ID

44322

Description

Trial of Antigen Pulsed Dendritic Cells (APDC) in Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02503150

Link

https://clinicaltrials.gov/show/NCT02503150

Keywords

  1. 5/11/19 5/11/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Metastatic Colorectal Cancer NCT02503150

Eligibility Metastatic Colorectal Cancer NCT02503150

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed adenocarcinoma of the colorectum with metastatic lesions and received no previous therapy for metastatic lesions;
Description

Adenocarcinoma of large intestine | Prior Therapy Absent Metastatic Lesion

Data type

boolean

Alias
UMLS CUI [1]
C1319315
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1513183
2. be able to undergo surgical resection to obtain at least 1cm3 tumor tissues;
Description

Excision | Tumor tissue sample Quantity Size

Data type

boolean

Alias
UMLS CUI [1]
C0728940
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0456389
3. the patients are from 18-75 years old regardless of gender;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. an estimated life expectancy of more than 6 months with ecog≤2;
Description

Life Expectancy | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C1520224
5. adequate hepatic, renal, and bone marrow functions: neutrophilic granulocyte≥1.5×109/l, hb(hemoglobin)≥90g/l, plt(platelets)≥100×109/l, serum cr(creatinine)≤1.5-time upper normal limit, serum tbil(total bilirubin)≤1.5-time upper normal limit, both serum alt and ast(alanine aminotransferase and aspartate aminotransferase)≤2.5-time upper normal limit, hepatic metastases crc patients' serum alt/ast≤5-time upper normal limit;
Description

Liver function | Renal function | Bone Marrow function | Neutrophil count | Hemoglobin measurement | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
UMLS CUI [4]
C0200633
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0201976
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0201836
UMLS CUI [10]
C0201899
UMLS CUI [11]
C0494165
6. at least one measurable lesion after surgical resection (according to the standard of recist1.1 version: response evaluation criteria in solid tumors 1.1 version);
Description

Measurable Disease Quantity | Status post Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0728940
7. written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. severe (ie, active) heart disease, such as coronary heart disease symptoms, the new york heart association (nyha) ii-class or more serious congestive heart failure or severe arrhythmia requiring medication intervention, or history of myocardial infarction within the last 12 months; severe pulmonary dysfunction; peripheral neuropathy; unstable hypertension;
Description

Heart Disease Severe | Symptoms Coronary heart disease | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Severe | Requirement Pharmacotherapy | Myocardial Infarction | Dysfunction Pulmonary Severe | Peripheral Neuropathy | Hypertensive disease Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0010068
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0013216
UMLS CUI [6]
C0027051
UMLS CUI [7,1]
C3887504
UMLS CUI [7,2]
C2709248
UMLS CUI [7,3]
C0205082
UMLS CUI [8]
C0031117
UMLS CUI [9,1]
C0020538
UMLS CUI [9,2]
C0443343
2. metastases lesions> 50% of liver volume;
Description

Metastatic Lesion Liver Volume Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1513183
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0449468
UMLS CUI [1,4]
C0439165
3. autoimmune diseases, organ transplantation requiring immunosuppressive therapy and patients requiring long-term systemic corticosteroid therapy;
Description

Autoimmune Diseases | Organ Transplantation Requirement Therapeutic immunosuppression | Requirement Systemic Corticosteroid Therapy Long-term

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0029216
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021079
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C4053960
UMLS CUI [3,3]
C0443252
4. history of other malignant diseases (except cured basal cell carcinoma and cervical carcinoma in situ) in the last 5 years;
Description

Malignant Neoplasms | Exception Basal cell carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1880198
5. pregnant or lactating women (women at childbearing age in the baseline pregnancy test positive or pregnancy test not examined. menopausal women have menopause at least 12 months);
Description

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test positive | Childbearing Potential Pregnancy Test Absent | Menopausal Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0240802
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0032976
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C3829127
6. acute or chronic infectious diseases in active phase; severe uncontrolled infection, or other serious uncontrolled concomitant diseases;
Description

Communicable Disease | Chronic infectious disease | Communicable Disease Severe Uncontrolled | Comorbidity Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0205318
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0205318
7. definite history of allergy or allergic constitutions;
Description

History of allergies | Patient constitution allergic

Data type

boolean

Alias
UMLS CUI [1]
C0489531
UMLS CUI [2,1]
C0683521
UMLS CUI [2,2]
C0700624
8. chemotherapy, radiotherapy or immunotherapy within four weeks;
Description

