ID

37997

Beskrivning

Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01407770

Länk

https://clinicaltrials.gov/show/NCT01407770

Nyckelord

Versioner (1)
  1. 2019-09-06 2019-09-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 september 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01407770

Engelsk

Eligibility Breast Cancer NCT01407770

1 Formulär  
Criteria
Beskrivning

Criteria

female patients newly diagnosed with breast carcinoma including ductal carcinoma in situ (dcis)
Beskrivning

Gender | Breast Carcinoma | DCIS

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0007124
stage 0-iiia disease
Beskrivning

Disease TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
status post-lumpectomy, -quadrantectomy, or -mastectomy
Beskrivning

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

Datatyp

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 and/or regional lymph nodes
Beskrivning

Whole Breast Irradiation Adjuvant Planned | Irradiation of chest wall Adjuvant Planned | Irradiation of lymph nodes Regional Adjuvant Planned

Datatyp

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]
C1522673
UMLS CUI [3,4]
C1301732
no sites that cannot send blood/urine specimens to wake forest by overnight (next day) express shipping
Beskrivning

Exclusion Criteria | Blood specimen Unavailable | Urine specimen Unavailable

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0178913
UMLS CUI [2,2]
C0686905
UMLS CUI [3,1]
C1610733
UMLS CUI [3,2]
C0686905
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
*this stratum is closed as of april 25, 2012.
Beskrivning

ID.7

Datatyp

boolean

no patients who do not understand english and are unable to complete form with assistance
Beskrivning

Exclusion Criteria | Comprehension English Language Unable | Consent Form Completion Assisted Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0009797
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C1269765
UMLS CUI [3,4]
C1299582
prior concurrent therapy:
Beskrivning

Prior Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
total dose > 40 gy, dose per fraction > 1.8 - 2.0 gy, use of 2d, 3d-conformal, or intensity-modulated radiation therapy (imrt) treatment techniques allowed; a daily fraction of 2.7 gy to the whole breast is suggested for hypofractionated regimens
Beskrivning

Therapeutic radiology procedure Cumulative Dose | Therapeutic radiology procedure Dose Fractionated | Therapeutic radiology procedure 2-Dimensional | Radiotherapy, Conformal | Radiotherapy, Intensity-Modulated | Hypofractionated radiation therapy Whole breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C2986497
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1979893
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C1705052
UMLS CUI [4]
C0600521
UMLS CUI [5]
C1512814
UMLS CUI [6,1]
C1831786
UMLS CUI [6,2]
C0457102
concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
Beskrivning

Boost radiation therapy Standard | Boost radiation therapy Hypofractionation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2919491
UMLS CUI [1,2]
C1442989
UMLS CUI [2,1]
C2919491
UMLS CUI [2,2]
C1831786
adjuvant hormonal therapy will be allowed prior to, during, and/or after radiotherapy (rt) at the discretion of a medical oncologist
Beskrivning

Adjuvant Hormone Therapy

Datatyp

boolean

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

Targeted Therapy | Herceptin

Datatyp

boolean

Alias
UMLS CUI [1]
C2985566
UMLS CUI [2]
C0338204
no prior radiation to the involved breast or chest wall
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C1314939
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0205076
UMLS CUI [3,3]
C1314939
no concurrent chemotherapy
Beskrivning

Exclusion Criteria | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0392920
no patients who underwent breast reconstruction following mastectomy
Beskrivning

Exclusion Criteria | Mammaplasty Following Mastectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0085076
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0024881
placement of tissue expanders and implants are not allowed
Beskrivning

Exclusion Criteria | Insertion of tissue expander in breast | Breast implants

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0177682
UMLS CUI [3]
C0179412
no patients who have undergone mammosite® or any other form of brachytherapy as well as those who will be treated with skin-sparing imrt
Beskrivning

Exclusion Criteria | Balloon brachytherapy | Brachytherapy Any | Intensity-Modulated Radiotherapy Except Skin

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1832047
UMLS CUI [3,1]
C0006098
UMLS CUI [3,2]
C1552551
UMLS CUI [4,1]
C1512814
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C1123023
patients may not be concurrently enrolled in a protocol that involves treatment of the skin, i.e., applying lotions/moisturizers
Beskrivning

Exclusion Criteria | Study Subject Participation Status | Involvement with Treatment Skin | Application Lotion | Application of moisturizer to skin

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C2348568
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1123023
UMLS CUI [4,1]
C0185125
UMLS CUI [4,2]
C0544341
UMLS CUI [5]
C0455079
protocols that do not involve treatment of the skin are allowed
Beskrivning

