ID

35074

Beskrivning

Monitoring Neoadjuvant Chemotherapy Response in Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging; ODM derived from: https://clinicaltrials.gov/show/NCT02510456

Länk

https://clinicaltrials.gov/show/NCT02510456

Nyckelord

Versioner (1)
  1. 2019-02-13 2019-02-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02510456

Engelsk

Eligibility Breast Cancer NCT02510456

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female;
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
2. diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy;
Beskrivning

Invasive carcinoma of breast Examination of breast | Invasive carcinoma of breast Diagnostic Imaging | Invasive carcinoma of breast Biopsy tissue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0199850
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0011923
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C3864006
3. planned for primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor following completion of neoadjuvant chemotherapy;
Beskrivning

Systemic Chemotherapy Primary Neoadjuvant Planned | Excision Primary tumor Residual | Status post Chemotherapy Neoadjuvant Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1298676
UMLS CUI [1,4]
C1301732
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C0677930
UMLS CUI [2,3]
C1609982
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C1298676
UMLS CUI [3,4]
C0205197
4. tumor size ≥ 2cm, measured on imaging or estimated by physical exam;
Beskrivning

Tumor size Imaging | Tumor size Physical Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C0031809
5. planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;
Beskrivning

Operation on breast Planned | Mastectomy | Segmental Mastectomy | Breast-Conserving Surgery | Status post Neoadjuvant Therapy Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0024881
UMLS CUI [3]
C0024885
UMLS CUI [4]
C0917927
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0600558
UMLS CUI [5,3]
C0205197
6. age 18 years or older;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
7. eastern cooperative oncology group (ecog) performance status ≤ 2 (karnofsky performance status ≥ 60%;
Beskrivning

ECOG performance status | Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
8. adequate organ and marrow function, as defined at boston medical center;
Beskrivning

Organ function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
9. postmenopausal for a minimum of one year, or surgically sterile, or not pregnant, confirmed by a pregnancy test as per institutional standard of care, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;
Beskrivning

Postmenopausal state | Female Sterilization | Pregnancy Absent | Pregnancy test negative | Contraceptive methods Willing | Hormonal contraception | Contraception, Barrier

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0427780
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C0600109
UMLS CUI [6]
C2985296
UMLS CUI [7]
C0004764
10. able to understand and willing to sign a written informed consent document and a health insurance portability and accountability act (hipaa) authorization in accordance with institutional guidelines.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous treatment (chemotherapy, radiation, or surgery) to involved breast;
Beskrivning

Prior Therapy Breast Involved | Chemotherapy Breast Involved | Therapeutic radiology procedure Breast Involved | Operative Surgical Procedures Breast Involved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C1314939
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C1314939
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0006141
UMLS CUI [3,3]
C1314939
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0006141
UMLS CUI [4,3]
C1314939
2. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
Beskrivning

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
3. medically unstable;
Beskrivning

Unstable status Medical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0205476
4. under age 18;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. pregnant or nursing;
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years;
Beskrivning

Malignant Neoplasms Previous | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
7. no contraindications for primary chemotherapy.
Beskrivning

Medical contraindication Chemotherapy Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205225
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Similar models

Eligibility Breast Cancer NCT02510456

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
1. female;
boolean
C0079399 (UMLS CUI [1])
Invasive carcinoma of breast Examination of breast | Invasive carcinoma of breast Diagnostic Imaging | Invasive carcinoma of breast Biopsy tissue
Item
2. diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy;
boolean
C0853879 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C0853879 (UMLS CUI [3,1])
C3864006 (UMLS CUI [3,2])
Systemic Chemotherapy Primary Neoadjuvant Planned | Excision Primary tumor Residual | Status post Chemotherapy Neoadjuvant Completion
Item
3. planned for primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor following completion of neoadjuvant chemotherapy;
boolean
C1883256 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1298676 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0728940 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C1609982 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1298676 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
Tumor size Imaging | Tumor size Physical Examination
Item
4. tumor size ≥ 2cm, measured on imaging or estimated by physical exam;
boolean
C0475440 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Operation on breast Planned | Mastectomy | Segmental Mastectomy | Breast-Conserving Surgery | Status post Neoadjuvant Therapy Completion
Item
5. planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;
boolean
C3714726 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2])
C0024885 (UMLS CUI [3])
C0917927 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C0600558 (UMLS CUI [5,2])
C0205197 (UMLS CUI [5,3])
Age
Item
6. age 18 years or older;
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
7. eastern cooperative oncology group (ecog) performance status ≤ 2 (karnofsky performance status ≥ 60%;
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Organ function | Bone Marrow function
Item
8. adequate organ and marrow function, as defined at boston medical center;
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Pregnancy Absent | Pregnancy test negative | Contraceptive methods Willing | Hormonal contraception | Contraception, Barrier
Item
9. postmenopausal for a minimum of one year, or surgically sterile, or not pregnant, confirmed by a pregnancy test as per institutional standard of care, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0427780 (UMLS CUI [4])
C0700589 (UMLS CUI [5,1])
C0600109 (UMLS CUI [5,2])
C2985296 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
Informed Consent
Item
10. able to understand and willing to sign a written informed consent document and a health insurance portability and accountability act (hipaa) authorization in accordance with institutional guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Breast Involved | Chemotherapy Breast Involved | Therapeutic radiology procedure Breast Involved | Operative Surgical Procedures Breast Involved
Item
1. previous treatment (chemotherapy, radiation, or surgery) to involved breast;
boolean
C1514463 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0006141 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C0006141 (UMLS CUI [4,2])
C1314939 (UMLS CUI [4,3])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
2. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Unstable status Medical
Item
3. medically unstable;
boolean
C0443343 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
Age
Item
4. under age 18;
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
5. pregnant or nursing;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms Previous | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration
Item
6. previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years;
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Medical contraindication Chemotherapy Primary
Item
7. no contraindications for primary chemotherapy.
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
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