Eligibility Colorectal Neoplasm NCT02244632

1 Formulários

StudyEvent: Eligibility
1. Eligibility Colorectal Neoplasm NCT02244632

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

Voltar ao início da página

ID

Descrição

Link

Palavras-chave

Versões (1)

Titular dos direitos

Transferido a

DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

Eligibility Colorectal Neoplasm NCT02244632