ID

21751

Beschreibung

Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00324467

Link

https://clinicaltrials.gov/show/NCT00324467

Stichworte

Versionen (2)
  1. 27.04.17 27.04.17 -
  2. 27.04.17 27.04.17 -
Hochgeladen am

27. April 2017

DOI

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Eligibility Lymphoma, Non-Hodgkin NCT00324467

Englisch

Eligibility Lymphoma, Non-Hodgkin NCT00324467

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
newly diagnosed histologically proven cd-20 positive diffuse large b- cell lymphoma by tissue biopsy, listed under peripheral b-cell neoplasm according to the who/real classification (diffuse large b-cell lymphoma, mediastinal large b-cell lymphoma, t-cell rich b-cell lymphoma, intravascular large b-cell lymphoma)
Beschreibung

Diffuse Large B-Cell Lymphoma CD20 positive Biopsy tissue | Mature (peripheral) B-cell neoplasm WHO tumor classification | Mature (peripheral) B-cell neoplasm REAL classification | Diffuse Large B-Cell Lymphoma | Mediastinal Large B-Cell Lymphoma | T-cell rich large B-cell lymphoma | Intravascular large B-cell lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0882818
UMLS CUI [1,3]
C3864006
UMLS CUI [2,1]
C1532008
UMLS CUI [2,2]
C1301142
UMLS CUI [3,1]
C1532008
UMLS CUI [3,2]
C1688661
UMLS CUI [4]
C0079744
UMLS CUI [5]
C1292754
UMLS CUI [6]
C1321547
UMLS CUI [7]
C0334660
advanced stage disease defined as - patients with stage iii or stage iv disease; or patients with stage i or stage ii disease with one of the following additional criteria: b-symptoms, or disease that is not radio- encompassable within a single involved field, or not a candidate for brief chemotherapy and irradiation, or the presence of bulky disease (any single mass => 10 cm)
Beschreibung

Advanced disease Ann Arbor lymphoma staging system | Disease Ann Arbor lymphoma staging system | B-Symptoms | Involved-Field Radiation Therapy Unsuccessful | Chemotherapy Brief Inappropriate | Therapeutic radiology procedure Brief Inappropriate | Bulky Disease Single mass Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0432516
UMLS CUI [3]
C1706867
UMLS CUI [4,1]
C3826993
UMLS CUI [4,2]
C1272705
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C1879313
UMLS CUI [5,3]
C1548788
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C1879313
UMLS CUI [6,3]
C1548788
UMLS CUI [7,1]
C1511341
UMLS CUI [7,2]
C1265601
UMLS CUI [7,3]
C1301886
previously untreated or treated with up to 3 cycles of standard dose 3- weekly r-chop chemotherapy prior to enrollment (i.e. patients may be enrolled prior to initiation of the fourth cycle of r-chop chemotherapy)
Beschreibung

Patients untreated | Cycles Quantity R-CHOP regimen Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1511572
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0393023
UMLS CUI [2,4]
C0178602
ecog performance status 0,1 or 2 at time of enrollment
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
no evidence of progressive disease while on r-chop chemotherapy
Beschreibung

R-CHOP regimen | Progressive Disease Evidence Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0393023
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0332197
the patient must sign the consent form prior to registration
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a history of any other lymphoproliferative disorder, including prior history of indolent nhl
Beschreibung

Lymphoproliferative Disorder | indolent lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0024314
UMLS CUI [2]
C1334170
patients with a history of prior or concurrent malignancies within 5 years of the current diagnosis, except adequately treated non- melanoma skin cancer, and curatively treated in-situ cancer of the cervix
Beschreibung

Malignant Neoplasms | Skin carcinoma Treated | Curative treatment Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0851140
known hiv infection
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
known hepatitis b virus infection
Beschreibung

Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
pregnancy or lactation. men and women of childbearing age must be using adequate contraception.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
significant renal insufficiency (serum creatinine > 200 mmol/l), unless due to lymphoma
Beschreibung

Renal Insufficiency | Creatinine measurement, serum | Renal Insufficiency Due to Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0024299
significant hepatic insufficiency (serum total bilirubin > 30 mmol/l), unless due to lymphoma
Beschreibung

Hepatic Insufficiency | Serum total bilirubin measurement | Hepatic Insufficiency Due to Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C1278039
UMLS CUI [3,1]
C1306571
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0024299
cardiac contraindication to doxorubicin therapy (e.g. abnormal contractility on echocardiography). if history of cardiac disease, ejection fraction must be within normal limits for age.
Beschreibung

