ID

37927

Description

A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01262716

Link

https://clinicaltrials.gov/show/NCT01262716

Keywords

Versions (1)
  1. 8/31/19 8/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01262716

English

Eligibility Breast Cancer NCT01262716

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients > 18 years of age, with primary or metastatic cutaneous tumors that may or may not have been previously irradiated.
Description

Age | Skin Neoplasms | Secondary malignant neoplasm of skin | Prior radiation therapy | Prior radiation therapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0037286
UMLS CUI [3]
C0153687
UMLS CUI [4]
C0279134
UMLS CUI [5,1]
C0279134
UMLS CUI [5,2]
C0332197
ecog performance status < 3.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
Description

Absence Cancer treatment Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0205373
patients must not have received radiation therapy to the target site within 60 days of enrolling on this study.
Description

Absence Therapeutic radiology procedure Target Site

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C2348654
skin of target site and control site must be grade 0 or 1 by common terminology
Description

Skin Target Site Grade | Skin Control Site Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C2348654
UMLS CUI [1,3]
C0441800
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C0243148
UMLS CUI [2,3]
C1515974
UMLS CUI [2,4]
C0441800
patients must have a target lesion and normal peri-umbilical skin that can be covered by the fiber-optic mesh used to deliver clipt (10 x 10 cm, or 3 x 3).
Description

Target Lesion Identification | Skin of periumbilical region Normal

Data type

boolean

Alias
UMLS CUI [1]
C2986546
UMLS CUI [2,1]
C0448830
UMLS CUI [2,2]
C0205307
if located on an extremity, the target lesion must not cover more than 50% of the diameter of the extremity at the level at which it is located.
Description

Target Lesion Location Extremity | Target Lesion Percentage Diameter Extremity

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0015385
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C1301886
UMLS CUI [2,4]
C0015385
absolute neutrophil count > 1000.
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
adequate coagulation status as indicated by platelet count > 50,000, pt and ptt < 1.5 time the upper limit of normal.
Description

Blood coagulation status | Platelet Count measurement | Prothrombin time assay | Activated Partial Thromboplastin Time measurement

Data type

boolean

Alias
UMLS CUI [1]
C1321069
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0033707
UMLS CUI [4]
C0030605
patients must sign informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
male patients not considered for this study.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
patients must have a target lesion in a location other than the hands, feet, genitals, or face. lesions in those locations will be excluded.
Description

Target Lesion Location Hands | Target Lesion Location Feet | Target Lesion Location Genitals | Target Lesion Location Face

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0018563
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0016504
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C1515974
UMLS CUI [3,3]
C0017420
UMLS CUI [4,1]
C2986546
UMLS CUI [4,2]
C1515974
UMLS CUI [4,3]
C0015450
patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded.
Description

Medical condition Associated with Photosensitivity | Porphyria variegata, cutaneous | Collagen-vascular disease | Hypersensitivity Porphyrins

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0349506
UMLS CUI [2]
C0543653
UMLS CUI [3]
C0262428
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0032712
pregnant and nursing patients will be excluded. women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment.
Description

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones, st. john's wort and amiodarone) will be excluded.
Description

Pharmaceutical Preparations Causing Photosensitivity | Tetracycline | Sulfonamides | phenothiazine | Sulfonylurea Compounds | Hypoglycemic Agents | Thiazide Diuretics | Griseofulvin | Fluoroquinolones | ST. JOHN'S WORT EXTRACT | Amiodarone

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0349506
UMLS CUI [2]
C0039644
UMLS CUI [3]
C0038760
UMLS CUI [4]
C0031434
UMLS CUI [5]
C0038766
UMLS CUI [6]
C0020616
UMLS CUI [7]
C0012802
UMLS CUI [8]
C0018242
UMLS CUI [9]
C0949665
UMLS CUI [10]
C0813171
UMLS CUI [11]
C0002598
patients with severe hepatic dysfunction (total bilirubin, ast, or alt > five times upper limit of normal) will be excluded.
Description

Liver Dysfunction Severe | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
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Similar models

