ID

35003

Description

VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02294565

Lien

https://clinicaltrials.gov/show/NCT02294565

Mots-clés

Versions (1)
  1. 07/02/2019 07/02/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 février 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02294565

Anglais

Eligibility Breast Cancer NCT02294565

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of primary breast cancer.
Description

Breast Carcinoma Primary

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
diagnosed with invasive adenocarcinoma, or dcis for which a slnb is the recommended standard of care, or breast cancer with all of the following conditions met:
Description

Adenocarcinoma Invasive | DCIS | Sentinel Lymph Node Biopsy Standard of Care

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C0007124
UMLS CUI [3,1]
C0796693
UMLS CUI [3,2]
C2936643
fna results positive for cancer cells
Description

Fine needle aspiration Positive Cancer cells

Type de données

boolean

Alias
UMLS CUI [1,1]
C1510483
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0334227
positive clinical breast examination
Description

Examination of breast Positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0199850
UMLS CUI [1,2]
C1514241
mammography and/or us and/or mri abnormality(ies) consistent with malignancy.
Description

Mammography Abnormality Consistent with Malignant Neoplasms | Ultrasonography Abnormality Consistent with Malignant Neoplasms | MRI Abnormality Consistent with Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024671
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C0006826
UMLS CUI [2,1]
C0041618
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0332290
UMLS CUI [2,4]
C0006826
UMLS CUI [3,1]
C0024485
UMLS CUI [3,2]
C1704258
UMLS CUI [3,3]
C0332290
UMLS CUI [3,4]
C0006826
n0 and m0 at the time of study entry.
Description

TNM Breast tumor staging

Type de données

boolean

Alias
UMLS CUI [1]
C0474926
ecog 0, 1, or 2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a tumor with direct extension to the chest wall and/or to the skin.
Description

Malignant Neoplasm Direct Extension Chest wall | Malignant Neoplasm Direct Extension Skin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3899369
UMLS CUI [1,3]
C0205076
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C3899369
UMLS CUI [2,3]
C1123023
diffuse tumors or multiple malignant tumors in the breast.
Description

Diffuse tumor configuration Breast | Multiple tumors Breast

Type de données

boolean

Alias
UMLS CUI [1,1]
C1276429
UMLS CUI [1,2]
C0006141
UMLS CUI [2,1]
C0260037
UMLS CUI [2,2]
C0006141
prior breast malignancy of the ipsilateral breast.
Description

Breast Carcinoma Previous Breast Ipsilateral

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0441989
patient currently receiving or had prior treatment for the currently diagnosed breast cancer.
Description

Therapeutic procedure Breast Carcinoma Current

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C4540931
medical conditions and/or prior surgical procedures that have the potential to substantially alter the lymphatic drainage pattern from the primary tumor to the lymph node basin.
Description

Medical condition Changing Drainage of lymphatics | Operative Surgical Procedures Changing Drainage of lymphatics

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0398480
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0398480
inability to localize 1 or 2 lymph node drainage basin(s) via lymphatic mapping.
Description

Localization Lymphatic Basin Quantity Unable | Localization via Lymphatic mapping

Type de données

boolean

Alias
UMLS CUI [1,1]
C0475264
UMLS CUI [1,2]
C2986565
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0475264
UMLS CUI [2,2]
C1550513
UMLS CUI [2,3]
C1518048
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Similar models

Eligibility Breast Cancer NCT02294565

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Primary
Item
diagnosis of primary breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Adenocarcinoma Invasive | DCIS | Sentinel Lymph Node Biopsy Standard of Care
Item
diagnosed with invasive adenocarcinoma, or dcis for which a slnb is the recommended standard of care, or breast cancer with all of the following conditions met:
boolean
C0001418 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
C0796693 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
Fine needle aspiration Positive Cancer cells
Item
fna results positive for cancer cells
boolean
C1510483 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0334227 (UMLS CUI [1,3])
Examination of breast Positive
Item
positive clinical breast examination
boolean
C0199850 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Mammography Abnormality Consistent with Malignant Neoplasms | Ultrasonography Abnormality Consistent with Malignant Neoplasms | MRI Abnormality Consistent with Malignant Neoplasms
Item
mammography and/or us and/or mri abnormality(ies) consistent with malignancy.
boolean
C0024671 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0041618 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
C0024485 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0332290 (UMLS CUI [3,3])
C0006826 (UMLS CUI [3,4])
TNM Breast tumor staging
Item
n0 and m0 at the time of study entry.
boolean
C0474926 (UMLS CUI [1])
ECOG performance status
Item
ecog 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm Direct Extension Chest wall | Malignant Neoplasm Direct Extension Skin
Item
a tumor with direct extension to the chest wall and/or to the skin.
boolean
C0006826 (UMLS CUI [1,1])
C3899369 (UMLS CUI [1,2])
C0205076 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C3899369 (UMLS CUI [2,2])
C1123023 (UMLS CUI [2,3])
Diffuse tumor configuration Breast | Multiple tumors Breast
Item
diffuse tumors or multiple malignant tumors in the breast.
boolean
C1276429 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0260037 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
Breast Carcinoma Previous Breast Ipsilateral
Item
prior breast malignancy of the ipsilateral breast.
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0441989 (UMLS CUI [1,4])
Therapeutic procedure Breast Carcinoma Current
Item
patient currently receiving or had prior treatment for the currently diagnosed breast cancer.
boolean
C0087111 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C4540931 (UMLS CUI [1,3])
Medical condition Changing Drainage of lymphatics | Operative Surgical Procedures Changing Drainage of lymphatics
Item
medical conditions and/or prior surgical procedures that have the potential to substantially alter the lymphatic drainage pattern from the primary tumor to the lymph node basin.
boolean
C3843040 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0398480 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0398480 (UMLS CUI [2,3])
Localization Lymphatic Basin Quantity Unable | Localization via Lymphatic mapping
Item
inability to localize 1 or 2 lymph node drainage basin(s) via lymphatic mapping.
boolean
C0475264 (UMLS CUI [1,1])
C2986565 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0475264 (UMLS CUI [2,1])
C1550513 (UMLS CUI [2,2])
C1518048 (UMLS CUI [2,3])
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