ID

27372

Beskrivning

Early Prediction of Therapeutic Response to Targeted Therapy in Stage IIIB/IV or Recurrent Lung Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00708448

Länk

https://clinicaltrials.gov/show/NCT00708448

Nyckelord

Versioner (1)
  1. 2017-11-09 2017-11-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 november 2017

DOI

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Creative Commons BY 4.0
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Eligibility Cancer NCT00708448

Engelsk

Eligibility Cancer NCT00708448

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00708448
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all subjects must be enrolled in the the therapeutic trial (irb # 24377) with non-squamous non-small cell lung cancer (nsclc) treated with combined erlotinib (tarceva) (150 mg/day)and bevacizumab (avastin) (15mg/kg q 21 days) as first line therapy.
Beskrivning

First line treatment Nonsquamous nonsmall cell neoplasm of lung | erlotinib U/day | Tarceva; U/day | bevacizumab | Avastin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C2585890
UMLS CUI [2,1]
C1135135
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C1135136
UMLS CUI [3,2]
C0456683
UMLS CUI [4]
C0796392
UMLS CUI [5]
C1135130
2. adults must have radiological evidence of stage iiib/iv or recurrent non-squamous non-small cell carcinoma. the stage iiib/iv or recurrent lesion must be in a location that includes a large arterial vessel to allow for determination of the h215o arterial input function. a previous histological diagnosis of nsclc would be required prior to institution of therapy. only clinically indicated biopsy and/or surgery for determination of stage iiib/iv or recurrent disease will be done and surgery is incidental to inclusion in the protocol.
Beskrivning

Adult | Nonsquamous nonsmall cell neoplasm of lung TNM clinical staging Radiology | Nonsquamous nonsmall cell neoplasm of lung Recurrent Radiology | Other Coding | Indication Biopsy | Indication Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C2585890
UMLS CUI [2,2]
C3258246
UMLS CUI [2,3]
C0043299
UMLS CUI [3,1]
C2585890
UMLS CUI [3,2]
C2945760
UMLS CUI [3,3]
C0043299
UMLS CUI [4]
C3846158
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0005558
UMLS CUI [6,1]
C3146298
UMLS CUI [6,2]
C0543467
3. patients must be 18 years or older for inclusion in this study. since there is no experience with [f-18]flt in children and it would be inappropriate to study individuals under the age of 18 until more safety data is available.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. after entry into the study, patients are expected to be followed for at least 2 months as part of standard of care.
Beskrivning

Standard of Care

Datatyp

boolean

Alias
UMLS CUI [1]
C2936643
5. all patients, or their legal guardians, must sign a written informed consent and hipaa authorization in accordance with institutional guidelines.
Beskrivning

Informed Consent | Informed Consent Legal Guardians

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
6. the patient, if female, must be postmenopausal for a minimum of one year or surgically sterile, or on one of the following methods of birth control for a minimum of one month prior to entry into this study: iud, oral contraceptives, depo-provera or norplant. these criteria can be waived at the discretion of the investigator if the patient's tumor is considered life threatening and the one month wait required is not in the best interest of the patient. negative pregnancy test is accepted.
Beskrivning

Postmenopausal state | Female Sterilization | Contraceptive methods | Intrauterine Devices | Contraceptives, Oral | Depo-Provera | Norplant | Pregnancy test negative Accepted

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0700589
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0009905
UMLS CUI [6]
C0699700
UMLS CUI [7]
C1145675
UMLS CUI [8,1]
C0427780
UMLS CUI [8,2]
C1272684
7. pre-treatment laboratory tests for patients receiving [f-18]flt must be performed within 21 days prior to study entry. these must be less than 4 times below or above the upper or lower limit range for the respective laboratory test. the patients have stage iiib/iv or recurrent nsclc and therefore many routine laboratory tests may not be within the typical normal range. using a factor of 4 times above or below the upper or lower value for the normal range for laboratory test will assure ability to recruit patients and maintain safety. in those instances where a value of 4x above the normal range would be inappropriate for inclusion (prothrombin time and partial thromboplastin time) then a value of 2.5x will be used for these two laboratory tests. in those instances when the prothrombin time or partial thromboplastin time are greater than 2.5x the upper limit of normal then such a patient would not be enrolled. the 4x value will be used for all laboratory values except prothrombin time and partial thromboplastin time which cannot be above or below 2.5 times the upper or lower limit of normal (appendix e, [f-18]flt laboratory study results). a negative serum pregnancy test is required within 2 days prior to the pet studies.
Beskrivning

