ID

35846

Description

KeraStat Skin Therapy in Treating Radiation Dermatitis in Patients With Newly Diagnosed Stage 0-IIIA Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02168179

Link

https://clinicaltrials.gov/show/NCT02168179

Keywords

Versions (1)
  1. 3/26/19 3/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 26, 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.

Back to model comments
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 Ductal Breast Carcinoma in Situ NCT02168179

English

Eligibility Ductal Breast Carcinoma in Situ NCT02168179

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed with breast carcinoma, stage 0-iiia (including ductal carcinoma in situ [dcis])
Description

Breast Carcinoma TNM Breast tumor staging | DCIS

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0007124
status post-lumpectomy, -quadrantectomy, or -mastectomy
Description

Status post Segmental Mastectomy | Status post Quadrantectomy of breast | Status post Mastectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0024885
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0337354
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0024881
plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes
Description

Whole Breast Irradiation Adjuvant Planned | Irradiation of chest wall Adjuvant Planned | Irradiation of lymph nodes regional Planned | Irradiation of lymph nodes regional Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3897169
UMLS CUI [1,2]
C1522673
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C2064934
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C2169077
UMLS CUI [3,2]
C0205147
UMLS CUI [3,3]
C1301732
UMLS CUI [4,1]
C2169077
UMLS CUI [4,2]
C0205147
UMLS CUI [4,3]
C0332197
total dose >= 40gy
Description

Cumulative Dose

Data type

boolean

Alias
UMLS CUI [1]
C2986497
dose per fraction >= 1.8 use of 2-dimensional (2d), 3-dimensional (3d) conformal, or intensity-modulated radiation therapy (imrt) treatment techniques allowed; skin sparing imrt patients excluded; a daily fraction of 2.7 gy to the whole breast is suggested for hypofractionated regimens
Description

Conformal Radiotherapy 2-Dimensional Dose Fractionation | Conformal Radiotherapy Three-dimensional Dose Fractionation | Intensity-Modulated Radiotherapy Dose Fractionation | Hypofractionated radiation therapy Whole breast Dose Fractionation

Data type

boolean

Alias
UMLS CUI [1,1]
C0600521
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C0524811
UMLS CUI [2,1]
C0600521
UMLS CUI [2,2]
C0450363
UMLS CUI [2,3]
C0524811
UMLS CUI [3,1]
C1512814
UMLS CUI [3,2]
C0524811
UMLS CUI [4,1]
C1831786
UMLS CUI [4,2]
C0457102
UMLS CUI [4,3]
C0524811
concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
Description

Boost radiation therapy With Standard therapy | Boost radiation therapy With Hypofractionated radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2919491
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C2936643
UMLS CUI [2,1]
C2919491
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C1831786
adjuvant hormonal therapy will be allowed prior to, during and/or after rt at the discretion of a medical oncologist
Description

Hormone Therapy Adjuvant | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
UMLS CUI [2]
C1522449
targeted therapies such as herceptin will be allowed prior to, during, and/or after rt at the discretion of the medical oncologist
Description

Targeted Therapy | Herceptin | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C2985566
UMLS CUI [2]
C0338204
UMLS CUI [3]
C1522449
patients who are able and willing to sign protocol consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior radiation to the involved breast or chest wall
Description

Prior radiation therapy Breast Involved | Prior radiation therapy Chest wall Involved

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C1314939
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0205076
UMLS CUI [2,3]
C1314939
concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion)
Description

Chemotherapy Concurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205420
patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed)
Description

Mammaplasty Following Mastectomy | Insertion of tissue expander | Breast implants

Data type

boolean

Alias
UMLS CUI [1,1]
C0085076
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0024881
UMLS CUI [2]
C0184968
UMLS CUI [3]
C0179412
patients undergoing partial breast irradiation
Description

Irradiation of breast Partial

Data type

boolean

Alias
UMLS CUI [1,1]
C2148528
UMLS CUI [1,2]
C0728938
patients who have undergone mammosite® or any other form of brachytherapy
Description

Balloon brachytherapy | Brachytherapy

Data type

boolean

Alias
UMLS CUI [1]
C1832047
UMLS CUI [2]
C0006098
patients may not be concurrently enrolled in a protocol that involves treatment of the skin ie: applying lotions /moisturizers; protocols that do not involve treatment of the skin are allowed
Description

