ID

30647

Descrição

Overcoming Endocrine Resistance in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02394496

Link

https://clinicaltrials.gov/show/NCT02394496

Palavras-chave

  1. 18/06/2018 18/06/2018 -
  2. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

18 de junho de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT02394496

Eligibility Metastatic Breast Cancer NCT02394496

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
2. histological/cytological confirmation of breast cancer
Descrição

Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678222
3. documented positive hormone receptor status (er+ve and/or pgr+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
Descrição

Estrogen receptor positive tumor | Neoplasm Metastasis Estrogen receptor positive | Progesterone receptor positive tumor | Neoplasm Metastasis Progesterone receptor positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1562312
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0279754
UMLS CUI [3]
C1562928
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0279759
4. postmenopausal women
Descrição

Postmenopausal state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
5. confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
Descrição

Disease Progression | Status post Adjuvant therapy | Status post Therapeutic procedure Neoplasm Metastasis | Aromatase Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0027627
UMLS CUI [4]
C0593802
6. patients demonstrating prior response to ai therapy
Descrição

Aromatase Inhibitors | Disease Response Previous

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205156
7. patients with measurable disease as per recist criteria /patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by recist criteria.
Descrição

Measurable Disease | Osteolytic lesion | Bone lesion Mixed | Bone lesion Sclerotic | Measurable Disease Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0302313
UMLS CUI [3,1]
C0238792
UMLS CUI [3,2]
C0205430
UMLS CUI [4,1]
C0238792
UMLS CUI [4,2]
C0334135
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C0332197
8. may have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
Descrição

Prior radiation therapy Primary tumor | Prior radiation therapy Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0027627
9. life expectancy of at least 8 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
10. who performance status 0, 1 or 2
Descrição

WHO performance status scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1298650
11. patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence.
Descrição

Cancer Other | Disease Free of | Low Risk Recurrence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C3538919
UMLS CUI [3,2]
C2825055
12. are able to swallow and retain oral medication;
Descrição

Able to swallow Oral medication | Ability Retain Oral medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0175795
13. are able to complete all screening assessments as outlined in the protocol;
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
14. patients must have normal organ and marrow function
Descrição

Organ function | Bone Marrow function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
15. left ventricular ejection fraction (lvef) within the institutional normal range
Descrição

Left ventricular ejection fraction Normal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous therapy with fulvestrant and/or lapatinib;
Descrição

fulvestrant | lapatinib

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0935916
UMLS CUI [2]
C1506770
2. patients with her 2 overexpressing, either ihc 3+ or fish +;
Descrição

HER-2 protein overexpression Immunohistochemistry | HER-2 protein overexpression FISH

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3888504
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C3888504
UMLS CUI [2,2]
C0162789
3. concurrent non study anti-cancer therapy (
Descrição

Clinical Trial Cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0920425
4. have unresolved or unstable, serious toxicity from prior administration
Descrição

Toxicity Serious Without Resolution | Toxicity Serious Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C1514893
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0443343
5. have malabsorption syndrome,
Descrição

Malabsorption Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024523
6. have a concurrent disease or condition that would make the patient inappropriate for study participation,
Descrição

Comorbidity Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
7. have an active or uncontrolled infection;
Descrição

Communicable Disease | Communicable Disease Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
8. have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
Descrição

Dementia Informed Consent Excluded | Mental state altered Informed Consent Excluded | Mental condition Informed Consent Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0278060
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0021430
UMLS CUI [2,4]
C0332196
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0021430
UMLS CUI [3,3]
C0332196
9. have a known history of uncontrolled or symptomatic angina, arrhythmias, or chf;
Descrição

Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure Uncontrolled | Symptomatic congestive heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0741212
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0742758
10. receive concurrent treatment with an investigational agent or participate in another clinical trial;
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
11. receive concurrent treatment with prohibited medications
Descrição

Illicit Drugs Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C0087111
12. used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
13. have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.
Descrição

