ID

35837

Beskrivning

The Palliative Benefit of Involved-site Radiotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02449278

Länk

https://clinicaltrials.gov/show/NCT02449278

Nyckelord

Versioner (1)
  1. 2019-03-26 2019-03-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma NCT02449278

Engelsk

Eligibility Diffuse Large B-cell Lymphoma NCT02449278

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
both male and female aged range from 18 years to 65 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group(ecog) performance status of 0 or 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
all patients had histologically confirmed diffuse large b-cell lymphoma.
Beskrivning

Diffuse Large B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079744
advanced-stage dlbcl patients at newly diagnosed or recurrent without rt in initial management.
Beskrivning

Diffuse Large B-Cell Lymphoma Stage Advanced | Diffuse large B-cell lymphoma recurrent | Therapeutic radiology procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C0205179
UMLS CUI [2]
C0855111
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
adequate organ function.
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
negative pregnancy test.
Beskrivning

Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0427780
signed informed consent document on file.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
woman who were pregnant or lactating.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
with severe local infection or general infective disease.
Beskrivning

Local infection Severe | Communicable Disease General

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1400591
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205246
primary lymphoma in special organ including cuticula, center never system, gastrointestinal tract, testicle, and lung.
Beskrivning

Lymphoma Primary Organ Special | Cuticle | Central Nervous System | Gastrointestinal tract | Testis | Lung

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0205555
UMLS CUI [2]
C2699479
UMLS CUI [3]
C3714787
UMLS CUI [4]
C0017189
UMLS CUI [5]
C0039597
UMLS CUI [6]
C0024109
with other second primary malignancy except cutaneum carcinoma.
Beskrivning

Second Primary Cancer | Exception Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
being or planning to participate in other study.
Beskrivning

Study Subject Participation Status | Study Subject Participation Status Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1301732
any patient who in the opinion of the investigator should not participate in the study.
Beskrivning

Study Subject Participation Status Ineligible

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
withdrawal criteria:
Beskrivning

Withdrawal criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C0243161
patient are free to withdrawal completely from the study at any time upon request.
Beskrivning

Withdrawal Patient Decision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C4527299
patient in the study may be stopped with the patient agreement at any time at the discretion of investigator.
Beskrivning

Study Subject Participation Status Stopped

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1272691
in-field progression on irradiation ongoing.
Beskrivning

Radiation Field Disease Progression | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1882536
UMLS CUI [1,2]
C0242656
UMLS CUI [2]
C1522449
poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.
Beskrivning

Adverse event Chemotherapy | Adverse event Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1522449
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Similar models

Eligibility Diffuse Large B-cell Lymphoma NCT02449278

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
both male and female aged range from 18 years to 65 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group(ecog) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma
Item
all patients had histologically confirmed diffuse large b-cell lymphoma.
boolean
C0079744 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma Stage Advanced | Diffuse large B-cell lymphoma recurrent | Therapeutic radiology procedure Absent
Item
advanced-stage dlbcl patients at newly diagnosed or recurrent without rt in initial management.
boolean
C0079744 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C0855111 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Organ function
Item
adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Pregnancy test negative
Item
negative pregnancy test.
boolean
C0427780 (UMLS CUI [1])
Informed Consent
Item
signed informed consent document on file.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
woman who were pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Local infection Severe | Communicable Disease General
Item
with severe local infection or general infective disease.
boolean
C1400591 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205246 (UMLS CUI [2,2])
Lymphoma Primary Organ Special | Cuticle | Central Nervous System | Gastrointestinal tract | Testis | Lung
Item
primary lymphoma in special organ including cuticula, center never system, gastrointestinal tract, testicle, and lung.
boolean
C0024299 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0205555 (UMLS CUI [1,4])
C2699479 (UMLS CUI [2])
C3714787 (UMLS CUI [3])
C0017189 (UMLS CUI [4])
C0039597 (UMLS CUI [5])
C0024109 (UMLS CUI [6])
Second Primary Cancer | Exception Skin carcinoma
Item
with other second primary malignancy except cutaneum carcinoma.
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Study Subject Participation Status | Study Subject Participation Status Planned
Item
being or planning to participate in other study.
boolean
C2348568 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Study Subject Participation Status Ineligible
Item
any patient who in the opinion of the investigator should not participate in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Withdrawal criteria
Item
withdrawal criteria:
boolean
C1710677 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Withdrawal Patient Decision
Item
patient are free to withdrawal completely from the study at any time upon request.
boolean
C1710677 (UMLS CUI [1,1])
C4527299 (UMLS CUI [1,2])
Study Subject Participation Status Stopped
Item
patient in the study may be stopped with the patient agreement at any time at the discretion of investigator.
boolean
C2348568 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Radiation Field Disease Progression | Therapeutic radiology procedure
Item
in-field progression on irradiation ongoing.
boolean
C1882536 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
Adverse event Chemotherapy | Adverse event Therapeutic radiology procedure
Item
poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.
boolean
C0877248 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
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