Eligibility Criteria

Inclusion and exclusion criteria
Beschreibung

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*5.0 ELIGIBILITY* *5.1 Patient population* This protocol is designed to collect biospecimens with annotated clinical data from patients with advanced or refractory cancer.
Beschreibung

Elig.phs000673.v4.p1.1

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C2347026
UMLS CUI [1,4]
C3645564
UMLS CUI [1,5]
C1516606
UMLS CUI [1,6]
C0877373
UMLS CUI [1,7]
C0677936
*5.2 5.2 Inclusion Criteria: (Must satisfy all criteria and either #3 or #4)*
Beschreibung

Elig.phs000673.v4.p1.2

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
A histologically or cytologically confirmed diagnosis of cancer
Beschreibung

Elig.phs000673.v4.p1.3

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679557
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C1298647
Patients with any advanced or refractory malignancy
Beschreibung

Elig.phs000673.v4.p1.4

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877373
UMLS CUI [1,2]
C0677936
Patients are undergoing standard of care surgeries or procedures where specimens will be first used for routine pathologic assessment and only then will leftover tissue be used for research purposes **OR**
Beschreibung

Elig.phs000673.v4.p1.5

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C2347026
UMLS CUI [1,5]
C0920316
UMLS CUI [1,6]
C1317598
UMLS CUI [1,7]
C0445107
UMLS CUI [1,8]
C0475358
UMLS CUI [1,9]
C0242481
Patients must have tumor suitable for biopsy (as assessed by trained specialists in interventional radiology) and Patients are medically fit to undergo a tissue biopsy or surgical procedure to get tumor tissue *OR* If Patients do not have a tumor suitable for biopsy but have another tissue available for molecular evaluation
Beschreibung

Elig.phs000673.v4.p1.6

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0005558
UMLS CUI [1,4]
C1299581
UMLS CUI [1,5]
C4707158
UMLS CUI [1,6]
C0005558
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0475358
UMLS CUI [2,3]
C1548787
UMLS CUI [2,4]
C0005558
UMLS CUI [2,5]
C0470187
UMLS CUI [2,6]
C0205394
UMLS CUI [2,7]
C0040300
UMLS CUI [2,8]
C1513380
Older than or equal to 18 years of age
Beschreibung

Elig.phs000673.v4.p1.7

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
Procedure-specific signed informed consent prior to initiation of any study-related procedures
Beschreibung

Elig.phs000673.v4.p1.8

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C5421123
Women and minorities are included in this protocol
Beschreibung

Elig.phs000673.v4.p1.9

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0043210
UMLS CUI [1,3]
C0026192
Patients with multiple malignancies remain eligible
Beschreibung

Elig.phs000673.v4.p1.10

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0346429
Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible
Beschreibung

Elig.phs000673.v4.p1.11

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0019247
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0262926
UMLS CUI [2,3]
C0332299
UMLS CUI [2,4]
C0019247
UMLS CUI [2,5]
C0006826
*5.3 Exclusion Criteria: *
Beschreibung

Elig.phs000673.v4.p1.12

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
It is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo tissue biopsy
Beschreibung

Elig.phs000673.v4.p1.13

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C1710470
UMLS CUI [1,4]
C0679006
UMLS CUI [1,5]
C4708589
Patients who are incarcerated are not eligible to participate
Beschreibung

Elig.phs000673.v4.p1.14

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205255
Women who are pregnant
Beschreibung

Elig.phs000673.v4.p1.15

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0032961
*5.4 Women of childbearing age* For women of childbearing age, there are no screening requirements. We note that most patients entering this study are seeking eligibility for therapy or other clinical trial, in which case they are generally asked to avoiding becoming pregnant and even exercise some form of contraception by their medical oncologist. For women of childbearing age, their referring medical oncologist will discuss necessity or role for appropriate contraception. This is not part of the study activity, nor is it required for participation.
Beschreibung

Elig.phs000673.v4.p1.16

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0220908
UMLS CUI [1,4]
C0700589