Laboratory Procedures pre treatment | 18F-FLT | Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Serum pregnancy test negative | PET scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2709094
UMLS CUI [2]
C1432709
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C3258246
UMLS CUI [4]
C0278517
UMLS CUI [5]
C0033707
UMLS CUI [6]
C0030605
UMLS CUI [7]
C0430061
UMLS CUI [8]
C0032743
8. pre-treatment radiological clinical scans/studies (gd- enhanced mri or ct to document stage iiib/iv or recurrent nsclc) must be performed within 30 days of study entry.
Beskrivning

Radiology pre treatment | Non-Small Cell Lung Carcinoma TNM clinical staging MRI gadolinium-enhanced | Non-small cell lung cancer recurrent CT | Non-Small Cell Lung Carcinoma TNM clinical staging CT | Non-small cell lung cancer recurrent MRI gadolinium-enhanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043299
UMLS CUI [1,2]
C2709094
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
UMLS CUI [2,3]
C0855566
UMLS CUI [3,1]
C0278517
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C0007131
UMLS CUI [4,2]
C3258246
UMLS CUI [4,3]
C0040405
UMLS CUI [5,1]
C0278517
UMLS CUI [5,2]
C0855566
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients will be receiving erlotinib (tarceva) (150 mg/day)and bevacizumab (avastin) (15mg/kg q 21 days) as part of the therapeutic trial. enrollment may not occur if the patient does not meet the enrollment criteria for the therapeutic trial
Beskrivning

Inclusion criteria Mismatch | erlotinib U/day | Tarceva U/day | bevacizumab | Avastin | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1881865
UMLS CUI [2,1]
C1135135
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C1135136
UMLS CUI [3,2]
C0456683
UMLS CUI [4]
C0796392
UMLS CUI [5]
C1135130
UMLS CUI [6]
C0949266
2. patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. patients with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion.
Beskrivning

Hypersensitivity Radiopharmaceuticals | Drug Allergy allowed | Hypersensitivity allowed | Autoimmune Diseases allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0182638
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0004364
UMLS CUI [4,2]
C0683607
3. patients who are pregnant or lactating or who suspect they might be pregnant.
Beskrivning

Pregnancy | Breast Feeding | Possible pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0425965
4. adult patients who require monitored anesthesia for pet scanning.
Beskrivning

Adult | Monitored anesthesia PET scan

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0497677
UMLS CUI [2,2]
C0032743
5. hiv positive patients due to the previous toxicity noted with flt.
Beskrivning

HIV Seropositivity Due to 18F-FLT Toxicity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1432709
UMLS CUI [1,4]
C0600688
6. claustrophobia or inability to remain stationary within the pet scanner for 90 minutes.
Beskrivning

Claustrophobia | Hospital Stay PET unit Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2,1]
C3489408
UMLS CUI [2,2]
C0182349
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Cancer NCT00708448