Study Subject Participation Status | Skin-Directed Therapy | Skin Therapy, topical lotion | Application of moisturizer to skin

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C4054014
UMLS CUI [3]
C1814439
UMLS CUI [4]
C0455079
patients who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Back to the top of the page

Similar models

Eligibility Ductal Breast Carcinoma in Situ NCT02168179

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | DCIS
Item
newly diagnosed with breast carcinoma, stage 0-iiia (including ductal carcinoma in situ [dcis])
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
Status post Segmental Mastectomy | Status post Quadrantectomy of breast | Status post Mastectomy
Item
status post-lumpectomy, -quadrantectomy, or -mastectomy
boolean
C0231290 (UMLS CUI [1,1])
C0024885 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0337354 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0024881 (UMLS CUI [3,2])
Whole Breast Irradiation Adjuvant Planned | Irradiation of chest wall Adjuvant Planned | Irradiation of lymph nodes regional Planned | Irradiation of lymph nodes regional Absent
Item
plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes
boolean
C3897169 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C2064934 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C2169077 (UMLS CUI [3,1])
C0205147 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
C2169077 (UMLS CUI [4,1])
C0205147 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Cumulative Dose
Item
total dose >= 40gy
boolean
C2986497 (UMLS CUI [1])
Conformal Radiotherapy 2-Dimensional Dose Fractionation | Conformal Radiotherapy Three-dimensional Dose Fractionation | Intensity-Modulated Radiotherapy Dose Fractionation | Hypofractionated radiation therapy Whole breast Dose Fractionation
Item
dose per fraction >= 1.8 use of 2-dimensional (2d), 3-dimensional (3d) conformal, or intensity-modulated radiation therapy (imrt) treatment techniques allowed; skin sparing imrt patients excluded; a daily fraction of 2.7 gy to the whole breast is suggested for hypofractionated regimens
boolean
C0600521 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0524811 (UMLS CUI [1,3])
C0600521 (UMLS CUI [2,1])
C0450363 (UMLS CUI [2,2])
C0524811 (UMLS CUI [2,3])
C1512814 (UMLS CUI [3,1])
C0524811 (UMLS CUI [3,2])
C1831786 (UMLS CUI [4,1])
C0457102 (UMLS CUI [4,2])
C0524811 (UMLS CUI [4,3])
Boost radiation therapy With Standard therapy | Boost radiation therapy With Hypofractionated radiation therapy
Item
concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
boolean
C2919491 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C2936643 (UMLS CUI [1,3])
C2919491 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C1831786 (UMLS CUI [2,3])
Hormone Therapy Adjuvant | Therapeutic radiology procedure
Item
adjuvant hormonal therapy will be allowed prior to, during and/or after rt at the discretion of a medical oncologist
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
Targeted Therapy | Herceptin | Therapeutic radiology procedure
Item
targeted therapies such as herceptin will be allowed prior to, during, and/or after rt at the discretion of the medical oncologist
boolean
C2985566 (UMLS CUI [1])
C0338204 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Informed Consent
Item
patients who are able and willing to sign protocol consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior radiation therapy Breast Involved | Prior radiation therapy Chest wall Involved
Item
prior radiation to the involved breast or chest wall
boolean
C0279134 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0205076 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
Chemotherapy Concurrent
Item
concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion)
boolean
C0392920 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Mammaplasty Following Mastectomy | Insertion of tissue expander | Breast implants
Item
patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed)
boolean
C0085076 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0024881 (UMLS CUI [1,3])
C0184968 (UMLS CUI [2])
C0179412 (UMLS CUI [3])
Irradiation of breast Partial
Item
patients undergoing partial breast irradiation
boolean
C2148528 (UMLS CUI [1,1])
C0728938 (UMLS CUI [1,2])
Balloon brachytherapy | Brachytherapy
Item
patients who have undergone mammosite® or any other form of brachytherapy
boolean
C1832047 (UMLS CUI [1])
C0006098 (UMLS CUI [2])
Study Subject Participation Status | Skin-Directed Therapy | Skin Therapy, topical lotion | Application of moisturizer to skin
Item
patients may not be concurrently enrolled in a protocol that involves treatment of the skin ie: applying lotions /moisturizers; protocols that do not involve treatment of the skin are allowed
boolean
C2348568 (UMLS CUI [1])
C4054014 (UMLS CUI [2])
C1814439 (UMLS CUI [3])
C0455079 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
patients who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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