ID

26018

Description

A Pilot Study To Evaluate the Effectiveness of Pulsed Time-Domain Optical Spectroscopy for Monitoring the Responses in Neoadjuvant Treatments of Locally-Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00438074

Link

https://clinicaltrials.gov/show/NCT00438074

Keywords

Versions (2)
  1. 10/2/17 10/2/17 -
  2. 10/4/17 10/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00438074

English

Eligibility Breast Cancer NCT00438074

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advance breast cancer
Description

Locally advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C3495949
subjects must give appropriate written informed consent prior to participation in the study;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects must be able and willing to comply with the safety procedures during the scanning period;
Description

Compliance behavior Safety procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1269689
subjects must be women of between 20 and 80 years of age, inclusive, on the day the informed consent form is signed;
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
subjects must be women who will be receiving neoadjuvant radiation therapy and/or chemotherapy for locally-advanced breast cancer.
Description

Gender | Therapeutic radiology procedure Neoadjuvant Locally advanced breast cancer | Chemotherapy Neoadjuvant Locally advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C3495949
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C3495949
subjects of childbearing potential must be using an acceptable method of birth control. subjects not of childbearing potential are defined as either surgically sterile or post-menopausal. post-menopausal women are defined as those women with a documented menstruation cessation for 12 consecutive months prior to signing the informed consent form
Description

Childbearing Potential Contraceptive methods | Female Sterilization | Postmenopausal state | Amenorrhea Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0002453
UMLS CUI [4,2]
C0449238
undefined item
Description

undefined item

Data type

text

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g.,silicone/saline implants) involving either breast, exclusive of the lesion at issue;
Description

Abnormality Involvement with Breast | Traumatic injury Involvement with Breast | Medical procedure Involvement with Breast | Operation on breast | Silicone implant | Saline breast implant | Lesion Involved Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0006141
UMLS CUI [2,1]
C3263723
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0006141
UMLS CUI [3,1]
C0199171
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0006141
UMLS CUI [4]
C3714726
UMLS CUI [5]
C1289793
UMLS CUI [6]
C0741712
UMLS CUI [7,1]
C0221198
UMLS CUI [7,2]
C1314939
UMLS CUI [7,3]
C2828389
subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast;
Description

Skin Abnormalities Involvement with Breast | Tattoo | Sore Open | Skin lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0037268
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0006141
UMLS CUI [2]
C1366940
UMLS CUI [3,1]
C1442877
UMLS CUI [3,2]
C0175566
UMLS CUI [4]
C0037284
subjects with a current or past medical history of connective tissue disease;
Description

Connective Tissue Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009782
subjects who are pregnant or lactating;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator;
Description

Implanted Medical Device Electronic | Artificial cardiac pacemaker | Defibrillators | Stimulators, Neurological

Data type

boolean

Alias
UMLS CUI [1,1]
C2828363
UMLS CUI [1,2]
C0013850
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0180307
UMLS CUI [4]
C0183597
subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations;
Description

Anxiety Associated with Evaluation Diagnostic

Data type

boolean

Alias
UMLS CUI [1,1]
C0003467
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0348026
subjects with a history of musculoskeletal disease which may predispose them to discomfort during the scanning period;
Description

Musculoskeletal Disease

Data type

boolean

Alias
UMLS CUI [1]
C0026857
subjects with a known sensitivity to purified water, soybean oil, sucrose, polysorbate 80, oleic acid, edta, benzalkonium chloride, fd&c caramel color, butylated hydroxyanisole, and/or sodium hydroxide;
Description

Hypersensitivity Purified water | Hypersensitivity Soybean Oil | Hypersensitivity Sucrose | Hypersensitivity Polysorbate 80 | Hypersensitivity Oleic Acid | Hypersensitivity EDTA | Hypersensitivity Benzalkonium Chloride | Hypersensitivity Caramel Color | Hypersensitivity Butylated Hydroxyanisole | Hypersensitivity Sodium Hydroxide

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0991883
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0037732
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0038636
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0032601
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0028928
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0013618
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0005026
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0108509
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0006506
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0037517
subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and
Description

Hypersensitivity Infrared Radiation Level low

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021431
UMLS CUI [1,3]
C0441889
UMLS CUI [1,4]
C0205251
subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study.
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Breast Cancer NCT00438074

