ID

15669

Beskrivning

Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects; ODM derived from: https://clinicaltrials.gov/show/NCT02284139

Länk

https://clinicaltrials.gov/show/NCT02284139

Nyckelord

Versioner (1)
  1. 2016-06-07 2016-06-07 -
Uppladdad den

7 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02284139

Engelsk

Eligibility Non-small Cell Lung Cancer NCT02284139

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age: older than 20
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. eastern cooperative oncology group (ecog) performance status 0 -2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
3. histologically confirmed lung cancer, pancreatic cancer, or colon cancer
Beskrivning

Malignant neoplasm of lung | Pancreatic carcinoma | Malignant tumor of colon

Datatyp

boolean

Alias
UMLS CUI [1]
C0242379
UMLS CUI [2]
C0235974
UMLS CUI [3]
C0007102
4. patients take egfr inhibitor following the reason
Beskrivning

Epidermal growth factor receptor inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C1443775
egfr mutation (+) nsclc - adenocarcinoma for 1st line treatment
Beskrivning

EGFR gene mutation Non-Small Cell Lung Carcinoma | Adenocarcinoma First line treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C0001418
UMLS CUI [2,2]
C1708063
nsclc - for ≥ 2nd line treatment
Beskrivning

Non-Small Cell Lung Carcinoma | Second line treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C1710038
pancreatic cancer - adenocarcinoma for 1st line treatment with gemcitabine
Beskrivning

Pancreatic carcinoma | Adenocarcinoma First line treatment gemcitabine

Datatyp

boolean

Alias
UMLS CUI [1]
C0235974
UMLS CUI [2,1]
C0001418
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0045093
colon cancer - adenocarcinoma 1st line treatment with irinotecan (folfiri)
Beskrivning

Malignant tumor of colon | Adenocarcinoma First line treatment irinotecan Folinic Acid-Fluorouracil-Irinotecan Regimen

Datatyp

boolean

Alias
UMLS CUI [1]
C0007102
UMLS CUI [2,1]
C0001418
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0123931
UMLS CUI [2,4]
C1880658
5. patients who have egfr inhibitor related skin side effects (erse) gr≥2 (ncictc v4.0)
Beskrivning

Skin side effects Due to Epidermal growth factor receptor inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C0879626
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1443775
6. a patient with the willingness to comply with the study protocol during the study period and capable of complying with it
Beskrivning

Compliance behavior Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
7. a patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
Beskrivning

Informed consent | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2348568
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a patient with previous active or passive immunotherapy
Beskrivning

Prior Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514461
2. a pregnant or lactating patient
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. a patient of childbearing potential without being tested for pregnancy at baseline for positive. (a postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
Beskrivning

Childbearing Potential | Pregnancy test positive Absent | Postmenopausal state | Amenorrhea Period

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0240802
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0002453
UMLS CUI [4,2]
C1948053
4. a patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
Beskrivning

Seizures Uncontrolled | CNS disorder | Mental disorders | Informed Consent Unable | Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0007682
UMLS CUI [3]
C0004936
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C1299582
UMLS CUI [5,1]
C1321605
UMLS CUI [5,2]
C0439801
5. a patient with history of dermatologic care (except transient urticaria) within 4 weeks
Beskrivning

Care Dermatologic | Urticaria Transient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1947933
UMLS CUI [1,2]
C0205489
UMLS CUI [2,1]
C0042109
UMLS CUI [2,2]
C0205374
6. a patient with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months
Beskrivning

Heart Diseases | Congestive heart failure | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0027051
7. a patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
Beskrivning

Pneumonia, Interstitial | Pulmonary Fibrosis Diffused Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2,1]
C0034069
UMLS CUI [2,2]
C0012222
UMLS CUI [2,3]
C0231220
8. organ allogenic transplantation requiring immunosuppressive therapy. any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by case basis prior to enrolling the subject
Beskrivning

Transplantation, Homologous | Therapeutic immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1]
C0040739
UMLS CUI [2]
C0021079
9. known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
Beskrivning

