ID

36292

Beschrijving

Pilot Project for Creation of the Diffuse Large B-cell Lymphoma (DLBCL) Response Prediction Model; ODM derived from: https://clinicaltrials.gov/show/NCT02405078

Link

https://clinicaltrials.gov/show/NCT02405078

Trefwoorden

Versies (1)
  1. 30-04-19 30-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma NCT02405078

Engels

Eligibility Lymphoma NCT02405078

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02405078
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years or older at the time of screening.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. subject/legal representative willing and able to provide written informed consent.
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
3. histologically confirmed aggressive b-cell dlbcl, including fl transforming to dlbcl.
Beschrijving

Diffuse Large B-Cell Lymphoma | Follicular Lymphoma Transformation Diffuse Large B-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079744
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0040682
UMLS CUI [2,3]
C0079744
4. willing to provide existing relapse-confirmatory dlbcl tumor sample.
Beschrijving

Diffuse large B-cell lymphoma recurrent Tumor tissue sample

Datatype

boolean

Alias
UMLS CUI [1,1]
C0855111
UMLS CUI [1,2]
C0475358
5. relapsed from or refractory to at least one treatment containing rituximab combined with anthracycline-based chemotherapy.
Beschrijving

Recurrent disease | Refractory Disease | Combined Modality Therapy | rituximab | Chemotherapy Anthracyclines Based

Datatype

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0393022
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0282564
UMLS CUI [5,3]
C1705938
6. ct scans showing involvement of 1 or more clearly demarcated lesions with a long axis > 1.5 cm and short axis >/=1.0 cm.
Beschrijving

Lesion Quantity Long axis CT scan | Lesion Quantity Short axis CT scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0522487
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0522488
UMLS CUI [2,4]
C0040405
7. baseline fdg pet/ct scans must demonstrate at least one hypermetabolic lesion as defined by the deauville criteria (52) localizing to ct-defined anatomical tumor sites.
Beschrijving

Hypermetabolism FDG-PET CT Scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342952
UMLS CUI [1,2]
C4521453
8. suitable candidate for therapy with high-dose chemotherapy and asct as determined by the treating physician.
Beschrijving

Patient Appropriate High-dose chemotherapy | Patient Appropriate Transplantation of autologous hematopoietic stem cell

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1328050
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C1831743
9. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
10. life expectancy of >/=12 weeks as estimated by the treating physician.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
11. negative serum beta-human chorionic gonadotropin (beta-hcg) test (women of childbearing potential only).
Beschrijving

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
12. adequate organ function defined as follows: serum creatinine </= 1.5 × uln or calculated creatinine clearance (crcl) >/= 50 ml/min as determined by the cockcroft-gault equation.
Beschrijving

Organ function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any condition that, in the opinion of the investigator, would interfere with the interpretation of study results or subject safety including non-malignant fdg avid diseases such as sarcoidosis or other granulomatous disease.
Beschrijving

Condition Interferes with Interpretation Research results | Condition Interferes with Patient safety | Sarcoidosis | Granulomatous disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0459471
UMLS CUI [1,4]
C0683954
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1113679
UMLS CUI [3]
C0036202
UMLS CUI [4]
C0740451
2. uncontrolled diabetes mellitus.
Beschrijving

Diabetic - poor control

Datatype

boolean

Alias
UMLS CUI [1]
C0421258
3. concurrent enrollment in another clinical study where they are receiving non-standard salvage chemotherapy, (i.e., concurrent enrollment is allowable if the patient is receiving standard salvage chemotherapy and research imaging is allowed).
Beschrijving

Study Subject Participation Status | Chemotherapy Except Standard therapy

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C2936643
4. history of serious allergy or reaction to any component of rice or rdhap formulations that would prevent administration.
Beschrijving

Hypersensitivity Serious Component Rice | Allergic Reaction Serious Component Rice | Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1705248
UMLS CUI [1,4]
C0035567
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1705248
UMLS CUI [2,4]
C0035567
UMLS CUI [3]
C3846158
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Similar models

Eligibility Lymphoma NCT02405078

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02405078
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 years or older at the time of screening.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
2. subject/legal representative willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Diffuse Large B-Cell Lymphoma | Follicular Lymphoma Transformation Diffuse Large B-Cell Lymphoma
Item
3. histologically confirmed aggressive b-cell dlbcl, including fl transforming to dlbcl.
boolean
C0079744 (UMLS CUI [1])
C0024301 (UMLS CUI [2,1])
C0040682 (UMLS CUI [2,2])
C0079744 (UMLS CUI [2,3])
Diffuse large B-cell lymphoma recurrent Tumor tissue sample
Item
4. willing to provide existing relapse-confirmatory dlbcl tumor sample.
boolean
C0855111 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Recurrent disease | Refractory Disease | Combined Modality Therapy | rituximab | Chemotherapy Anthracyclines Based
Item
5. relapsed from or refractory to at least one treatment containing rituximab combined with anthracycline-based chemotherapy.
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0393022 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C0282564 (UMLS CUI [5,2])
C1705938 (UMLS CUI [5,3])
Lesion Quantity Long axis CT scan | Lesion Quantity Short axis CT scan
Item
6. ct scans showing involvement of 1 or more clearly demarcated lesions with a long axis > 1.5 cm and short axis >/=1.0 cm.
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0522487 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0522488 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
Hypermetabolism FDG-PET CT Scan
Item
7. baseline fdg pet/ct scans must demonstrate at least one hypermetabolic lesion as defined by the deauville criteria (52) localizing to ct-defined anatomical tumor sites.
boolean
C0342952 (UMLS CUI [1,1])
C4521453 (UMLS CUI [1,2])
Patient Appropriate High-dose chemotherapy | Patient Appropriate Transplantation of autologous hematopoietic stem cell
Item
8. suitable candidate for therapy with high-dose chemotherapy and asct as determined by the treating physician.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1328050 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C1831743 (UMLS CUI [2,3])
ECOG performance status
Item
9. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
10. life expectancy of >/=12 weeks as estimated by the treating physician.
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
11. negative serum beta-human chorionic gonadotropin (beta-hcg) test (women of childbearing potential only).
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Organ function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
12. adequate organ function defined as follows: serum creatinine </= 1.5 × uln or calculated creatinine clearance (crcl) >/= 50 ml/min as determined by the cockcroft-gault equation.
boolean
C0678852 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Condition Interferes with Interpretation Research results | Condition Interferes with Patient safety | Sarcoidosis | Granulomatous disorder
Item
1. any condition that, in the opinion of the investigator, would interfere with the interpretation of study results or subject safety including non-malignant fdg avid diseases such as sarcoidosis or other granulomatous disease.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0036202 (UMLS CUI [3])
C0740451 (UMLS CUI [4])
Diabetic - poor control
Item
2. uncontrolled diabetes mellitus.
boolean
C0421258 (UMLS CUI [1])
Study Subject Participation Status | Chemotherapy Except Standard therapy
Item
3. concurrent enrollment in another clinical study where they are receiving non-standard salvage chemotherapy, (i.e., concurrent enrollment is allowable if the patient is receiving standard salvage chemotherapy and research imaging is allowed).
boolean
C2348568 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
Hypersensitivity Serious Component Rice | Allergic Reaction Serious Component Rice | Other Coding
Item
4. history of serious allergy or reaction to any component of rice or rdhap formulations that would prevent administration.
boolean
C0020517 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0035567 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0035567 (UMLS CUI [2,4])
C3846158 (UMLS CUI [3])
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