ID

13209

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00176761

Nyckelord

Versioner (1)
  1. 2016-01-24 2016-01-24 -
Uppladdad den

24 januari 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00176761

Engelsk

Eligibility Metastatic Colorectal Cancer NCT00176761

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

metastatic colorectal cancer

Datatyp

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.
Beskrivning

tumor location

Datatyp

boolean

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

karnofsky

Datatyp

boolean

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

life expectancy

Datatyp

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.
Beskrivning

measurable or evaluable disease

Datatyp

boolean

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

platelet count

Datatyp

boolean

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

wbc

Datatyp

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).
Beskrivning

chemotherapy, immunotherapy

Datatyp

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.
Beskrivning

irradiation

Datatyp

boolean

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

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

antitumor vaccines

Datatyp

boolean

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

autoimmune diseases

Datatyp

boolean

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

infection, bleeding

Datatyp

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.
Beskrivning

pregnancy or lactation

Datatyp

boolean

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

comorbidity

Datatyp

boolean

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

corticosteroid

Datatyp

boolean

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

corticosteroids

Datatyp

boolean

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

hiv, hbsag

Datatyp

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.
Beskrivning

comorbidity

Datatyp

boolean

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

anticoagulants

Datatyp

boolean

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

gender, ethnicity

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0015031
Tillbaka till toppen

Similar models

Eligibility Metastatic Colorectal Cancer NCT00176761

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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