ID

38249

Description

Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01394315

Link

https://clinicaltrials.gov/show/NCT01394315

Keywords

  1. 10/2/19 10/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 2, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT01394315

Eligibility Breast Neoplasms NCT01394315

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients receiving neoadjuvant chemotherapy for breast cancer.
Description

Neoadjuvant Chemotherapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0678222
patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging.
Description

Locally advanced breast cancer | Large tumor Operable | Neoadjuvant Therapy Required

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2,1]
C0475278
UMLS CUI [2,2]
C0205188
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C1514873
histological confirmation of invasive breast carcinoma.
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned.
Description

Neoplasm Metastasis | Neoplasm Metastasis minor | Operation on breast Planned | Status post Neoadjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0205165
UMLS CUI [3,1]
C3714726
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0600558
UMLS CUI [4,3]
C3665472
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age equal to or more than 21 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy greater than 12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
fungating or ulcerated tumours
Description

Fungating tumor | Ulcerated tumor

Data type

boolean

Alias
UMLS CUI [1]
C1446352
UMLS CUI [2]
C1276438
inability to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
anticipated inability to follow-up patient for response to chemotherapy
Description

Follow-up Unable Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C3840775
any contraindication to undergoing ultrasound, mri, mmg or dot
Description

Medical contraindication Ultrasonography | Medical contraindication MRI | Medical contraindication Mammography | Medical contraindication Diffuse Optical Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0041618
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0024671
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C1328868

Similar models

Eligibility Breast Neoplasms NCT01394315

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Neoadjuvant Chemotherapy Breast Carcinoma
Item
patients receiving neoadjuvant chemotherapy for breast cancer.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Locally advanced breast cancer | Large tumor Operable | Neoadjuvant Therapy Required
Item
patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging.
boolean
C3495949 (UMLS CUI [1])
C0475278 (UMLS CUI [2,1])
C0205188 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Invasive carcinoma of breast
Item
histological confirmation of invasive breast carcinoma.
boolean
C0853879 (UMLS CUI [1])
Neoplasm Metastasis | Neoplasm Metastasis minor | Operation on breast Planned | Status post Neoadjuvant Chemotherapy
Item
patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned.
boolean
C0027627 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0205165 (UMLS CUI [2,2])
C3714726 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C3665472 (UMLS CUI [4,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age equal to or more than 21 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than 12 weeks.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Fungating tumor | Ulcerated tumor
Item
fungating or ulcerated tumours
boolean
C1446352 (UMLS CUI [1])
C1276438 (UMLS CUI [2])
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Follow-up Unable Anticipated
Item
anticipated inability to follow-up patient for response to chemotherapy
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
Medical contraindication Ultrasonography | Medical contraindication MRI | Medical contraindication Mammography | Medical contraindication Diffuse Optical Tomography
Item
any contraindication to undergoing ultrasound, mri, mmg or dot
boolean
C1301624 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0024671 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C1328868 (UMLS CUI [4,2])

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