ID

44220

Description

Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02482376

Link

https://clinicaltrials.gov/show/NCT02482376

Keywords

Versions (3)
  1. 2/12/19 2/12/19 -
  2. 2/12/19 2/12/19 -
  3. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02482376

English

Eligibility Breast Cancer NCT02482376

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
Description

Ductal carcinoma in situ | Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2]
C0853879
a. biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.
Description

Biopsy tissue Slide | Biopsy tissue Block | Diagnosis Confirmation

Data type

boolean

Alias
UMLS CUI [1,1]
C0521093
UMLS CUI [1,2]
C3864006
UMLS CUI [1,3]
C1705201
UMLS CUI [2,1]
C3864006
UMLS CUI [2,2]
C1533157
UMLS CUI [3,1]
C0011900
UMLS CUI [3,2]
C0750484
2. breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
Description

Patients Appropriate Breast Preservation | Radiotherapy to breast Absent | Radiotherapy to lymph nodes Absent | Absence Disease Multicentric Imaging | Absence Disease Multifocal Imaging | Pregnancy Absent | Absence Comorbidity Preventing Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C1514402
UMLS CUI [2,1]
C0948310
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1504399
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0439743
UMLS CUI [4,4]
C0011923
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0205292
UMLS CUI [5,4]
C0011923
UMLS CUI [6,1]
C0032961
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0332197
UMLS CUI [7,2]
C0009488
UMLS CUI [7,3]
C1292733
UMLS CUI [7,4]
C0543467
3. clinical t1n0m0 invasive carcinoma or ductal carcinoma in situ (dcis) < or equal to 2cm
Description

Invasive carcinoma of breast TNM Breast tumor staging | DCIS Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0007124
UMLS CUI [2,2]
C0456389
4. 60 years of age or older or 50-59 with a low oncotype score (0-17)
Description

Age | Oncotype test Score low

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C4523849
UMLS CUI [2,2]
C0449820
UMLS CUI [2,3]
C0205251
5. estrogen receptor positive (er+), human epidermal growth factor 2 negative (her2-)
Description

Estrogen receptor positive | HER2 Negative

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C2348908
6. women of child-bearing potential must consent to use adequate contraception during the course of the study. female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (iud). contraceptive measures such as plan b (tm), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
Description

Childbearing Potential Contraceptive methods | Female Sterilization | Tubal Ligation | Hysterectomy | Contraceptives, Oral, Hormonal | Contraceptives, Oral | Contraceptive patch | Contraceptive implant | Contraceptive injection | Contraception, Barrier | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | Plan B Unacceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0520483
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0009907
UMLS CUI [6]
C0009905
UMLS CUI [7]
C2985284
UMLS CUI [8]
C1657106
UMLS CUI [9]
C1656586
UMLS CUI [10]
C0004764
UMLS CUI [11]
C0221829
UMLS CUI [12]
C0042241
UMLS CUI [13]
C0087145
UMLS CUI [14]
C0021900
UMLS CUI [15,1]
C0876128
UMLS CUI [15,2]
C1883420
7. white blood cells (wbc) > 3000, hemoglobin ( hgb) > 9, platelets >100000 within 30 days of consent
Description

White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
8. eligible for contrasted magnetic resonance imaging (mri) on initial evaluation with glomerular filtration rate (gfr) ≥ 60 ml/min. a diagnostic mri ordered within one month will be considered an acceptable alternative and will not be repeated.
Description

Eligibility MRI with contrast | Glomerular Filtration Rate | MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0202671
UMLS CUI [2]
C0017654
UMLS CUI [3]
C0024485
9. outside breast imaging will be reviewed at duke to confirm findings are consistent with trial eligibility.
Description

Breast Imaging Consistent with Clinical Trial Eligibility Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C1516637
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. neoadjuvant chemotherapy
Description

Chemotherapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1298676
2. breast implant in the breast to be treated with sbrt
Description

Breast implant | Breast Planned Stereotactic Body Radiation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0179412
UMLS CUI [2,1]
C0006141
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C3896609
3. medical conditions that may increase risk for poor cosmetic outcome (i.e. lupus, rheumatoid arthritis, scleroderma)
Description

Medical condition At risk Unsatisfactory outcome of cosmetic surgery | Lupus Erythematosus | Rheumatoid Arthritis | Scleroderma

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C4546170
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0011644
4. subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
Description

Investigational Therapy Receive Unable | Lacking Able to lie down Prone Position

Data type

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0560841
UMLS CUI [2,3]
C0033422
5. her2 positive
Description

HER2 Positive

Data type

boolean

Alias
UMLS CUI [1]
C2348909
6. positive serum pregnancy test
Description

Serum pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0430063
7. insufficient breast imaging to judge clinical stage
Description

Breast Imaging Insufficient | TNM Breast tumor staging Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C0231180
UMLS CUI [2,1]
C0474926
UMLS CUI [2,2]
C1272705
8. subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
Description

Biopsy Clip placement Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C4489472
UMLS CUI [1,3]
C0558080
9. subjects in whom treatment planning constraints cannot be met
Description

Treatment Constraints Fulfill Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0443288
UMLS CUI [1,3]
C1550543
UMLS CUI [1,4]
C1272705
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Similar models

