Colorectal cancer metastatic Advanced Biopsy
Item
1. advanced metastatic colorectal (stage iv) cancer verified by biopsy
boolean
C0948380 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Chest CT | MRI of Chest | CT of abdomen | MRI of abdomen | CT of Pelvis | MRI of Pelvis
Item
2. ct-scan or mri of thorax, abdomen and pelvis; within four (< 4) weeks before start of chemotherapy
boolean
C0202823 (UMLS CUI [1])
C0202826 (UMLS CUI [2])
C0412620 (UMLS CUI [3])
C0412693 (UMLS CUI [4])
C0412628 (UMLS CUI [5])
C0203201 (UMLS CUI [6])
Evaluable Disease | Measurable Disease Site Quantity | Site Size CT scan | Site Size MRI scan
Item
3. evaluable disease and one measurable site of disease according to recist 1.1 criteria (at least 10 mm for ct-scan or mri)
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1515974 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1515974 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Adult | Age
Item
4. male and female adults, age of 18 years or older
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
WHO performance status scale | Life Expectancy
Item
5. who performance status 0 < 2, and life expectancy > 3 months
boolean
C1298650 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Hematologic function
Item
6. adequate haematological function:
boolean
C0221130 (UMLS CUI [1])
Hemoglobin measurement
Item
1. haemoglobin (hb) > 100 g/l,
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
2. absolute neutrophil count (anc) > 1.5x109/l, and
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelets > 100x109/l
boolean
C0032181 (UMLS CUI [1])
Renal function | Liver function
Item
7. adequate renal and hepatic functions:
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Creatinine clearance measurement
Item
1. creatinine clearance > 50 ml/min,
boolean
C0373595 (UMLS CUI [1])
Serum total bilirubin measurement
Item
2. total bilirubin < 1.5 times upper limit of normal (uln),
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
3. aspartate transaminase (ast) and alanine transaminase (alt) < 3 times uln (and < 5 times uln in case of liver metastases)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative
Item
8. negative pregnancy test for females of child bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent
Item
9. willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods
Item
10. using adequate contraceptive measures
boolean
C0700589 (UMLS CUI [1])
Malignant Neoplasms | Exception Adenocarcinoma of large intestine | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
1. tumours other than colorectal adenocarcinomas (current or within the previous 5 years), with the exception for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1319315 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0699893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Adjuvant therapy Colorectal Carcinoma
Item
2. adjuvant treatment of crc within the last 12 months.
boolean
C0677850 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
CNS metastases
Item
3. evidence of central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
Resolution Lacking Intestinal Obstruction | Crohn Disease Uncontrolled | Ulcerative Colitis
Item
4. unresolved bowel obstruction or sub-obstruction, uncontrolled crohn's disease or ulcerative colitis
boolean
C1514893 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0021843 (UMLS CUI [1,3])
C0010346 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009324 (UMLS CUI [3])
Heart Disease | Congestive heart failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Cardiac Arrhythmia Serious Requirement Pharmacotherapy
Item
5. history of cardiac disease with a new your heart association (nyha) class ii or greater congestive heart failure, myocardial infarction or unstable angina in the past six (6) months prior to day 1 of treatment and serious arrhythmias requiring medication for treatment
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C1514873 (UMLS CUI [5,3])
C0013216 (UMLS CUI [5,4])
Diarrhea, severe, chronic
Item
6. current severe chronic diarrhoea
boolean
C1847423 (UMLS CUI [1])
Chronic infectious disease | Illness Serious Uncontrolled | Is etiology for Immunodeficiency
Item
7. current chronic infection or uncontrolled serious illness causing immunodeficiency
boolean
C0151317 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C1562189 (UMLS CUI [3,1])
C0021051 (UMLS CUI [3,2])
Illness Serious Uncontrolled | Medical condition Serious Uncontrolled
Item
8. any current uncontrolled serious illness or medical condition
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Major psychiatric illness | Major Depressive Disorder | Psychotic Disorder Major
Item
9. current major psychiatric disorder (e.g. major depression, psychosis)
boolean
C4534351 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C0033975 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Study Subject Participation Status | Investigational New Drugs
Item
10. participation in another clinical study with an imp within one (1) month prior to inclusion
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Intolerance to Fluoropyrimidine | Suggestive of Dihydropyrimidine Dehydrogenase Deficiency
Item
11. known intolerance to fluoropyrimidine therapy suggestive of dihydropyrimidine dehydrogenase deficiency
boolean
C1744706 (UMLS CUI [1,1])
C0596581 (UMLS CUI [1,2])
C0332299 (UMLS CUI [2,1])
C1959620 (UMLS CUI [2,2])
Suspicion Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Investigational New Drugs Related | Hypersensitivity Folate Derivative
Item
12. suspicion of hypersensitivity or allergy to the imp, or to products chemically related to the imp (i.e. folate derivatives)
boolean
C0242114 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C0178638 (UMLS CUI [3,2])
C1527240 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
13. female patients: currently pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])