ID

30390

Beschreibung

18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00775268

Link

https://clinicaltrials.gov/show/NCT00775268

Stichworte

Versionen (1)
  1. 01.06.18 01.06.18 -
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See clinicaltrials.gov

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1. Juni 2018

DOI

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Eligibility Lymphoma NCT00775268

Englisch

Eligibility Lymphoma NCT00775268

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00775268
Criteria
Beschreibung

Criteria

participant must be enrolled in a lymphoma therapy study at the nih clinical center or be enrolled in the calgb 50303 study at another site or undergoing a new course of treatment of lymphoma at another facility.
Beschreibung

Study Subject Participation Status | Therapeutic procedure Lymphoma | CALGB Clinical Trial Specified | Treatment Course New Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0024299
UMLS CUI [3,1]
C1516238
UMLS CUI [3,2]
C0008976
UMLS CUI [3,3]
C0205369
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0750729
UMLS CUI [4,3]
C0205314
UMLS CUI [4,4]
C0024299
participants must have a clinical course consistent with lymphoma and have available documentation of lymphoma from either the nci or from an outside pathology laboratory.
Beschreibung

Clinical course Consistent with Lymphoma | Documentation Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449259
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0920316
UMLS CUI [2,2]
C0024299
participant must be 18 years or older.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance score of 0 or 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
ability to provide informed consent. all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
for subjects enrolling in early response arm
Beschreibung

Enrollment Response Early Arm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C1279919
UMLS CUI [1,4]
C1522541
must be enrolled in calgb 50303 or a lymphoma therapy study at the nih clinical center or undergoing a new course of treatment of lymphoma at another facility
Beschreibung

Study Subject Participation Status | CALGB Clinical Trial Specified | Therapeutic procedure Lymphoma | Treatment Course New Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1516238
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0024299
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0750729
UMLS CUI [4,3]
C0205314
UMLS CUI [4,4]
C0024299
must not have begun lymphoma therapy for this tumor occurrence/ relapse
Beschreibung

Absence Therapeutic procedure Lymphoma Current | Absence Therapeutic procedure Recurrent Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0024299
UMLS CUI [1,4]
C0521116
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C4525062
prior completed therapy does not affect eligibility
Beschreibung

Eligibility Independent of Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C1514463
for subjects enrolling in the residual fdg avid mass arm
Beschreibung

Enrollment Protocol Treatment Arm | Tumor Mass Residual FDG Avidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C1522541
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C1609982
UMLS CUI [2,3]
C0046056
UMLS CUI [2,4]
C1510996
must have a residual fdg pet positive mass greater than equal to 1cm, with uptake greater than that of mediastinal blood pool.
Beschreibung

Tumor Mass Residual Size | FDG-PET Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3273930
UMLS CUI [1,2]
C1609982
UMLS CUI [1,3]
C0456389
UMLS CUI [2,1]
C3641247
UMLS CUI [2,2]
C1514241
participant will undergo a repeat fdg pet/ct scan if the original fdg/pet imaging performed at an outside institution is not of adequate imaging quality for subjects enrolling in the residual fdg mass arm.
Beschreibung

FDG-PET and CT Scan Repeat | FDG-PET Original Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4521453
UMLS CUI [1,2]
C0205341
UMLS CUI [2,1]
C3641247
UMLS CUI [2,2]
C0205313
UMLS CUI [2,3]
C0205412
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergy to fluorothymidine.
Beschreibung

Hypersensitivity 18F-FLT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1432709
participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
Beschreibung

Delay Standard of Care Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205421
UMLS CUI [1,2]
C2936643
UMLS CUI [1,3]
C0205539
participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.
Beschreibung

Comorbidity Interferes with Interventional procedure | Mental condition Interferes with Interventional procedure | Comorbidity Interferes with Research results | Mental condition Interferes with Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0184661
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0184661
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
participants with severe claustrophobia not relieved by oral anxiolytic medication or patients weighing greater than 136 kg (weight limit for scanner table).
Beschreibung