Eligibility Breast Cancer NCT02482376

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Ductal carcinoma in situ | Invasive carcinoma of breast
Item
1. women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
boolean
C0007124 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
Biopsy tissue Slide | Biopsy tissue Block | Diagnosis Confirmation
Item
a. biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.
boolean
C0521093 (UMLS CUI [1,1])
C3864006 (UMLS CUI [1,2])
C1705201 (UMLS CUI [1,3])
C3864006 (UMLS CUI [2,1])
C1533157 (UMLS CUI [2,2])
C0011900 (UMLS CUI [3,1])
C0750484 (UMLS CUI [3,2])
Patients Appropriate Breast Preservation | Radiotherapy to breast Absent | Radiotherapy to lymph nodes Absent | Absence Disease Multicentric Imaging | Absence Disease Multifocal Imaging | Pregnancy Absent | Absence Comorbidity Preventing Operative Surgical Procedures
Item
2. breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C1514402 (UMLS CUI [1,4])
C0948310 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1504399 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0439743 (UMLS CUI [4,3])
C0011923 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0205292 (UMLS CUI [5,3])
C0011923 (UMLS CUI [5,4])
C0032961 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0332197 (UMLS CUI [7,1])
C0009488 (UMLS CUI [7,2])
C1292733 (UMLS CUI [7,3])
C0543467 (UMLS CUI [7,4])
Invasive carcinoma of breast TNM Breast tumor staging | DCIS Size
Item
3. clinical t1n0m0 invasive carcinoma or ductal carcinoma in situ (dcis) < or equal to 2cm
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Age | Oncotype test Score low
Item
4. 60 years of age or older or 50-59 with a low oncotype score (0-17)
boolean
C0001779 (UMLS CUI [1])
C4523849 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
Estrogen receptor positive | HER2 Negative
Item
5. estrogen receptor positive (er+), human epidermal growth factor 2 negative (her2-)
boolean
C0279754 (UMLS CUI [1])
C2348908 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Female Sterilization | Tubal Ligation | Hysterectomy | Contraceptives, Oral, Hormonal | Contraceptives, Oral | Contraceptive patch | Contraceptive implant | Contraceptive injection | Contraception, Barrier | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | Plan B Unacceptable
Item
6. women of child-bearing potential must consent to use adequate contraception during the course of the study. female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (iud). contraceptive measures such as plan b (tm), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0520483 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0009907 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C2985284 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C1656586 (UMLS CUI [9])
C0004764 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
C0042241 (UMLS CUI [12])
C0087145 (UMLS CUI [13])
C0021900 (UMLS CUI [14])
C0876128 (UMLS CUI [15,1])
C1883420 (UMLS CUI [15,2])
White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement
Item
7. white blood cells (wbc) > 3000, hemoglobin ( hgb) > 9, platelets >100000 within 30 days of consent
boolean
C0023508 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Eligibility MRI with contrast | Glomerular Filtration Rate | MRI
Item
8. eligible for contrasted magnetic resonance imaging (mri) on initial evaluation with glomerular filtration rate (gfr) ≥ 60 ml/min. a diagnostic mri ordered within one month will be considered an acceptable alternative and will not be repeated.
boolean
C1548635 (UMLS CUI [1,1])
C0202671 (UMLS CUI [1,2])
C0017654 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
Breast Imaging Consistent with Clinical Trial Eligibility Criteria
Item
9. outside breast imaging will be reviewed at duke to confirm findings are consistent with trial eligibility.
boolean
C0006141 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C1516637 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Neoadjuvant
Item
1. neoadjuvant chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1298676 (UMLS CUI [1,2])
Breast implant | Breast Planned Stereotactic Body Radiation Therapy
Item
2. breast implant in the breast to be treated with sbrt
boolean
C0179412 (UMLS CUI [1])
C0006141 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C3896609 (UMLS CUI [2,3])
Medical condition At risk Unsatisfactory outcome of cosmetic surgery | Lupus Erythematosus | Rheumatoid Arthritis | Scleroderma
Item
3. medical conditions that may increase risk for poor cosmetic outcome (i.e. lupus, rheumatoid arthritis, scleroderma)
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C4546170 (UMLS CUI [1,3])
C0409974 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0011644 (UMLS CUI [4])
Investigational Therapy Receive Unable | Lacking Able to lie down Prone Position
Item
4. subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
boolean
C0949266 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0560841 (UMLS CUI [2,2])
C0033422 (UMLS CUI [2,3])
HER2 Positive
Item
5. her2 positive
boolean
C2348909 (UMLS CUI [1])
Serum pregnancy test positive
Item
6. positive serum pregnancy test
boolean
C0430063 (UMLS CUI [1])
Breast Imaging Insufficient | TNM Breast tumor staging Unsuccessful
Item
7. insufficient breast imaging to judge clinical stage
boolean
C0006141 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0474926 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Biopsy Clip placement Unwilling
Item
8. subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
boolean
C0005558 (UMLS CUI [1,1])
C4489472 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Treatment Constraints Fulfill Unsuccessful
Item
9. subjects in whom treatment planning constraints cannot be met
boolean
C0087111 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
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