ID

15945

Beskrivning

Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus (ORCHIDEE); ODM derived from: https://clinicaltrials.gov/show/NCT02338570

Länk

https://clinicaltrials.gov/show/NCT02338570

Nyckelord

Versioner (1)
  1. 2016-06-20 2016-06-20 -
Uppladdad den

20 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT02338570

Engelsk

Eligibility Renal Cell Carcinoma NCT02338570

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female, aged 18 years or older, with histologically or cytologically confirmed mrcc (clear cell or not clear cell);
Beskrivning

Age | Metastatic Renal Cell Cancer | Clear-cell metastatic renal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0278678
UMLS CUI [3]
C2931852
2. ecog-ps 0-1-2;
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
3. with target and/or non-target lesions according to response evaluation criteria in solid tumours (recist) 1.1;
Beskrivning

Target Lesion Identification | Non-Target Lesion Identification

Datatyp

boolean

Alias
UMLS CUI [1]
C2986546
UMLS CUI [2]
C2986547
4. following failure of a previous treatment with vegf-targeted therapy (e.g. sunitinib, sorafenib, pazopanib, or bevacizumab+interferon);
Beskrivning

Prior Therapy failed | Therapeutic procedure VEGF targeted | sunitinib | sorafenib | pazopanib | bevacizumab Interferon

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0078058
UMLS CUI [2,3]
C0599894
UMLS CUI [3]
C1176020
UMLS CUI [4]
C1516119
UMLS CUI [5]
C1831796
UMLS CUI [6,1]
C0796392
UMLS CUI [6,2]
C0021747
5. for whom a decision has been taken to initiate everolimus treatment or patient currently receiving treatment with everolimus by a period of time ≤30 days;
Beskrivning

Therapeutic procedure everolimus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0541315
6. willing and able to comply with follow-up and all other protocol requirements and able to commence treatment within 21 days;
Beskrivning

Compliance behavior Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
7. written informed consent obtained before any screening procedure and according to local guidelines.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who meet any of the following criteria will be excluded from study entry:
Beskrivning

criteria Following | Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0332282
UMLS CUI [2]
C1550543
1. previous treatment with everolimus or at the date of written informed consent provision receiving everolimus by more than 30 days;
Beskrivning

Prior Therapy everolimus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0541315
2. symptomatic central nervous system metastases. patients may be eligible if the central nervous system metastases have been adequately treated (surgery or radiotherapy), and do not require ongoing corticosteroids for control of symptoms and have had no evidence of progression for at least three months;
Beskrivning

CNS metastases Symptomatic | Operative Surgical Procedures | Therapeutic radiology procedure | Adrenal Cortex Hormones Symptom control | No evidence of Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C1274136
UMLS CUI [5,1]
C0332125
UMLS CUI [5,2]
C0242656
3. other malignancy diagnosed within the last 5 years, except the following, if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (t1 and g1 or t1 and g2), stage 1 cervical cancer;
Beskrivning

Malignant Neoplasms Other | Squamous cell carcinoma Superficial | Basal cell carcinoma | Carcinoma of urinary bladder, superficial | cervical cancer | TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C0205124
UMLS CUI [3]
C0007117
UMLS CUI [4]
C1336527
UMLS CUI [5]
C4048328
UMLS CUI [6]
C3258246
4. treatment with an investigational agent in the past 4 weeks;
Beskrivning

Therapeutic procedure Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013230
5. clinically relevant human immunodeficiency virus, hepatitis b virus, hepatitis c virus infection;
Beskrivning

HIV Infections | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
6. non adequate liver function as shown by:
Beskrivning

Liver function Inadequate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205412
serum or plasma alt and ast >3.0x upper limit of normal (uln) >5 if hepatic metastases are present;
Beskrivning

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0494165
serum or plasma total bilirubin: >1.5xuln (excepted for patients with gilbert's syndrome);
Beskrivning

Bilirubin, total measurement | Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0017551
7. non adequate renal function as shown by serum creatinine >2.5xuln;
Beskrivning

Renal function Inadequate | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0201976
8. any of the following in the last year: myocardial infarction, severe/ unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack or pulmonary embolism;
Beskrivning

Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010055
UMLS CUI [5]
C3495795
UMLS CUI [6]
C0742758
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0007787
UMLS CUI [9]
C0034065
9. ongoing grade ≥2 cardiac dysrhythmias, atrial fibrillation of any grade or prolongation of the corrected qt interval to >450 msec for males or >470 msec for females;
Beskrivning

Cardiac Arrhythmia Continuous | Atrial Fibrillation | CTCAE | QT corrected interval prolonged | Gender

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0549178
UMLS CUI [2]
C0004238
UMLS CUI [3]
C1516728
UMLS CUI [4]
C0855333
UMLS CUI [5]
C0079399
10. pregnancy (negative pregnancy test required for women of child-bearing potential), breast feeding;
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
11. inadequate contraception. women must be post-menopausal, surgically sterile, or use a reliable form of contraception. men must be surgically sterile or use a barrier method of contraception;
Beskrivning

Contraceptive methods Inadequate | Postmenopausal state | Female Sterilization | Contraceptive methods | Male sterilization | Contraception, Barrier

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0024559
UMLS CUI [6]
C0004764
12. known allergy or hypersensitivity to everolimus or its excipients.
Beskrivning

Hypersensitivity everolimus | Hypersensitivity everolimus Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0541315
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0541315
UMLS CUI [2,3]
C0015237
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Similar models

