ID

13209

Description

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

Link

https://clinicaltrials.gov/show/NCT00176761

Keywords

Versions (1)
  1. 1/24/16 1/24/16 -
Uploaded on

January 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00176761

English

Eligibility Metastatic Colorectal Cancer NCT00176761

1 forms  
Inclusion Criteria
Description

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.
Description

metastatic colorectal cancer

Data type

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.
Description

tumor location

Data type

boolean

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

karnofsky

Data type

boolean

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

life expectancy

Data type

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.
Description

measurable or evaluable disease

Data type

boolean

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

platelet count

Data type

boolean

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

wbc

Data type

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).
Description

chemotherapy, immunotherapy

Data type

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.
Description

irradiation

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

antitumor vaccines

Data type

boolean

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

autoimmune diseases

Data type

boolean

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

infection, bleeding

Data type

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.
Description

pregnancy or lactation

Data type

boolean

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

comorbidity

Data type

boolean

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

corticosteroid

Data type

boolean

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

corticosteroids

Data type

boolean

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

hiv, hbsag

Data type

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.
Description

comorbidity

Data type

boolean

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

anticoagulants

Data type

boolean

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

gender, ethnicity

Data type

boolean

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

Eligibility Metastatic Colorectal Cancer NCT00176761

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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