ID

41192

Beskrivning

Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02115464

Länk

https://clinicaltrials.gov/show/NCT02115464

Nyckelord

Versioner (1)
  1. 10/07/2020 10/07/2020 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 juillet 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT02115464

Engelsk

Eligibility Lung Cancer NCT02115464

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age >/=18 to </= 80 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. unresected and pathologically (histologic) proven stage 3a or stage 3b nsclc of adenocarcinoma, squamous cell, large cell or mixed histology, diagnosed within three months of study randomization.
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging Unresected | Non-Small Cell Adenocarcinoma | Squamous non-small cell lung cancer | Carcinoma, Large Cell

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C2986425
UMLS CUI [2]
C1335060
UMLS CUI [3]
C4509816
UMLS CUI [4]
C0206704
3. non-metastatic disease staged by: physical examination, ct-chest and upper abdomen, brain mri or contrast-enhanced ct and whole body fluorodeoxyglucose (fdg)-pet/ct scan within two months of study randomization.
Beskrivning

Disease Nonmetastatic Staging | Physical Examination | Chest CT | CT of upper abdomen | Nuclear magnetic resonance imaging brain | CT with Contrast | Whole body PET with CT with F-FDG

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518409
UMLS CUI [1,3]
C0332305
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0202823
UMLS CUI [4]
C1627748
UMLS CUI [5]
C4028269
UMLS CUI [6]
C0742919
UMLS CUI [7]
C4271885
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. eastern cooperative oncology group (ecog) performance status >2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
2. more than 10% weight loss in the past 3 months.
Beskrivning

Weight loss Percentage Timespan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
3. diabetic patient or anyone currently taking metformin, insulin or other anti-hyperglycemic therapy.
Beskrivning

Patient Diabetic | metformin | Insulin | Hypoglycemic Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0241863
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0021641
UMLS CUI [4]
C0020616
4. pulmonary function test (pfts) (within the last 12 weeks) with forced expiratory volume (fev)1 < 1.2 litres per second or less than 50% of predicted.
Beskrivning

Pulmonary function tests | FEV1 | Percent predicted FEV1

Datatyp

boolean

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2]
C0849974
UMLS CUI [3]
C0730561
5. complete blood count (cbc) and biochemical renal and liver function profiles that do not permit chemotherapy treatment (as per institutional standard of care).
Beskrivning

Complete Blood Count | Renal function Chemistry profile | Liver function Chemistry profile | Chemotherapy Absence Required

Datatyp

boolean

Alias
UMLS CUI [1]
C0009555
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0545265
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0545265
UMLS CUI [4,1]
C3665472
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C1514873
6. fasting blood sugar levels of >/= 7.0 mmol per litre.
Beskrivning

Fasting blood glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0428568
7. prior systemic chemotherapy for lung cancer.
Beskrivning

Systemic Chemotherapy Malignant neoplasm of lung

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0242379
8. prior radiotherapy that would overlap with the planned treatment area.
Beskrivning

Prior Radiation Therapy | Overlap Treatment Area

Datatyp

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C1948020
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205146
9. prior invasive malignancy within the past 3 years (except non-melanomatous skin cancer non-invasive carcinoma in-situ of the breast, oral cavity or cervix).
Beskrivning

Invasive Malignant Neoplasm | Exception Skin carcinoma | Exception Carcinoma in situ of female breast Non-invasive | Exception Oral cavity | Exception Malignant tumor of cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0686288
UMLS CUI [3,3]
C0205303
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0226896
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007847
10. known acquired immune deficiency syndrome (aids).
Beskrivning

AIDS

Datatyp

boolean

Alias
UMLS CUI [1]
C0001175
11. patients with increased risk for lactic acidosis:
Beskrivning

High risk Lactic Acidosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C0001125
severe congestive heart failure (nyha: class iii or iv),
Beskrivning

Congestive heart failure Severe New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
history of metabolic acidosis,
Beskrivning

Metabolic acidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0220981
alcoholic intake of > 3 drinks daily,
Beskrivning

Alcohol consumption Drinks per day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0439505
severe liver disease,
Beskrivning

Liver disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
renal failure
Beskrivning

Kidney Failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0035078
12. known hypersensitivity or allergy to metformin.
Beskrivning

Allergy to metformin

Datatyp

boolean

Alias
UMLS CUI [1]
C0571648
13. known pregnancy or lactating female patient.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
14. geographic inaccessibility for follow-up.
Beskrivning

Patient Unavailable Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0686905
UMLS CUI [1,3]
C3274571
15. inability to provide informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