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
9. administration of other investigational drugs or procedures within four weeks.
Description

Investigational New Drugs | Procedures Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1517586

Similar models

Eligibility Metastatic Colorectal Cancer NCT02503150

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine | Prior Therapy Absent Metastatic Lesion
Item
1. histologically confirmed adenocarcinoma of the colorectum with metastatic lesions and received no previous therapy for metastatic lesions;
boolean
C1319315 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513183 (UMLS CUI [2,3])
Excision | Tumor tissue sample Quantity Size
Item
2. be able to undergo surgical resection to obtain at least 1cm3 tumor tissues;
boolean
C0728940 (UMLS CUI [1])
C0475358 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
Age
Item
3. the patients are from 18-75 years old regardless of gender;
boolean
C0001779 (UMLS CUI [1])
Life Expectancy | ECOG performance status
Item
4. an estimated life expectancy of more than 6 months with ecog≤2;
boolean
C0023671 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Liver function | Renal function | Bone Marrow function | Neutrophil count | Hemoglobin measurement | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
5. adequate hepatic, renal, and bone marrow functions: neutrophilic granulocyte≥1.5×109/l, hb(hemoglobin)≥90g/l, plt(platelets)≥100×109/l, serum cr(creatinine)≤1.5-time upper normal limit, serum tbil(total bilirubin)≤1.5-time upper normal limit, both serum alt and ast(alanine aminotransferase and aspartate aminotransferase)≤2.5-time upper normal limit, hepatic metastases crc patients' serum alt/ast≤5-time upper normal limit;
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
C0200633 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0494165 (UMLS CUI [11])
Measurable Disease Quantity | Status post Excision
Item
6. at least one measurable lesion after surgical resection (according to the standard of recist1.1 version: response evaluation criteria in solid tumors 1.1 version);
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
Informed Consent
Item
7. written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Disease Severe | Symptoms Coronary heart disease | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Severe | Requirement Pharmacotherapy | Myocardial Infarction | Dysfunction Pulmonary Severe | Peripheral Neuropathy | Hypertensive disease Unstable
Item
1. severe (ie, active) heart disease, such as coronary heart disease symptoms, the new york heart association (nyha) ii-class or more serious congestive heart failure or severe arrhythmia requiring medication intervention, or history of myocardial infarction within the last 12 months; severe pulmonary dysfunction; peripheral neuropathy; unstable hypertension;
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0010068 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0013216 (UMLS CUI [5,2])
C0027051 (UMLS CUI [6])
C3887504 (UMLS CUI [7,1])
C2709248 (UMLS CUI [7,2])
C0205082 (UMLS CUI [7,3])
C0031117 (UMLS CUI [8])
C0020538 (UMLS CUI [9,1])
C0443343 (UMLS CUI [9,2])
Metastatic Lesion Liver Volume Percentage
Item
2. metastases lesions> 50% of liver volume;
boolean
C1513183 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Autoimmune Diseases | Organ Transplantation Requirement Therapeutic immunosuppression | Requirement Systemic Corticosteroid Therapy Long-term
Item
3. autoimmune diseases, organ transplantation requiring immunosuppressive therapy and patients requiring long-term systemic corticosteroid therapy;
boolean
C0004364 (UMLS CUI [1])
C0029216 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021079 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C4053960 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
Malignant Neoplasms | Exception Basal cell carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured
Item
4. history of other malignant diseases (except cured basal cell carcinoma and cervical carcinoma in situ) in the last 5 years;
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test positive | Childbearing Potential Pregnancy Test Absent | Menopausal Status
Item
5. pregnant or lactating women (women at childbearing age in the baseline pregnancy test positive or pregnancy test not examined. menopausal women have menopause at least 12 months);
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0240802 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C3829127 (UMLS CUI [5])
Communicable Disease | Chronic infectious disease | Communicable Disease Severe Uncontrolled | Comorbidity Serious Uncontrolled
Item
6. acute or chronic infectious diseases in active phase; severe uncontrolled infection, or other serious uncontrolled concomitant diseases;
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
History of allergies | Patient constitution allergic
Item
7. definite history of allergy or allergic constitutions;
boolean
C0489531 (UMLS CUI [1])
C0683521 (UMLS CUI [2,1])
C0700624 (UMLS CUI [2,2])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
8. chemotherapy, radiotherapy or immunotherapy within four weeks;
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Investigational New Drugs | Procedures Investigational
Item
9. administration of other investigational drugs or procedures within four weeks.
boolean
C0013230 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])

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