Contraindication cardiac Doxorubicin | Heart Contractility Echocardiography abnormal | Heart Diseases | Ejection fraction normal Age Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0013089
UMLS CUI [2,1]
C1258017
UMLS CUI [2,2]
C0476369
UMLS CUI [3]
C0018799
UMLS CUI [4,1]
C1535947
UMLS CUI [4,2]
C0001779
UMLS CUI [4,3]
C0439849
neurologic contraindication to vincristine (e.g. peripheral neuropathy)
Beschreibung

Contraindication Neurologic Vincristine | Peripheral Neuropathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0205494
UMLS CUI [1,3]
C0042679
UMLS CUI [2]
C0031117
absolute neutrophil count <1.5 x 109/l (unless due to bone marrow involvement with lymphoma or due to initiation of r-chop chemotherapy)
Beschreibung

Absolute neutrophil count | Absolute neutrophil count Due to Lymphoma involves bone marrow | Absolute neutrophil count Due to R-CHOP regimen

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C0948762
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1301440
UMLS CUI [3,1]
C0948762
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0393023
platelet count < 100 x 109/l (unless due to splenomegaly, bone marrow involvement with lymphoma or due to initiation of r-chop chemotherapy)
Beschreibung

Platelet Count measurement | Platelet count Due to Splenomegaly | Platelet count Due to Lymphoma involves bone marrow | Platelet count Due to R-CHOP regimen

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C1287267
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0038002
UMLS CUI [3,1]
C1287267
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C1301440
UMLS CUI [4,1]
C1287267
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0393023
evidence of active systemic infection
Beschreibung

Sepsis Evidence of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0332120
any medical condition that in the opinion of the investigator would compromise treatment delivery, add toxicity or impair assessment
Beschreibung

Medical condition compromises Therapeutic procedure | Medical condition Increasing Toxicity | Medical condition Impairing Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0442808
UMLS CUI [2,3]
C0600688
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C1516048
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Ähnliche Modelle