Treatment Skin Uninvolved | Study Protocol allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1123023
UMLS CUI [1,3]
C0205429
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0683607
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Similar models

Eligibility Breast Cancer NCT01407770

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Gender | Breast Carcinoma | DCIS
Item
female patients newly diagnosed with breast carcinoma including ductal carcinoma in situ (dcis)
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
Disease TNM Breast tumor staging
Item
stage 0-iiia disease
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
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 Adjuvant Planned
Item
plan to receive adjuvant radiation to the whole breast or chest wall and/or 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])
C1522673 (UMLS CUI [3,3])
C1301732 (UMLS CUI [3,4])
Exclusion Criteria | Blood specimen Unavailable | Urine specimen Unavailable
Item
no sites that cannot send blood/urine specimens to wake forest by overnight (next day) express shipping
boolean
C0680251 (UMLS CUI [1])
C0178913 (UMLS CUI [2,1])
C0686905 (UMLS CUI [2,2])
C1610733 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ID.7
Item
*this stratum is closed as of april 25, 2012.
boolean
Exclusion Criteria | Comprehension English Language Unable | Consent Form Completion Assisted Unable
Item
no patients who do not understand english and are unable to complete form with assistance
boolean
C0680251 (UMLS CUI [1])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0009797 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C1269765 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Therapeutic radiology procedure Cumulative Dose | Therapeutic radiology procedure Dose Fractionated | Therapeutic radiology procedure 2-Dimensional | Radiotherapy, Conformal | Radiotherapy, Intensity-Modulated | Hypofractionated radiation therapy Whole breast
Item
total dose > 40 gy, dose per fraction > 1.8 - 2.0 gy, use of 2d, 3d-conformal, or intensity-modulated radiation therapy (imrt) treatment techniques allowed; a daily fraction of 2.7 gy to the whole breast is suggested for hypofractionated regimens
boolean
C1522449 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1979893 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C1705052 (UMLS CUI [3,2])
C0600521 (UMLS CUI [4])
C1512814 (UMLS CUI [5])
C1831786 (UMLS CUI [6,1])
C0457102 (UMLS CUI [6,2])
Boost radiation therapy Standard | Boost radiation therapy Hypofractionation
Item
concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
boolean
C2919491 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C2919491 (UMLS CUI [2,1])
C1831786 (UMLS CUI [2,2])
Adjuvant Hormone Therapy
Item
adjuvant hormonal therapy will be allowed prior to, during, and/or after radiotherapy (rt) at the discretion of a medical oncologist
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
Targeted Therapy | Herceptin
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])
Exclusion Criteria | Prior radiation therapy Breast Involved | Prior radiation therapy Chest wall Involved
Item
no prior radiation to the involved breast or chest wall
boolean
C0680251 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0205076 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
Exclusion Criteria | Chemotherapy
Item
no concurrent chemotherapy
boolean
C0680251 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Exclusion Criteria | Mammaplasty Following Mastectomy
Item
no patients who underwent breast reconstruction following mastectomy
boolean
C0680251 (UMLS CUI [1])
C0085076 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0024881 (UMLS CUI [2,3])
Exclusion Criteria | Insertion of tissue expander in breast | Breast implants
Item
placement of tissue expanders and implants are not allowed
boolean
C0680251 (UMLS CUI [1])
C0177682 (UMLS CUI [2])
C0179412 (UMLS CUI [3])
Exclusion Criteria | Balloon brachytherapy | Brachytherapy Any | Intensity-Modulated Radiotherapy Except Skin
Item
no patients who have undergone mammosite® or any other form of brachytherapy as well as those who will be treated with skin-sparing imrt
boolean
C0680251 (UMLS CUI [1])
C1832047 (UMLS CUI [2])
C0006098 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
C1512814 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C1123023 (UMLS CUI [4,3])
Exclusion Criteria | Study Subject Participation Status | Involvement with Treatment Skin | Application Lotion | Application of moisturizer to skin
Item
patients may not be concurrently enrolled in a protocol that involves treatment of the skin, i.e., applying lotions/moisturizers
boolean
C0680251 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C1314939 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1123023 (UMLS CUI [3,3])
C0185125 (UMLS CUI [4,1])
C0544341 (UMLS CUI [4,2])
C0455079 (UMLS CUI [5])
Treatment Skin Uninvolved | Study Protocol allowed
Item
protocols that do not involve treatment of the skin are allowed
boolean
C0087111 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C0205429 (UMLS CUI [1,3])
C2348563 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
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