Hypersensitivity Investigational New Drugs | intolerance to Investigational New Drugs | Hypersensitivity Chemotherapy Pharmaceutical Preparations | intolerance to Chemotherapy Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C0013227
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C0013227
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02284139

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age: older than 20
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. eastern cooperative oncology group (ecog) performance status 0 -2
boolean
C1520224 (UMLS CUI [1])
Malignant neoplasm of lung | Pancreatic carcinoma | Malignant tumor of colon
Item
3. histologically confirmed lung cancer, pancreatic cancer, or colon cancer
boolean
C0242379 (UMLS CUI [1])
C0235974 (UMLS CUI [2])
C0007102 (UMLS CUI [3])
Epidermal growth factor receptor inhibitor
Item
4. patients take egfr inhibitor following the reason
boolean
C1443775 (UMLS CUI [1])
EGFR gene mutation Non-Small Cell Lung Carcinoma | Adenocarcinoma First line treatment
Item
egfr mutation (+) nsclc - adenocarcinoma for 1st line treatment
boolean
C3266992 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0001418 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
Non-Small Cell Lung Carcinoma | Second line treatment
Item
nsclc - for ≥ 2nd line treatment
boolean
C0007131 (UMLS CUI [1])
C1710038 (UMLS CUI [2])
Pancreatic carcinoma | Adenocarcinoma First line treatment gemcitabine
Item
pancreatic cancer - adenocarcinoma for 1st line treatment with gemcitabine
boolean
C0235974 (UMLS CUI [1])
C0001418 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0045093 (UMLS CUI [2,3])
Malignant tumor of colon | Adenocarcinoma First line treatment irinotecan Folinic Acid-Fluorouracil-Irinotecan Regimen
Item
colon cancer - adenocarcinoma 1st line treatment with irinotecan (folfiri)
boolean
C0007102 (UMLS CUI [1])
C0001418 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0123931 (UMLS CUI [2,3])
C1880658 (UMLS CUI [2,4])
Skin side effects Due to Epidermal growth factor receptor inhibitor
Item
5. patients who have egfr inhibitor related skin side effects (erse) gr≥2 (ncictc v4.0)
boolean
C1123023 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1443775 (UMLS CUI [1,4])
Compliance behavior Study Protocol
Item
6. a patient with the willingness to comply with the study protocol during the study period and capable of complying with it
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed consent | Study Subject Participation Status
Item
7. a patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
boolean
C0021430 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior Immunotherapy
Item
1. a patient with previous active or passive immunotherapy
boolean
C1514461 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
2. a pregnant or lactating patient
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential | Pregnancy test positive Absent | Postmenopausal state | Amenorrhea Period
Item
3. a patient of childbearing potential without being tested for pregnancy at baseline for positive. (a postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
boolean
C3831118 (UMLS CUI [1])
C0240802 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0002453 (UMLS CUI [4,1])
C1948053 (UMLS CUI [4,2])
Seizures Uncontrolled | CNS disorder | Mental disorders | Informed Consent Unable | Compliance behavior Limited
Item
4. a patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007682 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
C1321605 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
Care Dermatologic | Urticaria Transient
Item
5. a patient with history of dermatologic care (except transient urticaria) within 4 weeks
boolean
C1947933 (UMLS CUI [1,1])
C0205489 (UMLS CUI [1,2])
C0042109 (UMLS CUI [2,1])
C0205374 (UMLS CUI [2,2])
Heart Diseases | Congestive heart failure | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia | Myocardial Infarction
Item
6. a patient with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Pneumonia, Interstitial | Pulmonary Fibrosis Diffused Symptomatic
Item
7. a patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2,1])
C0012222 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
Transplantation, Homologous | Therapeutic immunosuppression
Item
8. organ allogenic transplantation requiring immunosuppressive therapy. any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by case basis prior to enrolling the subject
boolean
C0040739 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | intolerance to Investigational New Drugs | Hypersensitivity Chemotherapy Pharmaceutical Preparations | intolerance to Chemotherapy Pharmaceutical Preparations
Item
9. known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
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