ID

31998

Beschrijving

Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma; ODM derived from: https://clinicaltrials.gov/show/NCT00773097

Link

https://clinicaltrials.gov/show/NCT00773097

Trefwoorden

Versies (1)
  1. 10-10-18 10-10-18 -
Houder van rechten

See clinicaltrials.gov

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10 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Risk for Colorectal Cancer NCT00773097

Engels

Eligibility Risk for Colorectal Cancer NCT00773097

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 40 - 70 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
history of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).
Beschrijving

Criteria Quantity Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
1. colorectal adenoma(s) ≥ 1 cm in maximal diameter
Beschrijving

Colorectal Adenoma Diameter Maximal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1302401
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0205289
2. colorectal adenoma(s) with villous or tubulovillous histology
Beschrijving

Colorectal Villous Adenoma | Colorectal Tubulovillous Adenoma

Datatype

boolean

Alias
UMLS CUI [1]
C1333119
UMLS CUI [2]
C1333118
3. colorectal adenoma(s) with high-grade dysplasia
Beschrijving

Colorectal Adenoma with Severe Dysplasia

Datatype

boolean

Alias
UMLS CUI [1]
C1333108
willingness to avoid pregnancy or impregnate (see below) for the period of active study (1 year).
Beschrijving

Avoidance Pregnancy | Avoidance Impregnation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0015914
ecog performance status 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
hemoglobin greater than 95% of the lower limit of institutional normal. platelets
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
≥100,000/µl.
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
ast (sgot), alt (sgpt), alkaline phosphatase, total bilirubin, bun, creatinine ≤ 1.5x upper limit of institutional normal.
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Blood urea nitrogen measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0005845
UMLS CUI [6]
C0201976
ana < 1:160
Beschrijving

ANA

Datatype

boolean

Alias
UMLS CUI [1]
C0587178
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
receiving any other investigational agents.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
presence of an active acute or chronic infection
Beschrijving

Communicable Disease | Chronic infectious disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents.
Beschrijving

Allergic Reaction Compound Investigational New Drug Similar

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C2348205
history of heritable cancer syndrome (fap, hnpcc)
Beschrijving

Neoplastic Syndromes, Hereditary | FAP | HNPCC

Datatype

boolean

Alias
UMLS CUI [1]
C0027672
UMLS CUI [2]
C0032580
UMLS CUI [3]
C0009405
patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis.
Beschrijving

Autoimmune Disease | Inflammatory Bowel Disease | Lupus Erythematosus, Systemic | Rheumatoid Arthritis | Ankylosing spondylitis | Scleroderma | Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0003873
UMLS CUI [5]
C0038013
UMLS CUI [6]
C0011644
UMLS CUI [7]
C0026769
history of malignancy < 5 years prior to the registration/randomization evaluation, excluding non-melanoma skin cancer.
Beschrijving

Malignant Neoplasms | Exception Skin carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
any use of oral corticosteroids ≤ 12 weeks prior to registration/randomization.
Beschrijving

Adrenal Cortex Hormones Oral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
current or planned use of immunomodulators including: remicade, 6-mp (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs.
Beschrijving

Immunomodulators | Immunomodulators Planned | Remicade | Mercaptopurine | Methotrexate | Cyclosporine

Datatype

boolean

Alias
UMLS CUI [1]
C1527392
UMLS CUI [2,1]
C1527392
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C0723012
UMLS CUI [4]
C0000618
UMLS CUI [5]
C0025677
UMLS CUI [6]
C0010592
pregnant women, because the teratogenic or abortifacient effects of the study agents remain incompletely defined. breastfeeding women, because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Risk for Colorectal Cancer NCT00773097

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 40 - 70 years of age.
boolean
C0001779 (UMLS CUI [1])
Criteria Quantity Fulfill
Item
history of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Colorectal Adenoma Diameter Maximal
Item
1. colorectal adenoma(s) ≥ 1 cm in maximal diameter
boolean
C1302401 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0205289 (UMLS CUI [1,3])
Colorectal Villous Adenoma | Colorectal Tubulovillous Adenoma
Item
2. colorectal adenoma(s) with villous or tubulovillous histology
boolean
C1333119 (UMLS CUI [1])
C1333118 (UMLS CUI [2])
Colorectal Adenoma with Severe Dysplasia
Item
3. colorectal adenoma(s) with high-grade dysplasia
boolean
C1333108 (UMLS CUI [1])
Avoidance Pregnancy | Avoidance Impregnation
Item
willingness to avoid pregnancy or impregnate (see below) for the period of active study (1 year).
boolean
C0870186 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0015914 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin greater than 95% of the lower limit of institutional normal. platelets
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
≥100,000/µl.
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Blood urea nitrogen measurement | Creatinine measurement, serum
Item
ast (sgot), alt (sgpt), alkaline phosphatase, total bilirubin, bun, creatinine ≤ 1.5x upper limit of institutional normal.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0005845 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
ANA
Item
ana < 1:160
boolean
C0587178 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Communicable Disease | Chronic infectious disease
Item
presence of an active acute or chronic infection
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Allergic Reaction Compound Investigational New Drug Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Neoplastic Syndromes, Hereditary | FAP | HNPCC
Item
history of heritable cancer syndrome (fap, hnpcc)
boolean
C0027672 (UMLS CUI [1])
C0032580 (UMLS CUI [2])
C0009405 (UMLS CUI [3])
Autoimmune Disease | Inflammatory Bowel Disease | Lupus Erythematosus, Systemic | Rheumatoid Arthritis | Ankylosing spondylitis | Scleroderma | Multiple Sclerosis
Item
patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis.
boolean
C0004364 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
C0038013 (UMLS CUI [5])
C0011644 (UMLS CUI [6])
C0026769 (UMLS CUI [7])
Malignant Neoplasms | Exception Skin carcinoma
Item
history of malignancy < 5 years prior to the registration/randomization evaluation, excluding non-melanoma skin cancer.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Adrenal Cortex Hormones Oral
Item
any use of oral corticosteroids ≤ 12 weeks prior to registration/randomization.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Immunomodulators | Immunomodulators Planned | Remicade | Mercaptopurine | Methotrexate | Cyclosporine
Item
current or planned use of immunomodulators including: remicade, 6-mp (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs.
boolean
C1527392 (UMLS CUI [1])
C1527392 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0723012 (UMLS CUI [3])
C0000618 (UMLS CUI [4])
C0025677 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
Pregnancy | Breast Feeding
Item
pregnant women, because the teratogenic or abortifacient effects of the study agents remain incompletely defined. breastfeeding women, because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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