ID

41216

Descrição

FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01410630

Link

https://clinicaltrials.gov/show/NCT01410630

Palavras-chave

Versões (1)
  1. 18/07/2020 18/07/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

18 de julho de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma NCT01410630

Inglês

Eligibility Lymphoma NCT01410630

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01410630
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have a histologic or cytological diagnosis of de novo dlbcl and be scheduled to receive first line chemotherapy with r-chop given every 21 days (r-chop-21) within 6 weeks of their enrollment and for 6 cycles.
Descrição

Diffuse Large B-Cell Lymphoma de novo | First line Chemotherapy Scheduled | R-CHOP Regimen | Chemotherapy cycle Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0205539
UMLS CUI [3]
C0393023
UMLS CUI [4,1]
C1302181
UMLS CUI [4,2]
C1265611
patients must be >=18 years of age, but there will be no discrimination based on gender, race, creed, or ethnic background.
Descrição

Age | Gender | Racial group | Faith | Ethnic group

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0034510
UMLS CUI [4]
C0681191
UMLS CUI [5]
C0015031
patients must have an ecog performance status of 0-2.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
patients must sign an informed consent, and be mentally responsible.
Descrição

Informed Consent | Legal capacity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0683673
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with significant concurrent medical complications that in the judgment of the principal investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies.
Descrição

Complication Affecting Completion of clinical trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2732579
patients with history of prior lymphoma (e.g., follicular lymphoma) and/or second cancers other than basal cell carcinoma.
Descrição

Lymphoma Previous | Lymphoma, Follicular | Second Primary Cancers | Exception Basal cell carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0024301
UMLS CUI [3]
C0751623
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
patients planned to be treated with r-chop-14 (i.e., r-chop given every 14 days) will be excluded (this should be extremely rare, if at all, since r-chop-21 is the standard treatment.
Descrição

R-CHOP Regimen Time Interval Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0393023
UMLS CUI [1,2]
C0872291
UMLS CUI [1,3]
C0205539
patients who are scheduled to receive rituxan or any other therapy (e.g., xrt, radioimmunotherapy) as adjuvant therapy after completion of r-chop-21.
Descrição

Rituxan | X-Ray Therapy | Radioimmunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0732355
UMLS CUI [2]
C0043308
UMLS CUI [3]
C0085101
pregnant women will be excluded.
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for the duration of study participation. the effects of flt on the developing human fetus are unknown. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. a screening urine human chorionic gonadtropin (hcg) (pregnancy test) will be administered in nuclear medicine to women of childbearing potential before each flt scan and pregnant women will be stopped from participating further in this study.
Descrição

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal Contraception | Contraception, Barrier | Sexual Abstinence | Childbearing Potential Urine hCG pregnancy test

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C2188702
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Similar models

Eligibility Lymphoma NCT01410630

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01410630
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma de novo | First line Chemotherapy Scheduled | R-CHOP Regimen | Chemotherapy cycle Quantity
Item
all patients must have a histologic or cytological diagnosis of de novo dlbcl and be scheduled to receive first line chemotherapy with r-chop given every 21 days (r-chop-21) within 6 weeks of their enrollment and for 6 cycles.
boolean
C0079744 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0393023 (UMLS CUI [3])
C1302181 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Age | Gender | Racial group | Faith | Ethnic group
Item
patients must be >=18 years of age, but there will be no discrimination based on gender, race, creed, or ethnic background.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0034510 (UMLS CUI [3])
C0681191 (UMLS CUI [4])
C0015031 (UMLS CUI [5])
ECOG performance status
Item
patients must have an ecog performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Legal capacity
Item
patients must sign an informed consent, and be mentally responsible.
boolean
C0021430 (UMLS CUI [1])
C0683673 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Complication Affecting Completion of clinical trial
Item
subjects with significant concurrent medical complications that in the judgment of the principal investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies.
boolean
C0009566 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Lymphoma Previous | Lymphoma, Follicular | Second Primary Cancers | Exception Basal cell carcinoma
Item
patients with history of prior lymphoma (e.g., follicular lymphoma) and/or second cancers other than basal cell carcinoma.
boolean
C0024299 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2])
C0751623 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
R-CHOP Regimen Time Interval Scheduled
Item
patients planned to be treated with r-chop-14 (i.e., r-chop given every 14 days) will be excluded (this should be extremely rare, if at all, since r-chop-21 is the standard treatment.
boolean
C0393023 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Rituxan | X-Ray Therapy | Radioimmunotherapy
Item
patients who are scheduled to receive rituxan or any other therapy (e.g., xrt, radioimmunotherapy) as adjuvant therapy after completion of r-chop-21.
boolean
C0732355 (UMLS CUI [1])
C0043308 (UMLS CUI [2])
C0085101 (UMLS CUI [3])
Pregnancy
Item
pregnant women will be excluded.
boolean
C0032961 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal Contraception | Contraception, Barrier | Sexual Abstinence | Childbearing Potential Urine hCG pregnancy test
Item
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for the duration of study participation. the effects of flt on the developing human fetus are unknown. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. a screening urine human chorionic gonadtropin (hcg) (pregnancy test) will be administered in nuclear medicine to women of childbearing potential before each flt scan and pregnant women will be stopped from participating further in this study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C2188702 (UMLS CUI [6,2])
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