Eligibility Breast Cancer NCT01262716

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Skin Neoplasms | Secondary malignant neoplasm of skin | Prior radiation therapy | Prior radiation therapy Absent
Item
patients > 18 years of age, with primary or metastatic cutaneous tumors that may or may not have been previously irradiated.
boolean
C0001779 (UMLS CUI [1])
C0037286 (UMLS CUI [2])
C0153687 (UMLS CUI [3])
C0279134 (UMLS CUI [4])
C0279134 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
ECOG performance status
Item
ecog performance status < 3.
boolean
C1520224 (UMLS CUI [1])
Absence Cancer treatment Systemic
Item
patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
boolean
C0332197 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
Absence Therapeutic radiology procedure Target Site
Item
patients must not have received radiation therapy to the target site within 60 days of enrolling on this study.
boolean
C0332197 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C2348654 (UMLS CUI [1,3])
Skin Target Site Grade | Skin Control Site Grade
Item
skin of target site and control site must be grade 0 or 1 by common terminology
boolean
C1123023 (UMLS CUI [1,1])
C2348654 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C1123023 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C0441800 (UMLS CUI [2,4])
Target Lesion Identification | Skin of periumbilical region Normal
Item
patients must have a target lesion and normal peri-umbilical skin that can be covered by the fiber-optic mesh used to deliver clipt (10 x 10 cm, or 3 x 3).
boolean
C2986546 (UMLS CUI [1])
C0448830 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Target Lesion Location Extremity | Target Lesion Percentage Diameter Extremity
Item
if located on an extremity, the target lesion must not cover more than 50% of the diameter of the extremity at the level at which it is located.
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0015385 (UMLS CUI [2,4])
Absolute neutrophil count
Item
absolute neutrophil count > 1000.
boolean
C0948762 (UMLS CUI [1])
Blood coagulation status | Platelet Count measurement | Prothrombin time assay | Activated Partial Thromboplastin Time measurement
Item
adequate coagulation status as indicated by platelet count > 50,000, pt and ptt < 1.5 time the upper limit of normal.
boolean
C1321069 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
C0030605 (UMLS CUI [4])
Informed Consent
Item
patients must sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender
Item
male patients not considered for this study.
boolean
C0079399 (UMLS CUI [1])
Target Lesion Location Hands | Target Lesion Location Feet | Target Lesion Location Genitals | Target Lesion Location Face
Item
patients must have a target lesion in a location other than the hands, feet, genitals, or face. lesions in those locations will be excluded.
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0018563 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0016504 (UMLS CUI [2,3])
C2986546 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C0017420 (UMLS CUI [3,3])
C2986546 (UMLS CUI [4,1])
C1515974 (UMLS CUI [4,2])
C0015450 (UMLS CUI [4,3])
Medical condition Associated with Photosensitivity | Porphyria variegata, cutaneous | Collagen-vascular disease | Hypersensitivity Porphyrins
Item
patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded.
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0349506 (UMLS CUI [1,3])
C0543653 (UMLS CUI [2])
C0262428 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0032712 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
pregnant and nursing patients will be excluded. women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
Pharmaceutical Preparations Causing Photosensitivity | Tetracycline | Sulfonamides | phenothiazine | Sulfonylurea Compounds | Hypoglycemic Agents | Thiazide Diuretics | Griseofulvin | Fluoroquinolones | ST. JOHN'S WORT EXTRACT | Amiodarone
Item
patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones, st. john's wort and amiodarone) will be excluded.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0349506 (UMLS CUI [1,3])
C0039644 (UMLS CUI [2])
C0038760 (UMLS CUI [3])
C0031434 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C0020616 (UMLS CUI [6])
C0012802 (UMLS CUI [7])
C0018242 (UMLS CUI [8])
C0949665 (UMLS CUI [9])
C0813171 (UMLS CUI [10])
C0002598 (UMLS CUI [11])
Liver Dysfunction Severe | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
patients with severe hepatic dysfunction (total bilirubin, ast, or alt > five times upper limit of normal) will be excluded.
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
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