ID

39604

Description

Photodynamic Therapy Using HPPH in Treating Patients With Recurrent Dysplasia, Carcinoma in Situ, or Stage I Oral Cavity Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00670397

Link

https://clinicaltrials.gov/show/NCT00670397

Keywords

Versions (1)
  1. 2/2/20 2/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 2, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Head and Neck Cancer NCT00670397

English

Eligibility Head and Neck Cancer NCT00670397

1 forms  
Criteria
Description

Criteria

biopsy-confirmed diagnosis of 1 of the following:
Description

Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0005558
mild to severe dysplasia
Description

Mild dysplasia | Severe dysplasia

Data type

boolean

Alias
UMLS CUI [1]
C0334046
UMLS CUI [2]
C0334048
carcinoma in situ (cis) of the oral cavity
Description

Carcinoma in situ of mouth

Data type

boolean

Alias
UMLS CUI [1,1]
C0347073
UMLS CUI [1,2]
C3258246
carcinoma must be less than 3mm thick
Description

Carcinoma Thickness

Data type

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C1280412
stage i (t1) squamous cell carcinoma of the oral cavity
Description

Squamous cell carcinoma of mouth TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0585362
UMLS CUI [1,2]
C3258246
recurrent or primary disease
Description

Recurrent disease | Primary disorder

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0277554
no t2 or greater squamous cell carcinoma, exophytic cis, or dysplasia lesions
Description

Squamous cell carcinoma TNM clinical staging | Carcinoma in Situ Exophytic Absent | Dysplasia Lesion Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0007137
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007099
UMLS CUI [2,2]
C2700034
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0334044
UMLS CUI [3,2]
C0221198
UMLS CUI [3,3]
C0332197
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
total bilirubin ≤ 2.0 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
creatinine ≤ 2.0 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
alkaline phosphatase ≤ 3 times the upper limit of normal (uln)
Description

Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201850
sgot ≤ 3 times uln
Description

Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
not pregnant
Description

Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
Description

Porphyria Absent | Hypersensitivity Absent Porphyrin | Hypersensitivity Absent Compound Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C3463940
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0032712
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C1706082
UMLS CUI [3,4]
C2348205
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
prior therapy of any type allowed
Description

Prior Therapy Type Any

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
more than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Description

Chemotherapy Absent | Therapeutic radiology procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
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Similar models

Eligibility Head and Neck Cancer NCT00670397

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Biopsy
Item
biopsy-confirmed diagnosis of 1 of the following:
boolean
C0005558 (UMLS CUI [1])
Mild dysplasia | Severe dysplasia
Item
mild to severe dysplasia
boolean
C0334046 (UMLS CUI [1])
C0334048 (UMLS CUI [2])
Carcinoma in situ of mouth
Item
carcinoma in situ (cis) of the oral cavity
boolean
C0347073 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Carcinoma Thickness
Item
carcinoma must be less than 3mm thick
boolean
C0007097 (UMLS CUI [1,1])
C1280412 (UMLS CUI [1,2])
Squamous cell carcinoma of mouth TNM clinical staging
Item
stage i (t1) squamous cell carcinoma of the oral cavity
boolean
C0585362 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Recurrent disease | Primary disorder
Item
recurrent or primary disease
boolean
C0277556 (UMLS CUI [1])
C0277554 (UMLS CUI [2])
Squamous cell carcinoma TNM clinical staging | Carcinoma in Situ Exophytic Absent | Dysplasia Lesion Absent
Item
no t2 or greater squamous cell carcinoma, exophytic cis, or dysplasia lesions
boolean
C0007137 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007099 (UMLS CUI [2,1])
C2700034 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0334044 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤ 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase ≤ 3 times the upper limit of normal (uln)
boolean
C0201850 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
sgot ≤ 3 times uln
boolean
C0201899 (UMLS CUI [1])
Pregnancy Absent
Item
not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Porphyria Absent | Hypersensitivity Absent Porphyrin | Hypersensitivity Absent Compound Similar
Item
no porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
boolean
C3463940 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032712 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1706082 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Prior Therapy Type Any
Item
prior therapy of any type allowed
boolean
C1514463 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
more than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
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