ID

27435

Beskrivning

CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00847912

Länk

https://clinicaltrials.gov/show/NCT00847912

Nyckelord

Versioner (2)
  1. 2017-11-11 2017-11-11 -
  2. 2017-11-14 2017-11-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Basal Cell NCT00847912

Engelsk

Eligibility Carcinoma, Basal Cell NCT00847912

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
veteran who is at high risk for developing skin cancer defined as 2 keratinocyte carcinomas in the past 5 years, at least one of which was located on the face or ears
Beskrivning

Veteran | Malignant neoplasm of skin High risk | Keratinocyte Carcinoma Quantity | Keratinocyte Carcinoma Face | Keratinocyte Carcinoma Ear

Datatyp

boolean

Alias
UMLS CUI [1]
C0042610
UMLS CUI [2,1]
C0007114
UMLS CUI [2,2]
C0332167
UMLS CUI [3,1]
C0022567
UMLS CUI [3,2]
C0007097
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0022567
UMLS CUI [4,2]
C0007097
UMLS CUI [4,3]
C0015450
UMLS CUI [5,1]
C0022567
UMLS CUI [5,2]
C0007097
UMLS CUI [5,3]
C0521421
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who are unable to speak english
Beskrivning

Lacking Able to speak English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
participants with kc at randomization
Beskrivning

Keratinocyte Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022567
UMLS CUI [1,2]
C0007097
participants currently using or having used field therapy for aks on the face or ears in the past 3 years. the vast majority of these field treatments would have been with 5-fu cream. we will allow recent use of therapies that are applied to individual ak lesions (e.g. cryotherapy), but not those that were used on an entire area (field) in the study treatment area participants currently using or having used systemic 5-fluorouracil or oral capecitabine (xeloda) within the past 3 years participants with known allergy to sunscreen, triamcinolone and/or 5-fluorouracil.
Beskrivning

Field therapy Actinic keratosis Face | Field therapy Actinic keratosis Ear | Fluorouracil Cream | Cold Therapy Actinic keratosis Lesion | Fluorouracil, Systemic | Capecitabine Oral Product | Xeloda Oral Product | Hypersensitivity Sunscreening Agents | Triamcinolone allergy | Fluorouracil allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205146
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0022602
UMLS CUI [1,4]
C0015450
UMLS CUI [2,1]
C0205146
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0022602
UMLS CUI [2,4]
C0521421
UMLS CUI [3,1]
C0016360
UMLS CUI [3,2]
C1378128
UMLS CUI [4,1]
C0010412
UMLS CUI [4,2]
C0022602
UMLS CUI [4,3]
C0221198
UMLS CUI [5]
C0720482
UMLS CUI [6]
C3213270
UMLS CUI [7]
C3240162
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0038818
UMLS CUI [9]
C0571619
UMLS CUI [10]
C0570698
exclusions 6-l0: we will exclude the small proportion who get their kcs for special reasons other than ultraviolet radiation exposure (see list below), since that etiologic difference, which is associated with a prognostic difference, could be associated with a biologic difference in response to chemoprevention efforts. these will include:
Beskrivning

Keratinocyte Carcinoma Due to Causes Special | Exception Exposure to Ultraviolet Rays

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022567
UMLS CUI [1,2]
C0007097
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0015127
UMLS CUI [1,5]
C0205555
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0041625
solid organ transplant recipients, such as renal, hepatic, or cardiac transplant patients
Beskrivning

Solid organ transplant Recipient | Kidney Transplantation | Transplantation of liver | Heart Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0730400
UMLS CUI [1,2]
C1709854
UMLS CUI [2]
C0022671
UMLS CUI [3]
C0023911
UMLS CUI [4]
C0018823
individuals with genetic disorders associated with very high cancer risk such as:
Beskrivning

Genetic Diseases Associated with Heightened Cancer Risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019247
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1512362
basal cell nevus syndrome
Beskrivning

Basal Cell Nevus Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0004779
erythrodysplasia verruciformis
Beskrivning

Erythrodysplasia | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C2987488
UMLS CUI [2]
C3846158
xeroderma pigmentosum
Beskrivning