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT00708448
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
First line treatment Nonsquamous nonsmall cell neoplasm of lung | erlotinib U/day | Tarceva; U/day | bevacizumab | Avastin
Item
1. all subjects must be enrolled in the the therapeutic trial (irb # 24377) with non-squamous non-small cell lung cancer (nsclc) treated with combined erlotinib (tarceva) (150 mg/day)and bevacizumab (avastin) (15mg/kg q 21 days) as first line therapy.
boolean
C1708063 (UMLS CUI [1,1])
C2585890 (UMLS CUI [1,2])
C1135135 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C1135136 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0796392 (UMLS CUI [4])
C1135130 (UMLS CUI [5])
Adult | Nonsquamous nonsmall cell neoplasm of lung TNM clinical staging Radiology | Nonsquamous nonsmall cell neoplasm of lung Recurrent Radiology | Other Coding | Indication Biopsy | Indication Operative Surgical Procedures
Item
2. adults must have radiological evidence of stage iiib/iv or recurrent non-squamous non-small cell carcinoma. the stage iiib/iv or recurrent lesion must be in a location that includes a large arterial vessel to allow for determination of the h215o arterial input function. a previous histological diagnosis of nsclc would be required prior to institution of therapy. only clinically indicated biopsy and/or surgery for determination of stage iiib/iv or recurrent disease will be done and surgery is incidental to inclusion in the protocol.
boolean
C0001675 (UMLS CUI [1])
C2585890 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0043299 (UMLS CUI [2,3])
C2585890 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
C0043299 (UMLS CUI [3,3])
C3846158 (UMLS CUI [4])
C3146298 (UMLS CUI [5,1])
C0005558 (UMLS CUI [5,2])
C3146298 (UMLS CUI [6,1])
C0543467 (UMLS CUI [6,2])
Age
Item
3. patients must be 18 years or older for inclusion in this study. since there is no experience with [f-18]flt in children and it would be inappropriate to study individuals under the age of 18 until more safety data is available.
boolean
C0001779 (UMLS CUI [1])
Standard of Care
Item
4. after entry into the study, patients are expected to be followed for at least 2 months as part of standard of care.
boolean
C2936643 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardians
Item
5. all patients, or their legal guardians, must sign a written informed consent and hipaa authorization in accordance with institutional guidelines.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Contraceptive methods | Intrauterine Devices | Contraceptives, Oral | Depo-Provera | Norplant | Pregnancy test negative Accepted
Item
6. the patient, if female, must be postmenopausal for a minimum of one year or surgically sterile, or on one of the following methods of birth control for a minimum of one month prior to entry into this study: iud, oral contraceptives, depo-provera or norplant. these criteria can be waived at the discretion of the investigator if the patient's tumor is considered life threatening and the one month wait required is not in the best interest of the patient. negative pregnancy test is accepted.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C0699700 (UMLS CUI [6])
C1145675 (UMLS CUI [7])
C0427780 (UMLS CUI [8,1])
C1272684 (UMLS CUI [8,2])
Laboratory Procedures pre treatment | 18F-FLT | Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Serum pregnancy test negative | PET scan
Item
7. pre-treatment laboratory tests for patients receiving [f-18]flt must be performed within 21 days prior to study entry. these must be less than 4 times below or above the upper or lower limit range for the respective laboratory test. the patients have stage iiib/iv or recurrent nsclc and therefore many routine laboratory tests may not be within the typical normal range. using a factor of 4 times above or below the upper or lower value for the normal range for laboratory test will assure ability to recruit patients and maintain safety. in those instances where a value of 4x above the normal range would be inappropriate for inclusion (prothrombin time and partial thromboplastin time) then a value of 2.5x will be used for these two laboratory tests. in those instances when the prothrombin time or partial thromboplastin time are greater than 2.5x the upper limit of normal then such a patient would not be enrolled. the 4x value will be used for all laboratory values except prothrombin time and partial thromboplastin time which cannot be above or below 2.5 times the upper or lower limit of normal (appendix e, [f-18]flt laboratory study results). a negative serum pregnancy test is required within 2 days prior to the pet studies.
boolean
C0022885 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C1432709 (UMLS CUI [2])
C0007131 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0278517 (UMLS CUI [4])
C0033707 (UMLS CUI [5])
C0030605 (UMLS CUI [6])
C0430061 (UMLS CUI [7])
C0032743 (UMLS CUI [8])
Radiology pre treatment | Non-Small Cell Lung Carcinoma TNM clinical staging MRI gadolinium-enhanced | Non-small cell lung cancer recurrent CT | Non-Small Cell Lung Carcinoma TNM clinical staging CT | Non-small cell lung cancer recurrent MRI gadolinium-enhanced
Item
8. pre-treatment radiological clinical scans/studies (gd- enhanced mri or ct to document stage iiib/iv or recurrent nsclc) must be performed within 30 days of study entry.
boolean
C0043299 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0855566 (UMLS CUI [2,3])
C0278517 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0007131 (UMLS CUI [4,1])
C3258246 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C0278517 (UMLS CUI [5,1])
C0855566 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Mismatch | erlotinib U/day | Tarceva U/day | bevacizumab | Avastin | Therapy, Investigational
Item
1. patients will be receiving erlotinib (tarceva) (150 mg/day)and bevacizumab (avastin) (15mg/kg q 21 days) as part of the therapeutic trial. enrollment may not occur if the patient does not meet the enrollment criteria for the therapeutic trial
boolean
C1512693 (UMLS CUI [1,1])
C1881865 (UMLS CUI [1,2])
C1135135 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C1135136 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0796392 (UMLS CUI [4])
C1135130 (UMLS CUI [5])
C0949266 (UMLS CUI [6])
Hypersensitivity Radiopharmaceuticals | Drug Allergy allowed | Hypersensitivity allowed | Autoimmune Diseases allowed
Item
2. patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. patients with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion.
boolean
C0020517 (UMLS CUI [1,1])
C0182638 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0004364 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Possible pregnancy
Item
3. patients who are pregnant or lactating or who suspect they might be pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0425965 (UMLS CUI [3])
Adult | Monitored anesthesia PET scan
Item
4. adult patients who require monitored anesthesia for pet scanning.
boolean
C0001675 (UMLS CUI [1])
C0497677 (UMLS CUI [2,1])
C0032743 (UMLS CUI [2,2])
HIV Seropositivity Due to 18F-FLT Toxicity
Item
5. hiv positive patients due to the previous toxicity noted with flt.
boolean
C0019699 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1432709 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,4])
Claustrophobia | Hospital Stay PET unit Unable
Item
6. claustrophobia or inability to remain stationary within the pet scanner for 90 minutes.
boolean
C0008909 (UMLS CUI [1])
C3489408 (UMLS CUI [2,1])
C0182349 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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