Eligibility Renal Cell Carcinoma NCT02338570

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Metastatic Renal Cell Cancer | Clear-cell metastatic renal cell carcinoma
Item
1. male or female, aged 18 years or older, with histologically or cytologically confirmed mrcc (clear cell or not clear cell);
boolean
C0001779 (UMLS CUI [1])
C0278678 (UMLS CUI [2])
C2931852 (UMLS CUI [3])
ECOG performance status
Item
2. ecog-ps 0-1-2;
boolean
C1520224 (UMLS CUI [1])
Target Lesion Identification | Non-Target Lesion Identification
Item
3. with target and/or non-target lesions according to response evaluation criteria in solid tumours (recist) 1.1;
boolean
C2986546 (UMLS CUI [1])
C2986547 (UMLS CUI [2])
Prior Therapy failed | Therapeutic procedure VEGF targeted | sunitinib | sorafenib | pazopanib | bevacizumab Interferon
Item
4. following failure of a previous treatment with vegf-targeted therapy (e.g. sunitinib, sorafenib, pazopanib, or bevacizumab+interferon);
boolean
C1514463 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0078058 (UMLS CUI [2,2])
C0599894 (UMLS CUI [2,3])
C1176020 (UMLS CUI [3])
C1516119 (UMLS CUI [4])
C1831796 (UMLS CUI [5])
C0796392 (UMLS CUI [6,1])
C0021747 (UMLS CUI [6,2])
Therapeutic procedure everolimus
Item
5. for whom a decision has been taken to initiate everolimus treatment or patient currently receiving treatment with everolimus by a period of time ≤30 days;
boolean
C0087111 (UMLS CUI [1,1])
C0541315 (UMLS CUI [1,2])
Compliance behavior Study Protocol
Item
6. willing and able to comply with follow-up and all other protocol requirements and able to commence treatment within 21 days;
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed consent
Item
7. written informed consent obtained before any screening procedure and according to local guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
criteria Following | Fulfill
Item
patients who meet any of the following criteria will be excluded from study entry:
boolean
C0243161 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C1550543 (UMLS CUI [2])
Prior Therapy everolimus
Item
1. previous treatment with everolimus or at the date of written informed consent provision receiving everolimus by more than 30 days;
boolean
C1514463 (UMLS CUI [1,1])
C0541315 (UMLS CUI [1,2])
CNS metastases Symptomatic | Operative Surgical Procedures | Therapeutic radiology procedure | Adrenal Cortex Hormones Symptom control | No evidence of Disease Progression
Item
2. symptomatic central nervous system metastases. patients may be eligible if the central nervous system metastases have been adequately treated (surgery or radiotherapy), and do not require ongoing corticosteroids for control of symptoms and have had no evidence of progression for at least three months;
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C1274136 (UMLS CUI [4,2])
C0332125 (UMLS CUI [5,1])
C0242656 (UMLS CUI [5,2])
Malignant Neoplasms Other | Squamous cell carcinoma Superficial | Basal cell carcinoma | Carcinoma of urinary bladder, superficial | cervical cancer | TNM clinical staging
Item
3. other malignancy diagnosed within the last 5 years, except the following, if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (t1 and g1 or t1 and g2), stage 1 cervical cancer;
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0007137 (UMLS CUI [2,1])
C0205124 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3])
C1336527 (UMLS CUI [4])
C4048328 (UMLS CUI [5])
C3258246 (UMLS CUI [6])
Therapeutic procedure Investigational New Drugs
Item
4. treatment with an investigational agent in the past 4 weeks;
boolean
C0087111 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
HIV Infections | Hepatitis B | Hepatitis C
Item
5. clinically relevant human immunodeficiency virus, hepatitis b virus, hepatitis c virus infection;
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Liver function Inadequate
Item
6. non adequate liver function as shown by:
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
serum or plasma alt and ast >3.0x upper limit of normal (uln) >5 if hepatic metastases are present;
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Bilirubin, total measurement | Gilbert Disease
Item
serum or plasma total bilirubin: >1.5xuln (excepted for patients with gilbert's syndrome);
boolean
C0201913 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
Renal function Inadequate | Creatinine measurement, serum
Item
7. non adequate renal function as shown by serum creatinine >2.5xuln;
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism
Item
8. any of the following in the last year: myocardial infarction, severe/ unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack or pulmonary embolism;
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C3495795 (UMLS CUI [5])
C0742758 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0007787 (UMLS CUI [8])
C0034065 (UMLS CUI [9])
Cardiac Arrhythmia Continuous | Atrial Fibrillation | CTCAE | QT corrected interval prolonged | Gender
Item
9. ongoing grade ≥2 cardiac dysrhythmias, atrial fibrillation of any grade or prolongation of the corrected qt interval to >450 msec for males or >470 msec for females;
boolean
C0003811 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2])
C1516728 (UMLS CUI [3])
C0855333 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative
Item
10. pregnancy (negative pregnancy test required for women of child-bearing potential), breast feeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Contraceptive methods Inadequate | Postmenopausal state | Female Sterilization | Contraceptive methods | Male sterilization | Contraception, Barrier
Item
11. inadequate contraception. women must be post-menopausal, surgically sterile, or use a reliable form of contraception. men must be surgically sterile or use a barrier method of contraception;
boolean
C0700589 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0024559 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
Hypersensitivity everolimus | Hypersensitivity everolimus Excipient
Item
12. known allergy or hypersensitivity to everolimus or its excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0541315 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0541315 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
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