ID

38368

Description

Concurrent Chemoradiation + 5-FU + Mitomycin-C in Anal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01858025

Link

https://clinicaltrials.gov/show/NCT01858025

Keywords

  1. 10/13/19 10/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 13, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Carcinoma of the Anal Canal NCT01858025

Eligibility Carcinoma of the Anal Canal NCT01858025

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal
Description

Primary squamous cell carcinoma of anal canal Invasive | Basaloid carcinoma of anal canal Invasive | Cloacogenic carcinoma Invasive

Data type

boolean

Alias
UMLS CUI [1,1]
C4301960
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C2064239
UMLS CUI [2,2]
C0205281
UMLS CUI [3,1]
C0334273
UMLS CUI [3,2]
C0205281
life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior abdominopelvic radiotherapy
Description

Radiotherapy to abdomen | Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1997554
UMLS CUI [2]
C1536155
prior systemic therapy for anal cancer
Description

Systemic therapy Anal carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0279637
pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
receiving other investigational agents
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
history of allergic reactions attributed to compounds of similar chemical or biologic composition to mitomycin-c or 5-fluorouracil
Description

Allergic Reaction Compound Mitomycin Similar | Allergic Reaction Compound Fluorouracil Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0002475
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0016360
UMLS CUI [2,4]
C2348205
prior surgery for cancer of the anus that removed all macroscopic anal cancer
Description

Prior surgery Anal carcinoma | Anal carcinoma Macroscopic Removed

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0279637
UMLS CUI [2,1]
C0279637
UMLS CUI [2,2]
C0439806
UMLS CUI [2,3]
C0849355
uncontrolled intercurrent illness
Description

Comorbidity Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
aids based on current cdc definition
Description

AIDS

Data type

boolean

Alias
UMLS CUI [1]
C0001175
other immunocompromised status
Description

Immunocompromised patient

Data type

boolean

Alias
UMLS CUI [1]
C0085393
individuals with a history of a different malignancy are ineligible except for the following circumstances: disease-free for at least 5 years and at low risk for recurrence or cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
Description

Cancer Other | Exception Disease Free Duration | Exception Low Risk Recurrence | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3538919
UMLS CUI [3,3]
C0034897
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0553723

Similar models

Eligibility Carcinoma of the Anal Canal NCT01858025

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Primary squamous cell carcinoma of anal canal Invasive | Basaloid carcinoma of anal canal Invasive | Cloacogenic carcinoma Invasive
Item
histologically or cytologically confirmed invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal
boolean
C4301960 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C2064239 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
C0334273 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to abdomen | Radiotherapy to pelvis
Item
prior abdominopelvic radiotherapy
boolean
C1997554 (UMLS CUI [1])
C1536155 (UMLS CUI [2])
Systemic therapy Anal carcinoma
Item
prior systemic therapy for anal cancer
boolean
C1515119 (UMLS CUI [1,1])
C0279637 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
receiving other investigational agents
boolean
C0013230 (UMLS CUI [1])
Allergic Reaction Compound Mitomycin Similar | Allergic Reaction Compound Fluorouracil Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to mitomycin-c or 5-fluorouracil
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0002475 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0016360 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Prior surgery Anal carcinoma | Anal carcinoma Macroscopic Removed
Item
prior surgery for cancer of the anus that removed all macroscopic anal cancer
boolean
C0455610 (UMLS CUI [1,1])
C0279637 (UMLS CUI [1,2])
C0279637 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C0849355 (UMLS CUI [2,3])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
AIDS
Item
aids based on current cdc definition
boolean
C0001175 (UMLS CUI [1])
Immunocompromised patient
Item
other immunocompromised status
boolean
C0085393 (UMLS CUI [1])
Cancer Other | Exception Disease Free Duration | Exception Low Risk Recurrence | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
individuals with a history of a different malignancy are ineligible except for the following circumstances: disease-free for at least 5 years and at low risk for recurrence or cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0034897 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0553723 (UMLS CUI [6,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial