or immunotherapy for the four weeks preceding entry onto the study (six weeks for nitrosoureas and mitomycin-c).
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
irradiation
Item
8. patients must not have received irradiation for the four weeks prior to entry onto the study.
boolean
C1522449 (UMLS CUI [1])
informed consent
Item
9. ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
antitumor vaccines
Item
1. patients may not have received prior antitumor vaccines.
boolean
C0376659 (UMLS CUI [1])
autoimmune diseases
Item
2. history of any autoimmune diseases (e.g. sle, rheumatoid arthritis, myasthenia gravis).
boolean
C0004364 (UMLS CUI [1])
infection, bleeding
Item
3. active infection (bacterial, fungal, or viral), or active bleeding (e.g. hemoptysis, gi bleeding).
boolean
C0009450 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
pregnancy or lactation
Item
4. pregnancy or lactation; women of childbearing potential and men must use effective contraception during the course of this clinical trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
comorbidity
Item
5. uncontrolled angina, arrhythmias, bronchospasm, hypertension, hyperglycemia or hypercalcemia.
boolean
C0009488 (UMLS CUI [1])
corticosteroid
Item
6. history of corticosteroid use in the four weeks preceding entry onto the clinical study.
boolean
C0001617 (UMLS CUI [1])
corticosteroids
Item
7. patients who require corticosteroids.
boolean
C0001617 (UMLS CUI [1])
hiv, hbsag
Item
8. evidence of hiv infection or aids and/or testing positive for hbsag.
boolean
C0019682 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
comorbidity
Item
9. any medical or psychiatric illness which in the opinion of the clinical investigators would compromise the patients ability to tolerate this treatment.
boolean
C0009488 (UMLS CUI [1])
anticoagulants
Item
10. patients who require anticoagulation.
boolean
C0003280 (UMLS CUI [1])
gender, ethnicity
Item
11. there is no exclusion for sex or ethnic background.
boolean
C0079399 (UMLS CUI [1])
C0015031 (UMLS CUI [2])
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