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

Eligibility Lung Cancer NCT02115464

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age >/=18 to </= 80 years of age.
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging Unresected | Non-Small Cell Adenocarcinoma | Squamous non-small cell lung cancer | Carcinoma, Large Cell
Item
2. unresected and pathologically (histologic) proven stage 3a or stage 3b nsclc of adenocarcinoma, squamous cell, large cell or mixed histology, diagnosed within three months of study randomization.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C2986425 (UMLS CUI [1,3])
C1335060 (UMLS CUI [2])
C4509816 (UMLS CUI [3])
C0206704 (UMLS CUI [4])
Disease Nonmetastatic Staging | Physical Examination | Chest CT | CT of upper abdomen | Nuclear magnetic resonance imaging brain | CT with Contrast | Whole body PET with CT with F-FDG
Item
3. non-metastatic disease staged by: physical examination, ct-chest and upper abdomen, brain mri or contrast-enhanced ct and whole body fluorodeoxyglucose (fdg)-pet/ct scan within two months of study randomization.
boolean
C0012634 (UMLS CUI [1,1])
C1518409 (UMLS CUI [1,2])
C0332305 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C0202823 (UMLS CUI [3])
C1627748 (UMLS CUI [4])
C4028269 (UMLS CUI [5])
C0742919 (UMLS CUI [6])
C4271885 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
ECOG performance status
Item
1. eastern cooperative oncology group (ecog) performance status >2.
boolean
C1520224 (UMLS CUI [1])
Weight loss Percentage Timespan
Item
2. more than 10% weight loss in the past 3 months.
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Patient Diabetic | metformin | Insulin | Hypoglycemic Agents
Item
3. diabetic patient or anyone currently taking metformin, insulin or other anti-hyperglycemic therapy.
boolean
C0030705 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
C0020616 (UMLS CUI [4])
Pulmonary function tests | FEV1 | Percent predicted FEV1
Item
4. pulmonary function test (pfts) (within the last 12 weeks) with forced expiratory volume (fev)1 < 1.2 litres per second or less than 50% of predicted.
boolean
C0024119 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
C0730561 (UMLS CUI [3])
Complete Blood Count | Renal function Chemistry profile | Liver function Chemistry profile | Chemotherapy Absence Required
Item
5. complete blood count (cbc) and biochemical renal and liver function profiles that do not permit chemotherapy treatment (as per institutional standard of care).
boolean
C0009555 (UMLS CUI [1])
C0232804 (UMLS CUI [2,1])
C0545265 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0545265 (UMLS CUI [3,2])
C3665472 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
Fasting blood glucose measurement
Item
6. fasting blood sugar levels of >/= 7.0 mmol per litre.
boolean
C0428568 (UMLS CUI [1])
Systemic Chemotherapy Malignant neoplasm of lung
Item
7. prior systemic chemotherapy for lung cancer.
boolean
C1883256 (UMLS CUI [1,1])
C0242379 (UMLS CUI [1,2])
Prior Radiation Therapy | Overlap Treatment Area
Item
8. prior radiotherapy that would overlap with the planned treatment area.
boolean
C0279134 (UMLS CUI [1])
C1948020 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205146 (UMLS CUI [2,3])
Invasive Malignant Neoplasm | Exception Skin carcinoma | Exception Carcinoma in situ of female breast Non-invasive | Exception Oral cavity | Exception Malignant tumor of cervix
Item
9. prior invasive malignancy within the past 3 years (except non-melanomatous skin cancer non-invasive carcinoma in-situ of the breast, oral cavity or cervix).
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0686288 (UMLS CUI [3,2])
C0205303 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0226896 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007847 (UMLS CUI [5,2])
AIDS
Item
10. known acquired immune deficiency syndrome (aids).
boolean
C0001175 (UMLS CUI [1])
High risk Lactic Acidosis
Item
11. patients with increased risk for lactic acidosis:
boolean
C4319571 (UMLS CUI [1,1])
C0001125 (UMLS CUI [1,2])
Congestive heart failure Severe New York Heart Association Classification
Item
severe congestive heart failure (nyha: class iii or iv),
boolean
C0018802 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Metabolic acidosis
Item
history of metabolic acidosis,
boolean
C0220981 (UMLS CUI [1])
Alcohol consumption Drinks per day
Item
alcoholic intake of > 3 drinks daily,
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
Liver disease Severe
Item
severe liver disease,
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Kidney Failure
Item
renal failure
boolean
C0035078 (UMLS CUI [1])
Allergy to metformin
Item
12. known hypersensitivity or allergy to metformin.
boolean
C0571648 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
13. known pregnancy or lactating female patient.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Patient Unavailable Follow-up
Item
14. geographic inaccessibility for follow-up.
boolean
C0030705 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Informed Consent Unable
Item
15. inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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