ID

15661

Descripción

Serial [18F]Thymidine (FLT)PET/CT as a Biomarker of Response in Pemetrexed Therapy for Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02274038

Link

https://clinicaltrials.gov/show/NCT02274038

Palabras clave

Versiones (1)
  1. 7/6/16 7/6/16 -
Subido en

7 de junio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02274038

Inglés

Eligibility Non-small Cell Lung Cancer NCT02274038

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult patients, at least 18 years of age
Descripción

Age | Adult

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0001675
2. histologically confirmed non-small cell lung cancer with at least one site of disease > 1 cm by at least one type of standard imaging (e.g. ct, chest x-ray, mri)
Descripción

Non-Small Cell Lung Carcinoma | Site Disease | Diagnostic Imaging | X-Ray Computed Tomography | Plain chest X-ray | Magnetic Resonance Imaging

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0012634
UMLS CUI [3]
C0011923
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0039985
UMLS CUI [6]
C0024485
3. recommmended to start systemic therapy which includes pemetrexed and a platinum-based agent.
Descripción

systemic therapy | pemetrexed | Platinum-based Drug

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2]
C0210657
UMLS CUI [3]
C2266918
4. participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
5. participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician.
Descripción

Compliance behavior Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430056
2. patients with only a single site of primary lung cancer who have undergone or are recommended to undergo radiation therapy to that site will not be eligible, the inclusion of patients who may be undergoing radiation therapy to ancillary disease sites may be allowed to enter the study at the discretion of the pi if it is not felt to affect the ability to capture flt information for at least one primary site of disease.
Descripción

Carcinoma of lung Primary | Site Single | Therapeutic radiology procedure | FLT-Positron Emission Tomography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0684249
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0205171
UMLS CUI [3]
C1522449
UMLS CUI [4]
C3641248
3. patients who have received chemotherapy within 2 weeks of enrollment will be excluded from the study.
Descripción

Chemotherapy Regimen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
4. patients who have undergone cancer surgery removing a significant portion of active disease, in the opinion of an investigator, within 2 months prior to study enrollment will be excluded.
Descripción

cancer surgery | Part of Disease Removed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920424
UMLS CUI [2,1]
C1292711
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0849355
5. inability to tolerate imaging procedures in the opinion of the investigator or treating physician
Descripción

Diagnostic Imaging Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1299582
6. serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
Descripción

medical condition Affecting patient safety | Study Subject Participation Status Limited

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0439801
7. unwilling or unable to provide informed consent
Descripción

Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02274038

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Adult
Item
1. adult patients, at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma | Site Disease | Diagnostic Imaging | X-Ray Computed Tomography | Plain chest X-ray | Magnetic Resonance Imaging
Item
2. histologically confirmed non-small cell lung cancer with at least one site of disease > 1 cm by at least one type of standard imaging (e.g. ct, chest x-ray, mri)
boolean
C0007131 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0011923 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0039985 (UMLS CUI [5])
C0024485 (UMLS CUI [6])
systemic therapy | pemetrexed | Platinum-based Drug
Item
3. recommmended to start systemic therapy which includes pemetrexed and a platinum-based agent.
boolean
C1515119 (UMLS CUI [1])
C0210657 (UMLS CUI [2])
C2266918 (UMLS CUI [3])
Informed consent
Item
4. participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Study Protocol
Item
5. participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician.
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test
Item
1. females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
Carcinoma of lung Primary | Site Single | Therapeutic radiology procedure | FLT-Positron Emission Tomography
Item
2. patients with only a single site of primary lung cancer who have undergone or are recommended to undergo radiation therapy to that site will not be eligible, the inclusion of patients who may be undergoing radiation therapy to ancillary disease sites may be allowed to enter the study at the discretion of the pi if it is not felt to affect the ability to capture flt information for at least one primary site of disease.
boolean
C0684249 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3])
C3641248 (UMLS CUI [4])
Chemotherapy Regimen
Item
3. patients who have received chemotherapy within 2 weeks of enrollment will be excluded from the study.
boolean
C0392920 (UMLS CUI [1])
cancer surgery | Part of Disease Removed
Item
4. patients who have undergone cancer surgery removing a significant portion of active disease, in the opinion of an investigator, within 2 months prior to study enrollment will be excluded.
boolean
C0920424 (UMLS CUI [1])
C1292711 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0849355 (UMLS CUI [2,3])
Diagnostic Imaging Unable
Item
5. inability to tolerate imaging procedures in the opinion of the investigator or treating physician
boolean
C0011923 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
medical condition Affecting patient safety | Study Subject Participation Status Limited
Item
6. serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
boolean
C1699700 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Informed Consent Unable
Item
7. unwilling or unable to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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