ID

31067

Beschrijving

Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00377195

Link

https://clinicaltrials.gov/show/NCT00377195

Trefwoorden

Versies (1)
  1. 16-07-18 16-07-18 -
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See clinicaltrials.gov

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16 juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Non-gastric Marginal Zone Lymphoma NCT00377195

Engels

Eligibility Non-gastric Marginal Zone Lymphoma NCT00377195

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients of at least 18 years old with histologically documented non-gastric marginal zone lymphoma.
Beschrijving

Age | Marginal Zone B-Cell Lymphoma | Absence Involvement Gastric

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1367654
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C1704242
disease limited to stages i and ii after adequate staging (see appendix ii), patients with stage iv with extranodal disease confined to paired organs (e.g. salivary glands) and including any local extension of this disease into adjacent tissues. patients with involved lymph nodes on the same side of the diaphragm in addition to paired organ involvement are also eligible, provided all involved tumour sites, nodal and extranodal, can be irradiated to 30 gy within the tolerance of the relevant normal tissues. if paired organ involvement was regarded as a single extranodal site (rather than 2 separate sites and hence stage iv), eligible patients would then be regarded as having stage ie or iie disease. patients with wider dissemination (bone marrow, liver etc) are ineligible.
Beschrijving

Disease Ann Arbor lymphoma staging system | Lymph Node Involvement | Therapeutic radiology procedure Tumor site Involved

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0432516
UMLS CUI [2]
C0806692
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0475445
UMLS CUI [3,3]
C1314939
anticipated life expectancy > 2 years
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
given written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
been assessed by a radiation oncologist
Beschrijving

Patient Assessed Radiation Oncologist

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C1514693
agree to undergo breath testing for h. pylori and/or oesophagogastroduodenoscopy to exclude active infection with helicobacter pylori
Beschrijving

Breath Tests Helicobacter pylori | Esophagogastroduodenoscopy Excludes Infection caused by Helicobacter pylori

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006153
UMLS CUI [1,2]
C0079488
UMLS CUI [2,1]
C0079304
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0850666
must be available for long-term follow up
Beschrijving

Patient Available Follow-up Long-term

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
UMLS CUI [1,4]
C0443252
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
splenic marginal zone lymphoma
Beschrijving

Splenic Marginal Zone B-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0349632
received previous locoregional radiotherapy
Beschrijving

Prior radiation therapy Locoregional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1947913
a medical contraindication to radiotherapy
Beschrijving

Medical contraindication Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1522449
any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years
Beschrijving

Malignant Neoplasms | Exception Curative treatment Skin carcinoma | Exception Curative treatment Malignant melanoma Level | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Disease Free of

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0025202
UMLS CUI [3,4]
C0441889
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
such extensive involvement of the thorax that treatment with radiotherapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed
Beschrijving

Thorax Involvement Extensive | Therapeutic radiology procedure Only High risk | Irradiation of lung Excessive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0817096
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0205231
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205171
UMLS CUI [2,3]
C0332167
UMLS CUI [3,1]
C2169076
UMLS CUI [3,2]
C0442802
suspected or confirmed pregnancy
Beschrijving

Pregnancy Suspected | Pregnancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0032961
transformation to large cell lymphoma or other aggressive histology
Beschrijving

Transformation Large cell lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C0024302
disease that is widely disseminated (bone marrow, liver etc)
Beschrijving

Disease Disseminated | Bone Marrow | Liver

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205221
UMLS CUI [2]
C0005953
UMLS CUI [3]
C0023884
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Similar models

Eligibility Non-gastric Marginal Zone Lymphoma NCT00377195

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Marginal Zone B-Cell Lymphoma | Absence Involvement Gastric
Item
patients of at least 18 years old with histologically documented non-gastric marginal zone lymphoma.
boolean
C0001779 (UMLS CUI [1])
C1367654 (UMLS CUI [2])
C0332197 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C1704242 (UMLS CUI [3,3])
Disease Ann Arbor lymphoma staging system | Lymph Node Involvement | Therapeutic radiology procedure Tumor site Involved
Item
disease limited to stages i and ii after adequate staging (see appendix ii), patients with stage iv with extranodal disease confined to paired organs (e.g. salivary glands) and including any local extension of this disease into adjacent tissues. patients with involved lymph nodes on the same side of the diaphragm in addition to paired organ involvement are also eligible, provided all involved tumour sites, nodal and extranodal, can be irradiated to 30 gy within the tolerance of the relevant normal tissues. if paired organ involvement was regarded as a single extranodal site (rather than 2 separate sites and hence stage iv), eligible patients would then be regarded as having stage ie or iie disease. patients with wider dissemination (bone marrow, liver etc) are ineligible.
boolean
C0012634 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C0806692 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0475445 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
Life Expectancy
Item
anticipated life expectancy > 2 years
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
given written informed consent
boolean
C0021430 (UMLS CUI [1])
Patient Assessed Radiation Oncologist
Item
been assessed by a radiation oncologist
boolean
C0030705 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1514693 (UMLS CUI [1,3])
Breath Tests Helicobacter pylori | Esophagogastroduodenoscopy Excludes Infection caused by Helicobacter pylori
Item
agree to undergo breath testing for h. pylori and/or oesophagogastroduodenoscopy to exclude active infection with helicobacter pylori
boolean
C0006153 (UMLS CUI [1,1])
C0079488 (UMLS CUI [1,2])
C0079304 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0850666 (UMLS CUI [2,3])
Patient Available Follow-up Long-term
Item
must be available for long-term follow up
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C0443252 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Splenic Marginal Zone B-Cell Lymphoma
Item
splenic marginal zone lymphoma
boolean
C0349632 (UMLS CUI [1])
Prior radiation therapy Locoregional
Item
received previous locoregional radiotherapy
boolean
C0279134 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
Medical contraindication Therapeutic radiology procedure
Item
a medical contraindication to radiotherapy
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Curative treatment Skin carcinoma | Exception Curative treatment Malignant melanoma Level | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Disease Free of
Item
any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0025202 (UMLS CUI [3,3])
C0441889 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
Thorax Involvement Extensive | Therapeutic radiology procedure Only High risk | Irradiation of lung Excessive
Item
such extensive involvement of the thorax that treatment with radiotherapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed
boolean
C0817096 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0205231 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0332167 (UMLS CUI [2,3])
C2169076 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
Pregnancy Suspected | Pregnancy
Item
suspected or confirmed pregnancy
boolean
C0032961 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
Transformation Large cell lymphoma
Item
transformation to large cell lymphoma or other aggressive histology
boolean
C0040682 (UMLS CUI [1,1])
C0024302 (UMLS CUI [1,2])
Disease Disseminated | Bone Marrow | Liver
Item
disease that is widely disseminated (bone marrow, liver etc)
boolean
C0012634 (UMLS CUI [1,1])
C0205221 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2])
C0023884 (UMLS CUI [3])
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