ID

30652

Beschreibung

Alpha-type-1 Dendritic Cell-based Vaccines in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00558051

Link

https://clinicaltrials.gov/show/NCT00558051

Stichworte

Versionen (1)
  1. 19.06.18 19.06.18 -
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See clinicaltrials.gov

Hochgeladen am

19. Juni 2018

DOI

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Eligibility Metastatic Colorectal Cancer NCT00558051

Englisch

Eligibility Metastatic Colorectal Cancer NCT00558051

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic colorectal cancer with minimal evidence of disease or resectable metastases (to include extra-hepatic metastases).
Beschreibung

Colorectal cancer metastatic | Neoplasm Metastasis Resectable Evidence Minimal | Neoplasm Metastasis Extrahepatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0948380
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1514888
UMLS CUI [2,3]
C3887511
UMLS CUI [2,4]
C0547040
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1517058
availability of metastatic tumor material, from hepatic metastasis and additional sites, that can be resected under sterile conditions for autologous vaccine preparation (not all tumors harvested will be of sufficient quantity or quality to make vaccine, therefore some subjects may not receive vaccine).
Beschreibung

Availability of Tumor tissue sample metastatic | Availability of Secondary malignant neoplasm of liver Specimen | Availability of Specimen Site Additional | Autogenous vaccine preparation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C1522484
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0494165
UMLS CUI [2,3]
C0370003
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C0370003
UMLS CUI [3,3]
C1515974
UMLS CUI [3,4]
C1524062
UMLS CUI [4]
C0201667
no chemotherapy, radiotherapy, major surgery, or biologic therapy for their malignancy in the 4 weeks prior to the vaccine administration and must have recovered from all side effects.
Beschreibung

Absence Chemotherapy Malignant Neoplasms | Absence Therapeutic radiology procedure Malignant Neoplasms | Absence Major surgery Malignant Neoplasms | Absence Biological treatment Malignant Neoplasms | Side effects Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0679637
UMLS CUI [3,3]
C0006826
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C1531518
UMLS CUI [4,3]
C0006826
UMLS CUI [5,1]
C0879626
UMLS CUI [5,2]
C1115804
an ecog performance standard of 0, 1 or 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hepatic function as evidenced by bilirubin < 2.0 mg/dl and a pt < 2 seconds of the upper limit of normal.
Beschreibung

Liver function | Serum total bilirubin measurement | Prothrombin time assay

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0033707
age equal to 18 years or older and greater than 30 kg.
Beschreibung

Age | Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
platelet counts greater than 100,000, a hematocrit > 27.0, a white blood count > 3000/µl, and a creatinine less than or equal to 1.5 mg/dl or a creatinine clearance of > 60 ml/min.
Beschreibung

Platelet Count measurement | Hematocrit level | White Blood Cell Count procedure | Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0518014
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0373595
aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits and risks, and willing to sign an informed consent.
Beschreibung

Awareness Neoplastic disease | Awareness Investigational Therapy | Awareness Alternative medical treatment | Awareness Risks and Benefits | Informed Consent Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004448
UMLS CUI [1,2]
C1882062
UMLS CUI [2,1]
C0004448
UMLS CUI [2,2]
C0949266
UMLS CUI [3,1]
C0004448
UMLS CUI [3,2]
C0683466
UMLS CUI [4,1]
C0004448
UMLS CUI [4,2]
C0687742
UMLS CUI [5,1]
C0021430
UMLS CUI [5,2]
C0600109
patients must be able to understand and be willing to sign a written informed consent document.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 4 weeks after removal from immunosuppressive treatment. subjects on maintenance steroids because of adrenal insufficiency are eligible.
Beschreibung

Immunosuppressive Agents Systemic | Systemic steroids | Eligibility Steroids Adrenal gland hypofunction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C2825233
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0038317
UMLS CUI [3,3]
C0001623
subjects with severely abnormal liver function tests [ast (sgot), alt (sgpt), ggt, alk.phos, ldh, and total bilirubin greater than 2 x uln]
Beschreibung

Liver function tests abnormal Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Serum alkaline phosphatase raised | Serum lactic dehydrogenase increased | Elevated total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151766
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151662
UMLS CUI [5]
C1314665
UMLS CUI [6]
C0750858
UMLS CUI [7]
C0741494
subjects with uncontrolled pain.
Beschreibung

Uncontrolled pain

Datentyp

boolean

Alias
UMLS CUI [1]
C0747149
subjects with active autoimmune disease, positive serology for hiv, hbv, or hcv (testing will be performed with fda licensed blood donor tests).
Beschreibung

Autoimmune Diseases | HIV Seropositivity | Serology positive Hepatitis B Virus | Serology positive Hepatitis C virus | Blood donor Testing

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0019699
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0019169
UMLS CUI [4,1]
C0242089
UMLS CUI [4,2]
C0220847
UMLS CUI [5,1]
C0005795
UMLS CUI [5,2]
C0039593
subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix).
Beschreibung

Malignant Neoplasms Additional | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
subjects who are allergic to or develop an allergy to heparin.
Beschreibung

Heparin allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571776
subjects who are pregnant.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
subjects who have sensitivity to drugs that provide local anesthesia.
Beschreibung

