ID

4843

Description

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00071084

Link

http://clinicaltrials.gov/ct2/show/record/NCT00071084

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/11/14 4/11/14 - Julian Varghese
  3. 4/11/14 4/11/14 - Julian Varghese
  4. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 11, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility Criteria NCT00071084

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion
Description

Inclusion

Medical diagnosis of CTCL, and positivity for the CD4 receptor. - Late stage CTCL
Description

CTCL

Data type

boolean

Have received at least one prior anti-cancer therapy with inadequate effect
Description

Prior therapy

Data type

boolean

WHO performance status 0,1 or 2 - Male or female, age 18 or older. - Signed informed consent.
Description

Other

Data type

boolean

Exclusion
Description

Exclusion

Certain rare types of CTCL.
Description

Rare CTCL

Data type

boolean

Previous treatment with other anti-CD4 medications. - More than two previous treatments with systemic chemotherapy. - Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial. - Some types of steroid treatments less than two weeks before entering the trial
Description

Previous treatment

Data type

boolean

Prolonged exposure to sunlight or UV light during the trial. - Other cancer diseases, except certain skin cancers or cervix cancer. - Chronic infectious disease requiring medication. - Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases. - Certain laboratory values which are too high or too low. - HIV positivity
Description

Other

Data type

boolean

Pregnant or breast-feeding women. - Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
Description

Pregnancy - Lactation

Data type

boolean

If you are participating in another trial with a different new drug 4 weeks before you enter this trial
Description

other trial

Data type

boolean

Medical concepts
Description

Medical concepts

Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Lymphoma, T-Cell, Cutaneous
Description

CTCL

Data type

string

Alias
UMLS CUI
C0079773
SNOMED CT 2010_0731
28054005
Diagnostic Neoplasm Staging
Description

Tumor Staging

Data type

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Therapeutic procedure
Description

Therapeutic procedure

Data type

string

Alias
UMLS CUI
C0087111
WHO performance status finding
Description

WHO performance status finding

Data type

string

Alias
UMLS CUI
C1298651
SNOMED CT 2010_0731
373802001
Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Chemotherapy
Description

Chemotherapy

Data type

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Exposure to sunlight
Description

Exposure to sunlight

Data type

string

Alias
UMLS CUI
C0497062
ICD-10-CM Version 2010
X32
Infection
Description

Infection

Data type

string

Alias
UMLS CUI
C0021311
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
HIV negative
Description

HIV negative

Data type

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
MedDRA 13.1
10020179
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Contraception
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Enrollment
Description

Enrollment

Data type

string

Alias
UMLS CUI
C2348568
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion
CTCL
Item
Medical diagnosis of CTCL, and positivity for the CD4 receptor. - Late stage CTCL
boolean
Prior therapy
Item
Have received at least one prior anti-cancer therapy with inadequate effect
boolean
Other
Item
WHO performance status 0,1 or 2 - Male or female, age 18 or older. - Signed informed consent.
boolean
Item Group
Exclusion
Rare CTCL
Item
Certain rare types of CTCL.
boolean
Previous treatment
Item
Previous treatment with other anti-CD4 medications. - More than two previous treatments with systemic chemotherapy. - Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial. - Some types of steroid treatments less than two weeks before entering the trial
boolean
Other
Item
Prolonged exposure to sunlight or UV light during the trial. - Other cancer diseases, except certain skin cancers or cervix cancer. - Chronic infectious disease requiring medication. - Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases. - Certain laboratory values which are too high or too low. - HIV positivity
boolean
Pregnancy - Lactation
Item
Pregnant or breast-feeding women. - Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
boolean
other trial
Item
If you are participating in another trial with a different new drug 4 weeks before you enter this trial
boolean
Item Group
Medical concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
CTCL
Item
Lymphoma, T-Cell, Cutaneous
string
C0079773 (UMLS CUI)
28054005 (SNOMED CT 2010_0731)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
WHO performance status finding
Item
WHO performance status finding
string
C1298651 (UMLS CUI)
373802001 (SNOMED CT 2010_0731)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Exposure to sunlight
Item
Exposure to sunlight
string
C0497062 (UMLS CUI)
X32 (ICD-10-CM Version 2010)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI)
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