Claustrophobia Severe | Anti-Anxiety Agents Oral Absent | Body Weight Very high

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0040616
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0005910
UMLS CUI [3,2]
C0442804
other medical conditions deemed by the pi or associates to make the patient ineligible for protocol procedures.
Beschreibung

Other medical condition Ineligibility Interventional procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C0184661
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Ähnliche Modelle

Eligibility Lymphoma NCT00775268

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00775268
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Study Subject Participation Status | Therapeutic procedure Lymphoma | CALGB Clinical Trial Specified | Treatment Course New Lymphoma
Item
participant must be enrolled in a lymphoma therapy study at the nih clinical center or be enrolled in the calgb 50303 study at another site or undergoing a new course of treatment of lymphoma at another facility.
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
C1516238 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0750729 (UMLS CUI [4,2])
C0205314 (UMLS CUI [4,3])
C0024299 (UMLS CUI [4,4])
Clinical course Consistent with Lymphoma | Documentation Lymphoma
Item
participants must have a clinical course consistent with lymphoma and have available documentation of lymphoma from either the nci or from an outside pathology laboratory.
boolean
C0449259 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0920316 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
Age
Item
participant must be 18 years or older.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
ability to provide informed consent. all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
boolean
C0021430 (UMLS CUI [1])
Enrollment Response Early Arm
Item
for subjects enrolling in early response arm
boolean
C1516879 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C1522541 (UMLS CUI [1,4])
Study Subject Participation Status | CALGB Clinical Trial Specified | Therapeutic procedure Lymphoma | Treatment Course New Lymphoma
Item
must be enrolled in calgb 50303 or a lymphoma therapy study at the nih clinical center or undergoing a new course of treatment of lymphoma at another facility
boolean
C2348568 (UMLS CUI [1])
C1516238 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0750729 (UMLS CUI [4,2])
C0205314 (UMLS CUI [4,3])
C0024299 (UMLS CUI [4,4])
Absence Therapeutic procedure Lymphoma Current | Absence Therapeutic procedure Recurrent Lymphoma
Item
must not have begun lymphoma therapy for this tumor occurrence/ relapse
boolean
C0332197 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C4525062 (UMLS CUI [2,3])
Eligibility Independent of Prior Therapy
Item
prior completed therapy does not affect eligibility
boolean
C1548635 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
Enrollment Protocol Treatment Arm | Tumor Mass Residual FDG Avidity
Item
for subjects enrolling in the residual fdg avid mass arm
boolean
C1516879 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C3273930 (UMLS CUI [2,1])
C1609982 (UMLS CUI [2,2])
C0046056 (UMLS CUI [2,3])
C1510996 (UMLS CUI [2,4])
Tumor Mass Residual Size | FDG-PET Positive
Item
must have a residual fdg pet positive mass greater than equal to 1cm, with uptake greater than that of mediastinal blood pool.
boolean
C3273930 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C3641247 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
FDG-PET and CT Scan Repeat | FDG-PET Original Inadequate
Item
participant will undergo a repeat fdg pet/ct scan if the original fdg/pet imaging performed at an outside institution is not of adequate imaging quality for subjects enrolling in the residual fdg mass arm.
boolean
C4521453 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C3641247 (UMLS CUI [2,1])
C0205313 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity 18F-FLT
Item
known allergy to fluorothymidine.
boolean
C0020517 (UMLS CUI [1,1])
C1432709 (UMLS CUI [1,2])
Delay Standard of Care Scheduled
Item
participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
boolean
C0205421 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Comorbidity Interferes with Interventional procedure | Mental condition Interferes with Interventional procedure | Comorbidity Interferes with Research results | Mental condition Interferes with Research results
Item
participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
Claustrophobia Severe | Anti-Anxiety Agents Oral Absent | Body Weight Very high
Item
participants with severe claustrophobia not relieved by oral anxiolytic medication or patients weighing greater than 136 kg (weight limit for scanner table).
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0040616 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0005910 (UMLS CUI [3,1])
C0442804 (UMLS CUI [3,2])
Other medical condition Ineligibility Interventional procedure
Item
other medical conditions deemed by the pi or associates to make the patient ineligible for protocol procedures.
boolean
C3843040 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
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