ID

39126

Description

A Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx; ODM derived from: https://clinicaltrials.gov/show/NCT01140178

Link

https://clinicaltrials.gov/show/NCT01140178

Keywords

Versions (1)
  1. 12/3/19 12/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Dysplasia NCT01140178

English

Eligibility Dysplasia NCT01140178

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Dysplasia NCT01140178
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with moderate to severe dysplasia and/or squamous carcinoma-in-situ of the oral cavity and/or oropharynx.
Description

Moderate dysplasia | Severe dysplasia | Squamous cell carcinoma in situ of oral cavity | Squamous cell carcinoma in situ of oropharynx

Data type

boolean

Alias
UMLS CUI [1]
C0334047
UMLS CUI [2]
C0334048
UMLS CUI [3]
C4317014
UMLS CUI [4]
C4317015
patients with t1 squamous cell carcinoma of the oral cavity and/or oropharynx.
Description

Squamous cell carcinoma of mouth TNM clinical staging | Squamous cell carcinoma of oropharynx TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0585362
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0280313
UMLS CUI [2,2]
C3258246
patient may have primary and/or recurrent lesions to be treated.
Description

Primary Lesion Treatment required for | Lesion Recurrent Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C1402294
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C2945760
UMLS CUI [2,3]
C0332121
diagnosis must confirmed by biopsy.
Description

Diagnosis Confirmed by Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C0005558
prior therapy of any type is allowed.
Description

Prior Therapy allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0683607
male or female patients at least 18 years old. female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal. male patients should be using a medically acceptable form of birth control or be sterile.
Description

Age | Gender Pregnancy Absent | Gender Contraceptive methods | Female Sterilization | Postmenopausal state | Gender Contraceptive methods | Male sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0232970
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0700589
UMLS CUI [7]
C0024559
patients must have an ecog score of 0-2 (appendix a 1 ).
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patient or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure.
Description

Comprehension Study Protocol | Comprehension Study Protocol Patient Representative | Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0030701
UMLS CUI [3]
C0021430
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with t2 or greater squamous cell carcinoma.
Description

Squamous cell carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007137
UMLS CUI [1,2]
C3258246
true tongue base lesions (as determined by the treating physician).
Description

Lesion Base of tongue

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1284376
patients with severe trismus that prevents adequate access to the lesion for treatment light delivery (as determined by the treating physician).
Description

Trismus Severe | Access Lacking Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0041105
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C0221198
porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
Description

Porphyria | Hypersensitivity Porphyrin | Hypersensitivity Pharmaceutical Preparations Porphyrin Similar

Data type

boolean

Alias
UMLS CUI [1]
C3463940
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0032712
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0032712
UMLS CUI [3,4]
C2348205
patients with impaired hepatic (alkaline phosphatase (hepatic) or sgot;:3 times the upper normal limits).
Description

Liver Dysfunction | Alkaline phosphatase raised | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151849
UMLS CUI [3]
C0151904
patients with minimal impairment of renal function (total serum bilirubin;: 2 mg/dl, serum creatinine;: 2 mg/dl)
Description

Renal Insufficiency Minimal | Serum total bilirubin measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0547040
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201976
unwilling or unable to follow protocol requirements.
Description

Protocol Compliance Unwilling | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug and or light treatment.
Description

Condition Study Subject Participation Status Inappropriate | Patient Inappropriate Investigational New Drugs | Patient Inappropriate Investigational therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0949266
patients on concurrent chemotherapy or radiation therapy or less than 4 weeks after the last dose of chemotherapy or radiation therapy.
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
inclusion of women and minorities:
Description

Inclusion criteria | Gender | Minorities

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0026192
both men and women and members of all races and ethnic groups are eligible for this study.
Description

Gender Both Eligible | Racial group All Eligible | Ethnic group All Eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1706086
UMLS CUI [1,3]
C1548635
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C0444868
UMLS CUI [2,3]
C1548635
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C0444868
UMLS CUI [3,3]
C1548635
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Similar models