Xeroderma Pigmentosum

Datatyp

boolean

Alias
UMLS CUI [1]
C0043346
arsenic exposure
Beskrivning

arsenic exposure

Datatyp

boolean

Alias
UMLS CUI [1]
C0238690
puva (psoralen plus uva) treatment
Beskrivning

PUVA

Datatyp

boolean

Alias
UMLS CUI [1]
C0853073
cutaneous t-cell lymphoma
Beskrivning

Lymphoma, T-Cell, Cutaneous

Datatyp

boolean

Alias
UMLS CUI [1]
C0079773
prior or current radiation therapy to the face and/or ears.
Beskrivning

Therapeutic radiology procedure Face | Radiotherapy to ear

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0015450
UMLS CUI [2]
C0948311
additional exclusions (12-15) are:
Beskrivning

Exclusion Criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
those who, in the opinion of the recruiting investigator, have very high mortality risk at randomization (less than 50% chance of surviving 4 years) due to co morbid illness such as metastatic cancer or copd.
Beskrivning

Mortality High risk Very | Life Expectancy | Comorbidity | Neoplasm Metastasis | COPD

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026566
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0442824
UMLS CUI [2]
C0023671
UMLS CUI [3]
C0009488
UMLS CUI [4]
C0027627
UMLS CUI [5]
C0024117
for women of childbearing potential an initial pregnancy test and ongoing birth control will be required for participation.
Beskrivning

Childbearing Potential Pregnancy Test Initial | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0205265
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
patients with known dihydropyrimidine dehydrogenase (dpd) enzyme deficiency by self report or noted in the medical record (they have increased toxicity from systemic 5-fu, although screening for this is not part of dermatologic practice and will not be part of this study).
Beskrivning

Dihydropyrimidine Dehydrogenase Deficiency | Toxicity Increased Due to Systemic Fluorouracil

Datatyp

boolean

Alias
UMLS CUI [1]
C1959620
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0205217
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0720482
patients on methotrexate (these will constitute about 1% of potentially eligible individuals) because they may have more severe reactions to topical 5-fu.
Beskrivning

Methotrexate | Severe reaction 5-FU Topical

Datatyp

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2,1]
C3242604
UMLS CUI [2,2]
C0016360
UMLS CUI [2,3]
C1710439
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Similar models

