Eligibility Cholangiocellular Carcinoma NCT01073839

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StudyEvent: Eligibility
1. Eligibility Cholangiocellular Carcinoma NCT01073839

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Adenocarcinoma Biliary tract | Neoplasms intrahepatic | Neoplasms Hilar | Carcinoma Involving Gallbladder

Item

1. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic and hilar tumors). carcinomas involving the gall bladder are allowed.

boolean

C0001418 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1512948 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C0205150 (UMLS CUI [3,2])
C0007097 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0016976 (UMLS CUI [4,3])

Complete excision macroscopic

Item

2. macroscopically complete resection within 8 weeks before start of chemotherapy.

boolean

C0015250 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])

Informed Consent

Item

3. written informed consent.

boolean

C0021430 (UMLS CUI [1])

WHO performance status scale

Item

4. health status: who performance status (ps) 0-1

boolean

C1298650 (UMLS CUI [1])

Age

Item

5. age >18 years

boolean

C0001779 (UMLS CUI [1])

Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Item

6. adequate renal function (creatinine clearance ≥ 60 ml/min, calculated according to the formula of cockcroft-gault)

boolean

C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])

Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement

Item

7. adequate hepatic function (bilirubin ≤ 3 x lun, ap ≤ 5 x lun, asat ≤ 5 x lun)

boolean

C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201899 (UMLS CUI [4])

Hematologic function | Neutrophil count | Platelet Count measurement

Item

8. adequate hematologic function: neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, hb

boolean

C0221130 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])

Hemoglobin measurement

Item

≥ 9,5 mg/dl

boolean

C0518015 (UMLS CUI [1])

Compliance behavior allowing TNM clinical staging | Proximity Geographic allowing TNM clinical staging | Compliance behavior allowing Therapeutic procedure | Proximity Geographic allowing Therapeutic procedure | Compliance behavior allowing Follow-up | Proximity Geographic allowing Follow-up

Item

9. patient compliance and geographic proximity allowing proper staging, treatment and follow-up.

boolean

C1321605 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1514583 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C1321605 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1514583 (UMLS CUI [4,1])
C1517526 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0087111 (UMLS CUI [4,4])
C1321605 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C1514583 (UMLS CUI [6,1])
C1517526 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C3274571 (UMLS CUI [6,4])

Item

10. women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during participation in the trial or during the 12 months thereafter. a negative pregnancy test before inclusion into the trial is required for women < 50 years. men who agree not to father a child during participation in the trial or during the 12 months thereafter.

boolean

C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0032992 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0001779 (UMLS CUI [5,2])
C0427780 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0035150 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Pregnancy | Breast Feeding

Item

1. pregnancy or breastfeeding women

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix Treated

Item

2. previous malignancy within 5 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer

boolean

C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])

Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Item

3. neutrophils < 1.5 x 109/l, platelets < 100 x 109/l, hb < 9,5 mg/dl

boolean

C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])

Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased

Item

4. bilirubin > 3 x lun, alat > 5 x lun, asat > 5 x lun

boolean

C0741494 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])

Estimation of creatinine clearance by Cockcroft-Gault formula

Item

5. creatinine clearance < 60 ml/min, calculated according to the formula of cockcroft-gault

boolean

C2711451 (UMLS CUI [1])

Prior Chemotherapy | gemcitabine

Item

6. prior chemotherapy with gemcitabine

boolean

C1514457 (UMLS CUI [1])
C0045093 (UMLS CUI [2])

Item

7. severe or uncontrolled cardiovascular disease (congestive heart failure nyha iii or iv, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmias)

boolean

C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0003811 (UMLS CUI [6])

Mental disorders Exclude Comprehension Study Protocol | Mental disorders Exclude Informed Consent

Item

8. psychiatric disorder precluding understanding of information of trial related topics and giving informed consent

boolean

C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])

Communicable Disease Uncontrolled

Item

9. active uncontrolled infection

boolean

C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])

Peripheral Neuropathy Pre-existing CTCAE Grades

Item

10. preexisting peripheral neuropathy (> grade 1)

boolean

C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])

Comorbidity Serious Study Subject Participation Status Impaired | Diabetic - poor control | Autoimmune Diseases

Item

11. serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease)

boolean

C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
C0421258 (UMLS CUI [2])
C0004364 (UMLS CUI [3])

Investigational New Drugs | Cancer treatment | Study Subject Participation Status

Item

12. concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry

boolean

C0013230 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C2348568 (UMLS CUI [3])

Hypersensitivity Investigational New Drugs

Item

13. known hypersensitivity to the study drugs

boolean

C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])

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Eligibility Cholangiocellular Carcinoma NCT01073839