Eligibility Lymphoma, Non-Hodgkin NCT00324467

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma CD20 positive Biopsy tissue | Mature (peripheral) B-cell neoplasm WHO tumor classification | Mature (peripheral) B-cell neoplasm REAL classification | Diffuse Large B-Cell Lymphoma | Mediastinal Large B-Cell Lymphoma | T-cell rich large B-cell lymphoma | Intravascular large B-cell lymphoma
Item
newly diagnosed histologically proven cd-20 positive diffuse large b- cell lymphoma by tissue biopsy, listed under peripheral b-cell neoplasm according to the who/real classification (diffuse large b-cell lymphoma, mediastinal large b-cell lymphoma, t-cell rich b-cell lymphoma, intravascular large b-cell lymphoma)
boolean
C0079744 (UMLS CUI [1,1])
C0882818 (UMLS CUI [1,2])
C3864006 (UMLS CUI [1,3])
C1532008 (UMLS CUI [2,1])
C1301142 (UMLS CUI [2,2])
C1532008 (UMLS CUI [3,1])
C1688661 (UMLS CUI [3,2])
C0079744 (UMLS CUI [4])
C1292754 (UMLS CUI [5])
C1321547 (UMLS CUI [6])
C0334660 (UMLS CUI [7])
Advanced disease Ann Arbor lymphoma staging system | Disease Ann Arbor lymphoma staging system | B-Symptoms | Involved-Field Radiation Therapy Unsuccessful | Chemotherapy Brief Inappropriate | Therapeutic radiology procedure Brief Inappropriate | Bulky Disease Single mass Diameter
Item
advanced stage disease defined as - patients with stage iii or stage iv disease; or patients with stage i or stage ii disease with one of the following additional criteria: b-symptoms, or disease that is not radio- encompassable within a single involved field, or not a candidate for brief chemotherapy and irradiation, or the presence of bulky disease (any single mass => 10 cm)
boolean
C0679246 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0432516 (UMLS CUI [2,2])
C1706867 (UMLS CUI [3])
C3826993 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0392920 (UMLS CUI [5,1])
C1879313 (UMLS CUI [5,2])
C1548788 (UMLS CUI [5,3])
C1522449 (UMLS CUI [6,1])
C1879313 (UMLS CUI [6,2])
C1548788 (UMLS CUI [6,3])
C1511341 (UMLS CUI [7,1])
C1265601 (UMLS CUI [7,2])
C1301886 (UMLS CUI [7,3])
Patients untreated | Cycles Quantity R-CHOP regimen Dose
Item
previously untreated or treated with up to 3 cycles of standard dose 3- weekly r-chop chemotherapy prior to enrollment (i.e. patients may be enrolled prior to initiation of the fourth cycle of r-chop chemotherapy)
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1511572 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0393023 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
ECOG performance status
Item
ecog performance status 0,1 or 2 at time of enrollment
boolean
C1520224 (UMLS CUI [1])
R-CHOP regimen | Progressive Disease Evidence Absent
Item
no evidence of progressive disease while on r-chop chemotherapy
boolean
C0393023 (UMLS CUI [1])
C1335499 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Informed Consent
Item
the patient must sign the consent form prior to registration
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphoproliferative Disorder | indolent lymphoma
Item
patients with a history of any other lymphoproliferative disorder, including prior history of indolent nhl
boolean
C0024314 (UMLS CUI [1])
C1334170 (UMLS CUI [2])
Malignant Neoplasms | Skin carcinoma Treated | Curative treatment Carcinoma in situ of uterine cervix
Item
patients with a history of prior or concurrent malignancies within 5 years of the current diagnosis, except adequately treated non- melanoma skin cancer, and curatively treated in-situ cancer of the cervix
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1273390 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
HIV Infection
Item
known hiv infection
boolean
C0019693 (UMLS CUI [1])
Hepatitis B
Item
known hepatitis b virus infection
boolean
C0019163 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnancy or lactation. men and women of childbearing age must be using adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Renal Insufficiency | Creatinine measurement, serum | Renal Insufficiency Due to Lymphoma
Item
significant renal insufficiency (serum creatinine > 200 mmol/l), unless due to lymphoma
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
Hepatic Insufficiency | Serum total bilirubin measurement | Hepatic Insufficiency Due to Lymphoma
Item
significant hepatic insufficiency (serum total bilirubin > 30 mmol/l), unless due to lymphoma
boolean
C1306571 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1306571 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
Contraindication cardiac Doxorubicin | Heart Contractility Echocardiography abnormal | Heart Diseases | Ejection fraction normal Age Related
Item
cardiac contraindication to doxorubicin therapy (e.g. abnormal contractility on echocardiography). if history of cardiac disease, ejection fraction must be within normal limits for age.
boolean
C1301624 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0013089 (UMLS CUI [1,3])
C1258017 (UMLS CUI [2,1])
C0476369 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C1535947 (UMLS CUI [4,1])
C0001779 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
Contraindication Neurologic Vincristine | Peripheral Neuropathy
Item
neurologic contraindication to vincristine (e.g. peripheral neuropathy)
boolean
C1301624 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0042679 (UMLS CUI [1,3])
C0031117 (UMLS CUI [2])
Absolute neutrophil count | Absolute neutrophil count Due to Lymphoma involves bone marrow | Absolute neutrophil count Due to R-CHOP regimen
Item
absolute neutrophil count <1.5 x 109/l (unless due to bone marrow involvement with lymphoma or due to initiation of r-chop chemotherapy)
boolean
C0948762 (UMLS CUI [1])
C0948762 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1301440 (UMLS CUI [2,3])
C0948762 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0393023 (UMLS CUI [3,3])
Platelet Count measurement | Platelet count Due to Splenomegaly | Platelet count Due to Lymphoma involves bone marrow | Platelet count Due to R-CHOP regimen
Item
platelet count < 100 x 109/l (unless due to splenomegaly, bone marrow involvement with lymphoma or due to initiation of r-chop chemotherapy)
boolean
C0032181 (UMLS CUI [1])
C1287267 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0038002 (UMLS CUI [2,3])
C1287267 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C1301440 (UMLS CUI [3,3])
C1287267 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0393023 (UMLS CUI [4,3])
Sepsis Evidence of
Item
evidence of active systemic infection
boolean
C0243026 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Medical condition compromises Therapeutic procedure | Medical condition Increasing Toxicity | Medical condition Impairing Assessment
Item
any medical condition that in the opinion of the investigator would compromise treatment delivery, add toxicity or impair assessment
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0442808 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
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