Eligibility Carcinoma, Basal Cell NCT00847912

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Veteran | Malignant neoplasm of skin High risk | Keratinocyte Carcinoma Quantity | Keratinocyte Carcinoma Face | Keratinocyte Carcinoma Ear
Item
veteran who is at high risk for developing skin cancer defined as 2 keratinocyte carcinomas in the past 5 years, at least one of which was located on the face or ears
boolean
C0042610 (UMLS CUI [1])
C0007114 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0022567 (UMLS CUI [3,1])
C0007097 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0022567 (UMLS CUI [4,1])
C0007097 (UMLS CUI [4,2])
C0015450 (UMLS CUI [4,3])
C0022567 (UMLS CUI [5,1])
C0007097 (UMLS CUI [5,2])
C0521421 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Lacking Able to speak English Language
Item
participants who are unable to speak english
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Keratinocyte Carcinoma
Item
participants with kc at randomization
boolean
C0022567 (UMLS CUI [1,1])
C0007097 (UMLS CUI [1,2])
Field therapy Actinic keratosis Face | Field therapy Actinic keratosis Ear | Fluorouracil Cream | Cold Therapy Actinic keratosis Lesion | Fluorouracil, Systemic | Capecitabine Oral Product | Xeloda Oral Product | Hypersensitivity Sunscreening Agents | Triamcinolone allergy | Fluorouracil allergy
Item
participants currently using or having used field therapy for aks on the face or ears in the past 3 years. the vast majority of these field treatments would have been with 5-fu cream. we will allow recent use of therapies that are applied to individual ak lesions (e.g. cryotherapy), but not those that were used on an entire area (field) in the study treatment area participants currently using or having used systemic 5-fluorouracil or oral capecitabine (xeloda) within the past 3 years participants with known allergy to sunscreen, triamcinolone and/or 5-fluorouracil.
boolean
C0205146 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0022602 (UMLS CUI [1,3])
C0015450 (UMLS CUI [1,4])
C0205146 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0022602 (UMLS CUI [2,3])
C0521421 (UMLS CUI [2,4])
C0016360 (UMLS CUI [3,1])
C1378128 (UMLS CUI [3,2])
C0010412 (UMLS CUI [4,1])
C0022602 (UMLS CUI [4,2])
C0221198 (UMLS CUI [4,3])
C0720482 (UMLS CUI [5])
C3213270 (UMLS CUI [6])
C3240162 (UMLS CUI [7])
C0020517 (UMLS CUI [8,1])
C0038818 (UMLS CUI [8,2])
C0571619 (UMLS CUI [9])
C0570698 (UMLS CUI [10])
Keratinocyte Carcinoma Due to Causes Special | Exception Exposure to Ultraviolet Rays
Item
exclusions 6-l0: we will exclude the small proportion who get their kcs for special reasons other than ultraviolet radiation exposure (see list below), since that etiologic difference, which is associated with a prognostic difference, could be associated with a biologic difference in response to chemoprevention efforts. these will include:
boolean
C0022567 (UMLS CUI [1,1])
C0007097 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0205555 (UMLS CUI [1,5])
C1705847 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0041625 (UMLS CUI [2,3])
Solid organ transplant Recipient | Kidney Transplantation | Transplantation of liver | Heart Transplantation
Item
solid organ transplant recipients, such as renal, hepatic, or cardiac transplant patients
boolean
C0730400 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0022671 (UMLS CUI [2])
C0023911 (UMLS CUI [3])
C0018823 (UMLS CUI [4])
Genetic Diseases Associated with Heightened Cancer Risk
Item
individuals with genetic disorders associated with very high cancer risk such as:
boolean
C0019247 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1512362 (UMLS CUI [1,3])
Basal Cell Nevus Syndrome
Item
basal cell nevus syndrome
boolean
C0004779 (UMLS CUI [1])
Erythrodysplasia | Other Coding
Item
erythrodysplasia verruciformis
boolean
C2987488 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Xeroderma Pigmentosum
Item
xeroderma pigmentosum
boolean
C0043346 (UMLS CUI [1])
arsenic exposure
Item
arsenic exposure
boolean
C0238690 (UMLS CUI [1])
PUVA
Item
puva (psoralen plus uva) treatment
boolean
C0853073 (UMLS CUI [1])
Lymphoma, T-Cell, Cutaneous
Item
cutaneous t-cell lymphoma
boolean
C0079773 (UMLS CUI [1])
Therapeutic radiology procedure Face | Radiotherapy to ear
Item
prior or current radiation therapy to the face and/or ears.
boolean
C1522449 (UMLS CUI [1,1])
C0015450 (UMLS CUI [1,2])
C0948311 (UMLS CUI [2])
Exclusion Criteria Additional
Item
additional exclusions (12-15) are:
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Mortality High risk Very | Life Expectancy | Comorbidity | Neoplasm Metastasis | COPD
Item
those who, in the opinion of the recruiting investigator, have very high mortality risk at randomization (less than 50% chance of surviving 4 years) due to co morbid illness such as metastatic cancer or copd.
boolean
C0026566 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0442824 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
C0024117 (UMLS CUI [5])
Childbearing Potential Pregnancy Test Initial | Childbearing Potential Contraceptive methods
Item
for women of childbearing potential an initial pregnancy test and ongoing birth control will be required for participation.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Dihydropyrimidine Dehydrogenase Deficiency | Toxicity Increased Due to Systemic Fluorouracil
Item
patients with known dihydropyrimidine dehydrogenase (dpd) enzyme deficiency by self report or noted in the medical record (they have increased toxicity from systemic 5-fu, although screening for this is not part of dermatologic practice and will not be part of this study).
boolean
C1959620 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0720482 (UMLS CUI [2,4])
Methotrexate | Severe reaction 5-FU Topical
Item
patients on methotrexate (these will constitute about 1% of potentially eligible individuals) because they may have more severe reactions to topical 5-fu.
boolean
C0025677 (UMLS CUI [1])
C3242604 (UMLS CUI [2,1])
C0016360 (UMLS CUI [2,2])
C1710439 (UMLS CUI [2,3])
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