ID

36570

Beschrijving

A Phase III Trial in NPC With Post-radiation Detectable Plasma EBV DNA; ODM derived from: https://clinicaltrials.gov/show/NCT02363400

Link

https://clinicaltrials.gov/show/NCT02363400

Trefwoorden

Versies (2)
  1. 21-05-19 21-05-19 -
  2. 22-05-19 22-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 mei 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Nasopharyngeal Carcinoma NCT02363400

Engels

Eligibility Nasopharyngeal Carcinoma NCT02363400

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1.histological proven npc.
Beschrijving

Nasopharyngeal carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2931822
2.2010 ajcc stage ii-ivb.
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
3.age ≧ 20 years old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
4.performance status of ecog ≦ 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
5.finished rt ≧ 66 gy (± induction and/or concurrent chemotherapy).
Beschrijving

Therapeutic radiology procedure Completed | Induction Chemotherapy | Induction Chemotherapy Absent | Chemotherapy | Chemotherapy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C3179010
UMLS CUI [3,1]
C3179010
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0392920
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0332197
6.pebv dna > 0 copy/ml at 1±1 week post-rt.
Beschrijving

Epstein-Barr virus DNA Measurement | Status post Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0369169
UMLS CUI [1,2]
C0242485
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1522449
7.re-staging work-ups at 10±2 weeks post-rt showing no active lesions.
Beschrijving

Lesion Absent | Status post Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1522449
8.adequate liver, renal, and bone marrow function 4 weeks before randomization.
Beschrijving

Liver function | Renal function | Bone Marrow function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
9.signed informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pathologically-proven the presence of locoregional disease and/or distant metastasis.
Beschrijving

Disease Locoregional | Distant metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1947913
UMLS CUI [2]
C1269798
2. unequivocally-shown active npc (locoregional/distant) by imaging studies.
Beschrijving

Nasopharyngeal carcinoma Locoregional Imaging study | Nasopharyngeal carcinoma Distant Imaging study

Datatype

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C1947913
UMLS CUI [1,3]
C1881134
UMLS CUI [2,1]
C2931822
UMLS CUI [2,2]
C0443203
UMLS CUI [2,3]
C1881134
3. inadequate rt.
Beschrijving

Therapeutic radiology procedure Inadequate

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205412
4. received any post-rt adjuvant chemotherapy.
Beschrijving

Adjuvant Chemotherapy Post Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1522449
5. pebv dna = 0 copy/ml at 1±1 week post-rt.
Beschrijving

Epstein-Barr virus DNA Measurement | Status post Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0369169
UMLS CUI [1,2]
C0242485
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1522449
6. previous delivery of cisplatin dose > 600 mg/m2.
Beschrijving

Cisplatin Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008838
UMLS CUI [1,2]
C0178602
7. previous delivery of epirubicin > 360 mg/m2.
Beschrijving

Epirubicin Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0014582
UMLS CUI [1,2]
C0178602
8. history of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (dcis) of breast.
Beschrijving

Malignant Neoplasms | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment DCIS

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007124
9. severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
Beschrijving

Disease Cardiopulmonary Severe | Angina, Unstable | Congestive heart failure | Peripheral Vascular Disease Hospitalization Required | COPD exacerbation | Respiration Disorders Hospitalization Required | Mental disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0553534
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0085096
UMLS CUI [4,2]
C1708385
UMLS CUI [5]
C0740304
UMLS CUI [6,1]
C0035204
UMLS CUI [6,2]
C1708385
UMLS CUI [7]
C0004936
10. female patients who are pregnant or lactating.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Terug naar het begin van de pagina

Similar models

Eligibility Nasopharyngeal Carcinoma NCT02363400

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma
Item
1.histological proven npc.
boolean
C2931822 (UMLS CUI [1])
TNM clinical staging
Item
2.2010 ajcc stage ii-ivb.
boolean
C3258246 (UMLS CUI [1])
Age
Item
3.age ≧ 20 years old.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4.performance status of ecog ≦ 2.
boolean
C1520224 (UMLS CUI [1])
Therapeutic radiology procedure Completed | Induction Chemotherapy | Induction Chemotherapy Absent | Chemotherapy | Chemotherapy Absent
Item
5.finished rt ≧ 66 gy (± induction and/or concurrent chemotherapy).
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C3179010 (UMLS CUI [2])
C3179010 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Epstein-Barr virus DNA Measurement | Status post Therapeutic radiology procedure
Item
6.pebv dna > 0 copy/ml at 1±1 week post-rt.
boolean
C0369169 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Lesion Absent | Status post Therapeutic radiology procedure
Item
7.re-staging work-ups at 10±2 weeks post-rt showing no active lesions.
boolean
C0221198 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Liver function | Renal function | Bone Marrow function
Item
8.adequate liver, renal, and bone marrow function 4 weeks before randomization.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Informed Consent
Item
9.signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Locoregional | Distant metastasis
Item
1. pathologically-proven the presence of locoregional disease and/or distant metastasis.
boolean
C0012634 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2])
Nasopharyngeal carcinoma Locoregional Imaging study | Nasopharyngeal carcinoma Distant Imaging study
Item
2. unequivocally-shown active npc (locoregional/distant) by imaging studies.
boolean
C2931822 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C1881134 (UMLS CUI [1,3])
C2931822 (UMLS CUI [2,1])
C0443203 (UMLS CUI [2,2])
C1881134 (UMLS CUI [2,3])
Therapeutic radiology procedure Inadequate
Item
3. inadequate rt.
boolean
C1522449 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Adjuvant Chemotherapy Post Therapeutic radiology procedure
Item
4. received any post-rt adjuvant chemotherapy.
boolean
C0085533 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
Epstein-Barr virus DNA Measurement | Status post Therapeutic radiology procedure
Item
5. pebv dna = 0 copy/ml at 1±1 week post-rt.
boolean
C0369169 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Cisplatin Dose
Item
6. previous delivery of cisplatin dose > 600 mg/m2.
boolean
C0008838 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Epirubicin Dose
Item
7. previous delivery of epirubicin > 360 mg/m2.
boolean
C0014582 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment DCIS
Item
8. history of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (dcis) of breast.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007124 (UMLS CUI [4,3])
Disease Cardiopulmonary Severe | Angina, Unstable | Congestive heart failure | Peripheral Vascular Disease Hospitalization Required | COPD exacerbation | Respiration Disorders Hospitalization Required | Mental disorders
Item
9. severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
boolean
C0012634 (UMLS CUI [1,1])
C0553534 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0085096 (UMLS CUI [4,1])
C1708385 (UMLS CUI [4,2])
C0740304 (UMLS CUI [5])
C0035204 (UMLS CUI [6,1])
C1708385 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
10. female patients who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial