ID

15033

Beskrivning

Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides); ODM derived from: https://clinicaltrials.gov/show/NCT02448381

Länk

https://clinicaltrials.gov/show/NCT02448381

Nyckelord

Versioner (1)
  1. 2016-05-12 2016-05-12 -
Uppladdad den

12 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cutaneous T-Cell Lymphoma NCT02448381

Engelsk

Eligibility Cutaneous T-Cell Lymphoma NCT02448381

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have a clinical diagnosis of ctcl (mycosis fungoides), stage ia, stage ib, or stage iia.
Beskrivning

Lymphoma, T-Cell, Cutaneous | Mycosis Fungoides | Mycosis fungoides stage I | Mycosis fungoides stage II

Datatyp

boolean

Alias
UMLS CUI [1]
C0079773
UMLS CUI [2]
C0026948
UMLS CUI [3]
C0278567
UMLS CUI [4]
C0278569
subjects must have a minimum of three (3) evaluable, discrete lesions.
Beskrivning

Lesion Separate | Minimum Three

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0443299
UMLS CUI [2,1]
C1524031
UMLS CUI [2,2]
C0205449
subjects must be willing to refrain from sunbathing for the duration of the study.
Beskrivning

Willing Abstinence Sunbathing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C3843422
UMLS CUI [1,3]
C0038813
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, sjögren's syndrome, xeroderma pigmentosum, and melanoma, or polymorphous light or radiation therapy within 30 days of enrolling.
Beskrivning

Hypersensitivity Sunlight | Dermatitis, Phototoxic | Porphyria | Lupus Erythematosus, Systemic | Sjogren's Syndrome | Xeroderma Pigmentosum | Melanoma | Therapeutic procedure Polymorphous light eruption | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0038817
UMLS CUI [2]
C0162830
UMLS CUI [3]
C3463940
UMLS CUI [4]
C0024141
UMLS CUI [5]
C1527336
UMLS CUI [6]
C0043346
UMLS CUI [7]
C0025202
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C0031736
UMLS CUI [9]
C1522449
pregnancy or mothers who are breast feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
males and females not willing to use effective contraception.
Beskrivning

Unwilling Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0700589
unhealed sunburn.
Beskrivning

Sunburn Healed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038814
UMLS CUI [1,2]
C0205249
subjects receiving systemic or topical steroids, nitrogen mustard, psoralen uva radiation therapy (puva), or carmustine (bcnu) or other systemic therapies for ctcl within 3 weeks of enrollment.
Beskrivning

systemic steroids | Topical steroids | Mechlorethamine | PUVA Photochemotherapy | Carmustine | Systemic therapy Lymphoma, T-Cell, Cutaneous

Datatyp

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C2064827
UMLS CUI [3]
C0025033
UMLS CUI [4]
C0853073
UMLS CUI [5]
C0007257
UMLS CUI [6,1]
C1515119
UMLS CUI [6,2]
C0079773
subjects with significant history of systemic immunosuppression due to drugs or infection with hiv or htlv 1.
Beskrivning

Decreased Immunologic Activity Due to Pharmaceutical Preparations | Decreased Immunologic Activity Due to HIV Infections | Decreased Immunologic Activity Due to Human T-lymphotropic virus 1

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1373218
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C1373218
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0019693
UMLS CUI [3,1]
C1373218
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0020094
subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
Beskrivning

Investigational New Drugs Other | Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0013146
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Similar models

Eligibility Cutaneous T-Cell Lymphoma NCT02448381

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, T-Cell, Cutaneous | Mycosis Fungoides | Mycosis fungoides stage I | Mycosis fungoides stage II
Item
subjects must have a clinical diagnosis of ctcl (mycosis fungoides), stage ia, stage ib, or stage iia.
boolean
C0079773 (UMLS CUI [1])
C0026948 (UMLS CUI [2])
C0278567 (UMLS CUI [3])
C0278569 (UMLS CUI [4])
Lesion Separate | Minimum Three
Item
subjects must have a minimum of three (3) evaluable, discrete lesions.
boolean
C0221198 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C1524031 (UMLS CUI [2,1])
C0205449 (UMLS CUI [2,2])
Willing Abstinence Sunbathing
Item
subjects must be willing to refrain from sunbathing for the duration of the study.
boolean
C0600109 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C0038813 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Sunlight | Dermatitis, Phototoxic | Porphyria | Lupus Erythematosus, Systemic | Sjogren's Syndrome | Xeroderma Pigmentosum | Melanoma | Therapeutic procedure Polymorphous light eruption | Therapeutic radiology procedure
Item
history of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, sjögren's syndrome, xeroderma pigmentosum, and melanoma, or polymorphous light or radiation therapy within 30 days of enrolling.
boolean
C0020517 (UMLS CUI [1,1])
C0038817 (UMLS CUI [1,2])
C0162830 (UMLS CUI [2])
C3463940 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C1527336 (UMLS CUI [5])
C0043346 (UMLS CUI [6])
C0025202 (UMLS CUI [7])
C0087111 (UMLS CUI [8,1])
C0031736 (UMLS CUI [8,2])
C1522449 (UMLS CUI [9])
Pregnancy | Breast Feeding
Item
pregnancy or mothers who are breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Unwilling Contraceptive methods
Item
males and females not willing to use effective contraception.
boolean
C0558080 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Sunburn Healed
Item
unhealed sunburn.
boolean
C0038814 (UMLS CUI [1,1])
C0205249 (UMLS CUI [1,2])
systemic steroids | Topical steroids | Mechlorethamine | PUVA Photochemotherapy | Carmustine | Systemic therapy Lymphoma, T-Cell, Cutaneous
Item
subjects receiving systemic or topical steroids, nitrogen mustard, psoralen uva radiation therapy (puva), or carmustine (bcnu) or other systemic therapies for ctcl within 3 weeks of enrollment.
boolean
C2825233 (UMLS CUI [1])
C2064827 (UMLS CUI [2])
C0025033 (UMLS CUI [3])
C0853073 (UMLS CUI [4])
C0007257 (UMLS CUI [5])
C1515119 (UMLS CUI [6,1])
C0079773 (UMLS CUI [6,2])
Decreased Immunologic Activity Due to Pharmaceutical Preparations | Decreased Immunologic Activity Due to HIV Infections | Decreased Immunologic Activity Due to Human T-lymphotropic virus 1
Item
subjects with significant history of systemic immunosuppression due to drugs or infection with hiv or htlv 1.
boolean
C1373218 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1373218 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0019693 (UMLS CUI [2,3])
C1373218 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0020094 (UMLS CUI [3,3])
Investigational New Drugs Other | Drug abuse
Item
subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0013146 (UMLS CUI [2])
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