Ähnliche Modelle

Eligibility Criteria

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Elig.phs000673.v4.p1.1
Item
*5.0 ELIGIBILITY* *5.1 Patient population* This protocol is designed to collect biospecimens with annotated clinical data from patients with advanced or refractory cancer.
boolean
C1516637 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C2347026 (UMLS CUI [1,3])
C3645564 (UMLS CUI [1,4])
C1516606 (UMLS CUI [1,5])
C0877373 (UMLS CUI [1,6])
C0677936 (UMLS CUI [1,7])
Elig.phs000673.v4.p1.2
Item
*5.2 5.2 Inclusion Criteria: (Must satisfy all criteria and either #3 or #4)*
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs000673.v4.p1.3
Item
A histologically or cytologically confirmed diagnosis of cancer
boolean
C0679557 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1298647 (UMLS CUI [1,3])
Elig.phs000673.v4.p1.4
Item
Patients with any advanced or refractory malignancy
boolean
C0877373 (UMLS CUI [1,1])
C0677936 (UMLS CUI [1,2])
Elig.phs000673.v4.p1.5
Item
Patients are undergoing standard of care surgeries or procedures where specimens will be first used for routine pathologic assessment and only then will leftover tissue be used for research purposes **OR**
boolean
C2936643 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C2347026 (UMLS CUI [1,4])
C0920316 (UMLS CUI [1,5])
C1317598 (UMLS CUI [1,6])
C0445107 (UMLS CUI [1,7])
C0475358 (UMLS CUI [1,8])
C0242481 (UMLS CUI [1,9])
Elig.phs000673.v4.p1.6
Item
Patients must have tumor suitable for biopsy (as assessed by trained specialists in interventional radiology) and Patients are medically fit to undergo a tissue biopsy or surgical procedure to get tumor tissue *OR* If Patients do not have a tumor suitable for biopsy but have another tissue available for molecular evaluation
boolean
C0475358 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C1299581 (UMLS CUI [1,4])
C4707158 (UMLS CUI [1,5])
C0005558 (UMLS CUI [1,6])
C1298908 (UMLS CUI [2,1])
C0475358 (UMLS CUI [2,2])
C1548787 (UMLS CUI [2,3])
C0005558 (UMLS CUI [2,4])
C0470187 (UMLS CUI [2,5])
C0205394 (UMLS CUI [2,6])
C0040300 (UMLS CUI [2,7])
C1513380 (UMLS CUI [2,8])
Elig.phs000673.v4.p1.7
Item
Older than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1,1])
Elig.phs000673.v4.p1.8
Item
Procedure-specific signed informed consent prior to initiation of any study-related procedures
boolean
C0021430 (UMLS CUI [1,1])
C5421123 (UMLS CUI [1,2])
Elig.phs000673.v4.p1.9
Item
Women and minorities are included in this protocol
boolean
C1512693 (UMLS CUI [1,1])
C0043210 (UMLS CUI [1,2])
C0026192 (UMLS CUI [1,3])
Elig.phs000673.v4.p1.10
Item
Patients with multiple malignancies remain eligible
boolean
C1512693 (UMLS CUI [1,1])
C0346429 (UMLS CUI [1,2])
Elig.phs000673.v4.p1.11
Item
Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible
boolean
C1512693 (UMLS CUI [1,1])
C0019247 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1512693 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0332299 (UMLS CUI [2,3])
C0019247 (UMLS CUI [2,4])
C0006826 (UMLS CUI [2,5])
Elig.phs000673.v4.p1.12
Item
*5.3 Exclusion Criteria: *
boolean
C0680251 (UMLS CUI [1,1])
Elig.phs000673.v4.p1.13
Item
It is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo tissue biopsy
boolean
C0680251 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C1710470 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,4])
C4708589 (UMLS CUI [1,5])
Elig.phs000673.v4.p1.14
Item
Patients who are incarcerated are not eligible to participate
boolean
C0680251 (UMLS CUI [1,1])
C0205255 (UMLS CUI [1,2])
Elig.phs000673.v4.p1.15
Item
Women who are pregnant
boolean
C0680251 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
Elig.phs000673.v4.p1.16
Item
*5.4 Women of childbearing age* For women of childbearing age, there are no screening requirements. We note that most patients entering this study are seeking eligibility for therapy or other clinical trial, in which case they are generally asked to avoiding becoming pregnant and even exercise some form of contraception by their medical oncologist. For women of childbearing age, their referring medical oncologist will discuss necessity or role for appropriate contraception. This is not part of the study activity, nor is it required for participation.
boolean
C3831118 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,4])