ID

35846

Descripción

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

Palabras clave

Versiones (1)
  1. 26/3/19 26/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

26 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Ductal Breast Carcinoma in Situ NCT02168179

Inglés

Eligibility Ductal Breast Carcinoma in Situ NCT02168179

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Breast Carcinoma TNM Breast tumor staging | DCIS

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Cumulative Dose

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Hormone Therapy Adjuvant | Therapeutic radiology procedure

Tipo de datos

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
Descripción

Targeted Therapy | Herceptin | Therapeutic radiology procedure

Tipo de datos

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
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

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

Tipo de datos

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)
Descripción

Chemotherapy Concurrent

Tipo de datos

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)
Descripción

Mammaplasty Following Mastectomy | Insertion of tissue expander | Breast implants

Tipo de datos

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
Descripción

Irradiation of breast Partial

Tipo de datos

boolean

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

Balloon brachytherapy | Brachytherapy

Tipo de datos

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
Descripción

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

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Ductal Breast Carcinoma in Situ NCT02168179

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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