ID

15661

Description

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

Lien

https://clinicaltrials.gov/show/NCT02274038

Mots-clés

Versions (1)
  1. 07/06/2016 07/06/2016 -
Téléchargé le

7 juin 2016

DOI

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Licence

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

Anglais

Eligibility Non-small Cell Lung Cancer NCT02274038

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age | Adult

Type de données

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)
Description

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

Type de données

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.
Description

systemic therapy | pemetrexed | Platinum-based Drug

Type de données

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.
Description

Informed consent

Type de données

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.
Description

Compliance behavior Study Protocol

Type de données

boolean

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

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.
Description

Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test

Type de données

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.
Description

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

Type de données

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.
Description

Chemotherapy Regimen

Type de données

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.
Description

cancer surgery | Part of Disease Removed

Type de données

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
Description

Diagnostic Imaging Unable

Type de données

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.
Description

medical condition Affecting patient safety | Study Subject Participation Status Limited

Type de données

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
Description

Informed Consent Unable

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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