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer
Item
locally advance breast cancer
boolean
C3495949 (UMLS CUI [1])
Informed Consent
Item
subjects must give appropriate written informed consent prior to participation in the study;
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Safety procedure
Item
subjects must be able and willing to comply with the safety procedures during the scanning period;
boolean
C1321605 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Gender | Age
Item
subjects must be women of between 20 and 80 years of age, inclusive, on the day the informed consent form is signed;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Therapeutic radiology procedure Neoadjuvant Locally advanced breast cancer | Chemotherapy Neoadjuvant Locally advanced breast cancer
Item
subjects must be women who will be receiving neoadjuvant radiation therapy and/or chemotherapy for locally-advanced breast cancer.
boolean
C0079399 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C3495949 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C3495949 (UMLS CUI [3,3])
Childbearing Potential Contraceptive methods | Female Sterilization | Postmenopausal state | Amenorrhea Duration
Item
subjects of childbearing potential must be using an acceptable method of birth control. subjects not of childbearing potential are defined as either surgically sterile or post-menopausal. post-menopausal women are defined as those women with a documented menstruation cessation for 12 consecutive months prior to signing the informed consent form
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0002453 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
undefined item
Item
text
Item Group
C0680251 (UMLS CUI)
Abnormality Involvement with Breast | Traumatic injury Involvement with Breast | Medical procedure Involvement with Breast | Operation on breast | Silicone implant | Saline breast implant | Lesion Involved Excluded
Item
subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g.,silicone/saline implants) involving either breast, exclusive of the lesion at issue;
boolean
C1704258 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C3263723 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0006141 (UMLS CUI [2,3])
C0199171 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0006141 (UMLS CUI [3,3])
C3714726 (UMLS CUI [4])
C1289793 (UMLS CUI [5])
C0741712 (UMLS CUI [6])
C0221198 (UMLS CUI [7,1])
C1314939 (UMLS CUI [7,2])
C2828389 (UMLS CUI [7,3])
Skin Abnormalities Involvement with Breast | Tattoo | Sore Open | Skin lesion
Item
subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast;
boolean
C0037268 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C1366940 (UMLS CUI [2])
C1442877 (UMLS CUI [3,1])
C0175566 (UMLS CUI [3,2])
C0037284 (UMLS CUI [4])
Connective Tissue Diseases
Item
subjects with a current or past medical history of connective tissue disease;
boolean
C0009782 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
subjects who are pregnant or lactating;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Implanted Medical Device Electronic | Artificial cardiac pacemaker | Defibrillators | Stimulators, Neurological
Item
subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator;
boolean
C2828363 (UMLS CUI [1,1])
C0013850 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0180307 (UMLS CUI [3])
C0183597 (UMLS CUI [4])
Anxiety Associated with Evaluation Diagnostic
Item
subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations;
boolean
C0003467 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0348026 (UMLS CUI [1,4])
Musculoskeletal Disease
Item
subjects with a history of musculoskeletal disease which may predispose them to discomfort during the scanning period;
boolean
C0026857 (UMLS CUI [1])
Hypersensitivity Purified water | Hypersensitivity Soybean Oil | Hypersensitivity Sucrose | Hypersensitivity Polysorbate 80 | Hypersensitivity Oleic Acid | Hypersensitivity EDTA | Hypersensitivity Benzalkonium Chloride | Hypersensitivity Caramel Color | Hypersensitivity Butylated Hydroxyanisole | Hypersensitivity Sodium Hydroxide
Item
subjects with a known sensitivity to purified water, soybean oil, sucrose, polysorbate 80, oleic acid, edta, benzalkonium chloride, fd&c caramel color, butylated hydroxyanisole, and/or sodium hydroxide;
boolean
C0020517 (UMLS CUI [1,1])
C0991883 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0037732 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0038636 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0032601 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0028928 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0013618 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0005026 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0108509 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0006506 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0037517 (UMLS CUI [10,2])
Hypersensitivity Infrared Radiation Level low
Item
subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and
boolean
C0020517 (UMLS CUI [1,1])
C0021431 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
Study Subject Participation Status Inappropriate
Item
subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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