Hypersensitivity Local Anesthetics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002934
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Ähnliche Modelle

Eligibility Metastatic Colorectal Cancer NCT00558051

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal cancer metastatic | Neoplasm Metastasis Resectable Evidence Minimal | Neoplasm Metastasis Extrahepatic
Item
histologically or cytologically confirmed metastatic colorectal cancer with minimal evidence of disease or resectable metastases (to include extra-hepatic metastases).
boolean
C0948380 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
C0547040 (UMLS CUI [2,4])
C0027627 (UMLS CUI [3,1])
C1517058 (UMLS CUI [3,2])
Availability of Tumor tissue sample metastatic | Availability of Secondary malignant neoplasm of liver Specimen | Availability of Specimen Site Additional | Autogenous vaccine preparation
Item
availability of metastatic tumor material, from hepatic metastasis and additional sites, that can be resected under sterile conditions for autologous vaccine preparation (not all tumors harvested will be of sufficient quantity or quality to make vaccine, therefore some subjects may not receive vaccine).
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C0494165 (UMLS CUI [2,2])
C0370003 (UMLS CUI [2,3])
C0470187 (UMLS CUI [3,1])
C0370003 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
C1524062 (UMLS CUI [3,4])
C0201667 (UMLS CUI [4])
Absence Chemotherapy Malignant Neoplasms | Absence Therapeutic radiology procedure Malignant Neoplasms | Absence Major surgery Malignant Neoplasms | Absence Biological treatment Malignant Neoplasms | Side effects Patient recovered
Item
no chemotherapy, radiotherapy, major surgery, or biologic therapy for their malignancy in the 4 weeks prior to the vaccine administration and must have recovered from all side effects.
boolean
C0332197 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0679637 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C1531518 (UMLS CUI [4,2])
C0006826 (UMLS CUI [4,3])
C0879626 (UMLS CUI [5,1])
C1115804 (UMLS CUI [5,2])
ECOG performance status
Item
an ecog performance standard of 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Prothrombin time assay
Item
adequate hepatic function as evidenced by bilirubin < 2.0 mg/dl and a pt < 2 seconds of the upper limit of normal.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
Age | Body Weight
Item
age equal to 18 years or older and greater than 30 kg.
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Platelet Count measurement | Hematocrit level | White Blood Cell Count procedure | Creatinine measurement, serum | Creatinine clearance measurement
Item
platelet counts greater than 100,000, a hematocrit > 27.0, a white blood count > 3000/µl, and a creatinine less than or equal to 1.5 mg/dl or a creatinine clearance of > 60 ml/min.
boolean
C0032181 (UMLS CUI [1])
C0518014 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
Awareness Neoplastic disease | Awareness Investigational Therapy | Awareness Alternative medical treatment | Awareness Risks and Benefits | Informed Consent Willing
Item
aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits and risks, and willing to sign an informed consent.
boolean
C0004448 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
C0004448 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
C0004448 (UMLS CUI [3,1])
C0683466 (UMLS CUI [3,2])
C0004448 (UMLS CUI [4,1])
C0687742 (UMLS CUI [4,2])
C0021430 (UMLS CUI [5,1])
C0600109 (UMLS CUI [5,2])
Informed Consent
Item
patients must be able to understand and be willing to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Immunosuppressive Agents Systemic | Systemic steroids | Eligibility Steroids Adrenal gland hypofunction
Item
subjects currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 4 weeks after removal from immunosuppressive treatment. subjects on maintenance steroids because of adrenal insufficiency are eligible.
boolean
C0021081 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2])
C1548635 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C0001623 (UMLS CUI [3,3])
Liver function tests abnormal Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Serum alkaline phosphatase raised | Serum lactic dehydrogenase increased | Elevated total bilirubin
Item
subjects with severely abnormal liver function tests [ast (sgot), alt (sgpt), ggt, alk.phos, ldh, and total bilirubin greater than 2 x uln]
boolean
C0151766 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151662 (UMLS CUI [4])
C1314665 (UMLS CUI [5])
C0750858 (UMLS CUI [6])
C0741494 (UMLS CUI [7])
Uncontrolled pain
Item
subjects with uncontrolled pain.
boolean
C0747149 (UMLS CUI [1])
Autoimmune Diseases | HIV Seropositivity | Serology positive Hepatitis B Virus | Serology positive Hepatitis C virus | Blood donor Testing
Item
subjects with active autoimmune disease, positive serology for hiv, hbv, or hcv (testing will be performed with fda licensed blood donor tests).
boolean
C0004364 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
C0242089 (UMLS CUI [3,1])
C0019169 (UMLS CUI [3,2])
C0242089 (UMLS CUI [4,1])
C0220847 (UMLS CUI [4,2])
C0005795 (UMLS CUI [5,1])
C0039593 (UMLS CUI [5,2])
Malignant Neoplasms Additional | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix).
boolean
C0006826 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Heparin allergy
Item
subjects who are allergic to or develop an allergy to heparin.
boolean
C0571776 (UMLS CUI [1])
Pregnancy
Item
subjects who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity Local Anesthetics
Item
subjects who have sensitivity to drugs that provide local anesthesia.
boolean
C0020517 (UMLS CUI [1,1])
C0002934 (UMLS CUI [1,2])
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