Englisch

Eligibility Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck (SCCHN) NCT02207530

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent obtained from the patient/legal representative;
Beschreibung

Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
histologically confirmed recurrent or metastatic scchn;
Beschreibung

Recurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C4524839
UMLS CUI [2]
C0744620
confirmed pd-l1-positive scchn by a specified ihc assay;
Beschreibung

Squamous cell carcinoma of the head and neck PD-L1 Positive Immunohistochemistry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C4284303
UMLS CUI [1,3]
C0021044
tumor progression or recurrence during or after treatment with one systemic regimen for recurrent or metastatic disease that must have contained a platinum agent;
Beschreibung

Tumor Progression | Recurrent tumor | Systemic therapy Containing Platinum | Recurrent disease | Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0178874
UMLS CUI [2]
C0521158
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0032207
UMLS CUI [4]
C0277556
UMLS CUI [5]
C0027627
who performance status of 0 or 1;
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
at least 1 measurable lesion at baseline
Beschreibung

Measurable lesion Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any concurrent chemotherapy, ip, biologic, or hormonal therapy for cancer treatment;
Beschreibung

Chemotherapy | Therapies, Investigational | Biological treatment | Hormone Therapy | Cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0949266
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0920425
major surgical procedure within 28 days prior to the first dose of ip;
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
non-squamous histologies;
Beschreibung

Non-squamous cell Histology

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1545484
UMLS CUI [1,2]
C0344441
history of active primary immunodeficiency;
Beschreibung

Primary immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0398686
active or prior documented autoimmune or inflammatory disorders
Beschreibung

Autoimmune Disease | Inflammatory disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C1290884
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Ähnliche Modelle

Eligibility Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck (SCCHN) NCT02207530

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
written informed consent obtained from the patient/legal representative;
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Recurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell Carcinoma
Item
histologically confirmed recurrent or metastatic scchn;
boolean
C4524839 (UMLS CUI [1])
C0744620 (UMLS CUI [2])
Squamous cell carcinoma of the head and neck PD-L1 Positive Immunohistochemistry
Item
confirmed pd-l1-positive scchn by a specified ihc assay;
boolean
C1168401 (UMLS CUI [1,1])
C4284303 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
Tumor Progression | Recurrent tumor | Systemic therapy Containing Platinum | Recurrent disease | Neoplasm Metastasis
Item
tumor progression or recurrence during or after treatment with one systemic regimen for recurrent or metastatic disease that must have contained a platinum agent;
boolean
C0178874 (UMLS CUI [1])
C0521158 (UMLS CUI [2])
C1515119 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0032207 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4])
C0027627 (UMLS CUI [5])
WHO performance status scale
Item
who performance status of 0 or 1;
boolean
C1298650 (UMLS CUI [1])
Measurable lesion Quantity
Item
at least 1 measurable lesion at baseline
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapies, Investigational | Biological treatment | Hormone Therapy | Cancer treatment
Item
any concurrent chemotherapy, ip, biologic, or hormonal therapy for cancer treatment;
boolean
C0392920 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0920425 (UMLS CUI [5])
Major surgery
Item
major surgical procedure within 28 days prior to the first dose of ip;
boolean
C0679637 (UMLS CUI [1])
Non-squamous cell Histology
Item
non-squamous histologies;
boolean
C1545484 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
Primary immunodeficiency
Item
history of active primary immunodeficiency;
boolean
C0398686 (UMLS CUI [1])
Autoimmune Disease | Inflammatory disorder
Item
active or prior documented autoimmune or inflammatory disorders
boolean
C0004364 (UMLS CUI [1])
C1290884 (UMLS CUI [2])
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