Hypersensitivity Pharmaceutical Preparations Fulvestrant Related | Idiosyncrasy Pharmaceutical Preparations Fulvestrant Related | Hypersensitivity Pharmaceutical Preparations Aromatase Inhibitors Related | Idiosyncrasy Pharmaceutical Preparations Aromatase Inhibitors Related | Hypersensitivity Pharmaceutical Preparations Lapatinib Related | Idiosyncrasy Pharmaceutical Preparations Lapatinib Related | Hypersensitivity Fulvestrant Excipient | Idiosyncrasy Fulvestrant Excipient | Hypersensitivity Aromatase Inhibitors Excipient | Idiosyncrasy Aromatase Inhibitors Excipient | Hypersensitivity Lapatinib Excipient | Idiosyncrasy Lapatinib Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0935916
UMLS CUI [1,4]
C0439849
UMLS CUI [2,1]
C0231191
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0935916
UMLS CUI [2,4]
C0439849
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0593802
UMLS CUI [3,4]
C0439849
UMLS CUI [4,1]
C0231191
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0593802
UMLS CUI [4,4]
C0439849
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C1506770
UMLS CUI [5,4]
C0439849
UMLS CUI [6,1]
C0231191
UMLS CUI [6,2]
C0013227
UMLS CUI [6,3]
C1506770
UMLS CUI [6,4]
C0439849
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0935916
UMLS CUI [7,3]
C0015237
UMLS CUI [8,1]
C0231191
UMLS CUI [8,2]
C0935916
UMLS CUI [8,3]
C0015237
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0593802
UMLS CUI [9,3]
C0015237
UMLS CUI [10,1]
C0231191
UMLS CUI [10,2]
C0593802
UMLS CUI [10,3]
C0015237
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C1506770
UMLS CUI [11,3]
C0015237
UMLS CUI [12,1]
C0231191
UMLS CUI [12,2]
C1506770
UMLS CUI [12,3]
C0015237

