ID

24579

Descripción

Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00915096

Link

https://clinicaltrials.gov/show/NCT00915096

Palabras clave

Versiones (1)
  1. 7/8/17 7/8/17 -
Subido en

7 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT00915096

Inglés

Eligibility Lymphoma, Follicular NCT00915096

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with malignant non-hodgkin follicular lymphoma (histologic grade 1 to 3 in the who classification), histologically confirmed,
Descripción

Follicular Lymphoma WHO tumor classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C1301142
patients who have not previously been treated for this disease,
Descripción

Disease untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332155
introducing one of the criteria for high tumor burden,
Descripción

Criteria Tumor Burden High

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1449699
UMLS CUI [1,3]
C0205250
patients aged over 18 and under 80 years,
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients whose ecog condition is ≤ 2,
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
patients whose haematological functions are adequate within 28 days preceding the treatment (hemoglobin ≥8,0g/dl; neutrophils ≥1,5e-9/l, platelets ≥100e-9/l),
Descripción

Hematologic function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0032181
patient had the pet examination less than a month before the start of chemotherapy.
Descripción

Positron-Emission Tomography

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032743
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with lymphoma who have already transformed or been treated for this disease,
Descripción

Lymphoma Transformed | Lymphoma Treated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0457344
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C1522326
patients whose lymphoma is stage 3b,
Descripción

Lymphoma WHO tumor classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1301142
patients with impaired central nervous system,
Descripción

Central Nervous System Impaired

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C0221099
patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
Descripción

Adrenal Cortex Hormones Regular | Exception Dose Equivalent Prednisone U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205163
UMLS CUI [2,4]
C0032952
UMLS CUI [2,5]
C0456683
patients who have undergone major surgery during the 28 days preceding the inclusion,
Descripción

major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
patients with low kidney and/or liver function,
Descripción

Decreased renal function | Decreased liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232807
UMLS CUI [2]
C0232744
patients with hiv + or had an infection with hbv or hcv less than 4 weeks. patients with hepatitis b serology is positive unless the sign is related to vaccination,
Descripción

HIV Seropositivity | Hepatitis B | Hepatitis C | HEPATITIS B SEROLOGY POSITIVE | Exception Sign Due to Vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0744838
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0311392
UMLS CUI [5,3]
C0678226
UMLS CUI [5,4]
C0042196
patients whose life expectancy ≤ 6 months,
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
patients sensitive or allergic to murine products,
Descripción

Hypersensitivity Product Murine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C0026809
patients who participated in another clinical trial during the 30 days preceding the recording,
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
patients with other medical problems or psychological succeptibles interfere with the study,
Descripción

Patient Problem Interferes with Clinical Trial | Mental problem Interferes with Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0848067
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
patients under adult supervision.
Descripción

Patient Supervision Adult

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0038842
UMLS CUI [1,3]
C0001675
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Similar models

Eligibility Lymphoma, Follicular NCT00915096

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Follicular Lymphoma WHO tumor classification
Item
patients with malignant non-hodgkin follicular lymphoma (histologic grade 1 to 3 in the who classification), histologically confirmed,
boolean
C0024301 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Disease untreated
Item
patients who have not previously been treated for this disease,
boolean
C0012634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Criteria Tumor Burden High
Item
introducing one of the criteria for high tumor burden,
boolean
C0243161 (UMLS CUI [1,1])
C1449699 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Age
Item
patients aged over 18 and under 80 years,
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
patients whose ecog condition is ≤ 2,
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement
Item
patients whose haematological functions are adequate within 28 days preceding the treatment (hemoglobin ≥8,0g/dl; neutrophils ≥1,5e-9/l, platelets ≥100e-9/l),
boolean
C0221130 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Positron-Emission Tomography
Item
patient had the pet examination less than a month before the start of chemotherapy.
boolean
C0032743 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphoma Transformed | Lymphoma Treated
Item
patients with lymphoma who have already transformed or been treated for this disease,
boolean
C0024299 (UMLS CUI [1,1])
C0457344 (UMLS CUI [1,2])
C0024299 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Lymphoma WHO tumor classification
Item
patients whose lymphoma is stage 3b,
boolean
C0024299 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Central Nervous System Impaired
Item
patients with impaired central nervous system,
boolean
C3714787 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
Adrenal Cortex Hormones Regular | Exception Dose Equivalent Prednisone U/day
Item
patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
boolean
C0001617 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C0032952 (UMLS CUI [2,4])
C0456683 (UMLS CUI [2,5])
major surgery
Item
patients who have undergone major surgery during the 28 days preceding the inclusion,
boolean
C0679637 (UMLS CUI [1])
Decreased renal function | Decreased liver function
Item
patients with low kidney and/or liver function,
boolean
C0232807 (UMLS CUI [1])
C0232744 (UMLS CUI [2])
HIV Seropositivity | Hepatitis B | Hepatitis C | HEPATITIS B SEROLOGY POSITIVE | Exception Sign Due to Vaccination
Item
patients with hiv + or had an infection with hbv or hcv less than 4 weeks. patients with hepatitis b serology is positive unless the sign is related to vaccination,
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0744838 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0311392 (UMLS CUI [5,2])
C0678226 (UMLS CUI [5,3])
C0042196 (UMLS CUI [5,4])
Life Expectancy
Item
patients whose life expectancy ≤ 6 months,
boolean
C0023671 (UMLS CUI [1])
Hypersensitivity Product Murine
Item
patients sensitive or allergic to murine products,
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C0026809 (UMLS CUI [1,3])
Study Subject Participation Status
Item
patients who participated in another clinical trial during the 30 days preceding the recording,
boolean
C2348568 (UMLS CUI [1])
Patient Problem Interferes with Clinical Trial | Mental problem Interferes with Clinical Trial
Item
patients with other medical problems or psychological succeptibles interfere with the study,
boolean
C1254481 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0848067 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Patient Supervision Adult
Item
patients under adult supervision.
boolean
C0030705 (UMLS CUI [1,1])
C0038842 (UMLS CUI [1,2])
C0001675 (UMLS CUI [1,3])
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