Eligibility Dysplasia NCT01140178

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Dysplasia NCT01140178
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Moderate dysplasia | Severe dysplasia | Squamous cell carcinoma in situ of oral cavity | Squamous cell carcinoma in situ of oropharynx
Item
patients with moderate to severe dysplasia and/or squamous carcinoma-in-situ of the oral cavity and/or oropharynx.
boolean
C0334047 (UMLS CUI [1])
C0334048 (UMLS CUI [2])
C4317014 (UMLS CUI [3])
C4317015 (UMLS CUI [4])
Squamous cell carcinoma of mouth TNM clinical staging | Squamous cell carcinoma of oropharynx TNM clinical staging
Item
patients with t1 squamous cell carcinoma of the oral cavity and/or oropharynx.
boolean
C0585362 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0280313 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Primary Lesion Treatment required for | Lesion Recurrent Treatment required for
Item
patient may have primary and/or recurrent lesions to be treated.
boolean
C1402294 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0332121 (UMLS CUI [2,3])
Diagnosis Confirmed by Biopsy
Item
diagnosis must confirmed by biopsy.
boolean
C0011900 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Prior Therapy allowed
Item
prior therapy of any type is allowed.
boolean
C1514463 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
Age | Gender Pregnancy Absent | Gender Contraceptive methods | Female Sterilization | Postmenopausal state | Gender Contraceptive methods | Male sterilization
Item
male or female patients at least 18 years old. female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal. male patients should be using a medically acceptable form of birth control or be sterile.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0024559 (UMLS CUI [7])
ECOG performance status
Item
patients must have an ecog score of 0-2 (appendix a 1 ).
boolean
C1520224 (UMLS CUI [1])
Comprehension Study Protocol | Comprehension Study Protocol Patient Representative | Informed Consent | Informed Consent Patient Representative
Item
patient or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0030701 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Squamous cell carcinoma TNM clinical staging
Item
patients with t2 or greater squamous cell carcinoma.
boolean
C0007137 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Lesion Base of tongue
Item
true tongue base lesions (as determined by the treating physician).
boolean
C0221198 (UMLS CUI [1,1])
C1284376 (UMLS CUI [1,2])
Trismus Severe | Access Lacking Lesion
Item
patients with severe trismus that prevents adequate access to the lesion for treatment light delivery (as determined by the treating physician).
boolean
C0041105 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
Porphyria | Hypersensitivity Porphyrin | Hypersensitivity Pharmaceutical Preparations Porphyrin Similar
Item
porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
boolean
C3463940 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0032712 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0032712 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
Liver Dysfunction | Alkaline phosphatase raised | Aspartate aminotransferase increased
Item
patients with impaired hepatic (alkaline phosphatase (hepatic) or sgot;:3 times the upper normal limits).
boolean
C0086565 (UMLS CUI [1])
C0151849 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency Minimal | Serum total bilirubin measurement | Creatinine measurement, serum
Item
patients with minimal impairment of renal function (total serum bilirubin;: 2 mg/dl, serum creatinine;: 2 mg/dl)
boolean
C1565489 (UMLS CUI [1,1])
C0547040 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
unwilling or unable to follow protocol requirements.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Condition Study Subject Participation Status Inappropriate | Patient Inappropriate Investigational New Drugs | Patient Inappropriate Investigational therapy
Item
any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug and or light treatment.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0949266 (UMLS CUI [3,3])
Chemotherapy | Therapeutic radiology procedure
Item
patients on concurrent chemotherapy or radiation therapy or less than 4 weeks after the last dose of chemotherapy or radiation therapy.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Inclusion criteria | Gender | Minorities
Item
inclusion of women and minorities:
boolean
C1512693 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0026192 (UMLS CUI [3])
Gender Both Eligible | Racial group All Eligible | Ethnic group All Eligible
Item
both men and women and members of all races and ethnic groups are eligible for this study.
boolean
C0079399 (UMLS CUI [1,1])
C1706086 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C0034510 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C1548635 (UMLS CUI [2,3])
C0015031 (UMLS CUI [3,1])
C0444868 (UMLS CUI [3,2])
C1548635 (UMLS CUI [3,3])
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