Similar models

Eligibility Metastatic Breast Cancer NCT02394496

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma
Item
2. histological/cytological confirmation of breast cancer
boolean
C0678222 (UMLS CUI [1])
Estrogen receptor positive tumor | Neoplasm Metastasis Estrogen receptor positive | Progesterone receptor positive tumor | Neoplasm Metastasis Progesterone receptor positive
Item
3. documented positive hormone receptor status (er+ve and/or pgr+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
boolean
C1562312 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C1562928 (UMLS CUI [3])
C0027627 (UMLS CUI [4,1])
C0279759 (UMLS CUI [4,2])
Postmenopausal state
Item
4. postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Disease Progression | Status post Adjuvant therapy | Status post Therapeutic procedure Neoplasm Metastasis | Aromatase Inhibitors
Item
5. confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C0593802 (UMLS CUI [4])
Aromatase Inhibitors | Disease Response Previous
Item
6. patients demonstrating prior response to ai therapy
boolean
C0593802 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Measurable Disease | Osteolytic lesion | Bone lesion Mixed | Bone lesion Sclerotic | Measurable Disease Absent
Item
7. patients with measurable disease as per recist criteria /patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by recist criteria.
boolean
C1513041 (UMLS CUI [1])
C0302313 (UMLS CUI [2])
C0238792 (UMLS CUI [3,1])
C0205430 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0334135 (UMLS CUI [4,2])
C1513041 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Prior radiation therapy Primary tumor | Prior radiation therapy Neoplasm Metastasis
Item
8. may have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
boolean
C0279134 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Life Expectancy
Item
9. life expectancy of at least 8 months
boolean
C0023671 (UMLS CUI [1])
WHO performance status scale
Item
10. who performance status 0, 1 or 2
boolean
C1298650 (UMLS CUI [1])
Cancer Other | Disease Free of | Low Risk Recurrence
Item
11. patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence.
boolean
C1707251 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C3538919 (UMLS CUI [3,1])
C2825055 (UMLS CUI [3,2])
Able to swallow Oral medication | Ability Retain Oral medication
Item
12. are able to swallow and retain oral medication;
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Protocol Compliance
Item
13. are able to complete all screening assessments as outlined in the protocol;
boolean
C0525058 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
14. patients must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Left ventricular ejection fraction Normal
Item
15. left ventricular ejection fraction (lvef) within the institutional normal range
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
fulvestrant | lapatinib
Item
1. previous therapy with fulvestrant and/or lapatinib;
boolean
C0935916 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
HER-2 protein overexpression Immunohistochemistry | HER-2 protein overexpression FISH
Item
2. patients with her 2 overexpressing, either ihc 3+ or fish +;
boolean
C3888504 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C3888504 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Clinical Trial Cancer treatment
Item
3. concurrent non study anti-cancer therapy (
boolean
C0008976 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Toxicity Serious Without Resolution | Toxicity Serious Unstable
Item
4. have unresolved or unstable, serious toxicity from prior administration
boolean
C0600688 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C1514893 (UMLS CUI [1,4])
C0600688 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Malabsorption Syndrome
Item
5. have malabsorption syndrome,
boolean
C0024523 (UMLS CUI [1])
Comorbidity Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate
Item
6. have a concurrent disease or condition that would make the patient inappropriate for study participation,
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Communicable Disease | Communicable Disease Uncontrolled
Item
7. have an active or uncontrolled infection;
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Dementia Informed Consent Excluded | Mental state altered Informed Consent Excluded | Mental condition Informed Consent Excluded
Item
8. have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
boolean
C0497327 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0278060 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
C3840291 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure Uncontrolled | Symptomatic congestive heart failure
Item
9. have a known history of uncontrolled or symptomatic angina, arrhythmias, or chf;
boolean
C0002962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0741212 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0742758 (UMLS CUI [6])
Study Subject Participation Status | Investigational New Drugs
Item
10. receive concurrent treatment with an investigational agent or participate in another clinical trial;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Illicit Drugs Therapeutic procedure
Item
11. receive concurrent treatment with prohibited medications
boolean
C0086190 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Investigational New Drugs
Item
12. used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Pharmaceutical Preparations Fulvestrant Related | Idiosyncrasy Pharmaceutical Preparations Fulvestrant Related | Hypersensitivity Pharmaceutical Preparations Aromatase Inhibitors Related | Idiosyncrasy Pharmaceutical Preparations Aromatase Inhibitors Related | Hypersensitivity Pharmaceutical Preparations Lapatinib Related | Idiosyncrasy Pharmaceutical Preparations Lapatinib Related | Hypersensitivity Fulvestrant Excipient | Idiosyncrasy Fulvestrant Excipient | Hypersensitivity Aromatase Inhibitors Excipient | Idiosyncrasy Aromatase Inhibitors Excipient | Hypersensitivity Lapatinib Excipient | Idiosyncrasy Lapatinib Excipient
Item
13. have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0935916 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0231191 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0935916 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0593802 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
C0231191 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0593802 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
C0020517 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C1506770 (UMLS CUI [5,3])
C0439849 (UMLS CUI [5,4])
C0231191 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C1506770 (UMLS CUI [6,3])
C0439849 (UMLS CUI [6,4])
C0020517 (UMLS CUI [7,1])
C0935916 (UMLS CUI [7,2])
C0015237 (UMLS CUI [7,3])
C0231191 (UMLS CUI [8,1])
C0935916 (UMLS CUI [8,2])
C0015237 (UMLS CUI [8,3])
C0020517 (UMLS CUI [9,1])
C0593802 (UMLS CUI [9,2])
C0015237 (UMLS CUI [9,3])
C0231191 (UMLS CUI [10,1])
C0593802 (UMLS CUI [10,2])
C0015237 (UMLS CUI [10,3])
C0020517 (UMLS CUI [11,1])
C1506770 (UMLS CUI [11,2])
C0015237 (UMLS CUI [11,3])
C0231191 (UMLS CUI [12,1])
C1506770 (UMLS CUI [12,2])
C0015237 (UMLS CUI [12,3])

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