ID

26613

Description

Safety Study Using Photodynamic Therapy Light Therapy for Patients With Chest Wall Progression of Breast Cancer and Satellite Metastases of Melanoma; ODM derived from: https://clinicaltrials.gov/show/NCT00862901

Link

https://clinicaltrials.gov/show/NCT00862901

Keywords

Versions (1)
  1. 10/22/17 10/22/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00862901

English

Eligibility Breast Cancer NCT00862901

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients > 18 years of age, with primary or metastatic cutaneous tumors that have been previously irradiated.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0037286
UMLS CUI [2,2]
C0205225
UMLS CUI [3]
C0153687
UMLS CUI [4]
C0279134
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 for target lesion, and 1 x 1 cm for control site).
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
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 Identification | Location of lesion Hand Excluded | Location of lesion Foot Excluded | Location of lesion Genitalia Excluded | Location of lesion Face Excluded

Data type

boolean

Alias
UMLS CUI [1]
C2986546
UMLS CUI [2,1]
C2184261
UMLS CUI [2,2]
C0018563
UMLS CUI [2,3]
C2828389
UMLS CUI [3,1]
C2184261
UMLS CUI [3,2]
C0016504
UMLS CUI [3,3]
C2828389
UMLS CUI [4,1]
C2184261
UMLS CUI [4,2]
C0017420
UMLS CUI [4,3]
C2828389
UMLS CUI [5,1]
C2184261
UMLS CUI [5,2]
C0015450
UMLS CUI [5,3]
C2828389
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
patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
Description

Cancer treatment Systemic

Data type

boolean

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

Therapeutic radiology procedure Target Site

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C2348654
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 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 [2,1]
C0032708
UMLS CUI [2,2]
C0221912
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) will be excluded.
Description

Pharmaceutical Preparations Causing Photosensitivity | Tetracyclines | Sulfonamides | Phenothiazines | Sulfonylurea | Hypoglycemic Agents | Thiazide Diuretics | Griseofulvin | Fluoroquinolones

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0349506
UMLS CUI [2]
C0039651
UMLS CUI [3]
C0038760
UMLS CUI [4]
C0031436
UMLS CUI [5]
C0038766
UMLS CUI [6]
C0020616
UMLS CUI [7]
C0012802
UMLS CUI [8]
C0018242
UMLS CUI [9]
C0949665
laboratory values (note: these are provided by the potential patient):
Description

Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C1254595
absolute neutrophil count > 1000.
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
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
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
negative urine or serum pregnancy test
Description

Urine pregnancy test negative | Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0430057
UMLS CUI [2]
C0430061
note: no cost to patient, and no compensation provided.
Description

Cost Patient Absent | Compensation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0010186
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0220808
UMLS CUI [2,2]
C0332197
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Similar models

Eligibility Breast Cancer NCT00862901

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Skin Neoplasms Primary | Secondary malignant neoplasm of skin | Prior radiation therapy
Item
patients > 18 years of age, with primary or metastatic cutaneous tumors that have been previously irradiated.
boolean
C0001779 (UMLS CUI [1])
C0037286 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0153687 (UMLS CUI [3])
C0279134 (UMLS CUI [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 for target lesion, and 1 x 1 cm for control site).
boolean
C2986546 (UMLS CUI [1])
C0448830 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Target Lesion Identification | Location of lesion Hand Excluded | Location of lesion Foot Excluded | Location of lesion Genitalia Excluded | Location of lesion Face Excluded
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])
C2184261 (UMLS CUI [2,1])
C0018563 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C2184261 (UMLS CUI [3,1])
C0016504 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
C2184261 (UMLS CUI [4,1])
C0017420 (UMLS CUI [4,2])
C2828389 (UMLS CUI [4,3])
C2184261 (UMLS CUI [5,1])
C0015450 (UMLS CUI [5,2])
C2828389 (UMLS CUI [5,3])
Informed Consent
Item
patients must sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Systemic
Item
patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
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
C1522449 (UMLS CUI [1,1])
C2348654 (UMLS CUI [1,2])
Medical condition Associated with Photosensitivity | Porphyria 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])
C0032708 (UMLS CUI [2,1])
C0221912 (UMLS CUI [2,2])
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 | Tetracyclines | Sulfonamides | Phenothiazines | Sulfonylurea | Hypoglycemic Agents | Thiazide Diuretics | Griseofulvin | Fluoroquinolones
Item
patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones) will be excluded.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0349506 (UMLS CUI [1,3])
C0039651 (UMLS CUI [2])
C0038760 (UMLS CUI [3])
C0031436 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C0020616 (UMLS CUI [6])
C0012802 (UMLS CUI [7])
C0018242 (UMLS CUI [8])
C0949665 (UMLS CUI [9])
Laboratory Results
Item
laboratory values (note: these are provided by the potential patient):
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count > 1000.
boolean
C0948762 (UMLS CUI [1])
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])
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])
Urine pregnancy test negative | Serum pregnancy test negative
Item
negative urine or serum pregnancy test
boolean
C0430057 (UMLS CUI [1])
C0430061 (UMLS CUI [2])
Cost Patient Absent | Compensation Absent
Item
note: no cost to patient, and no compensation provided.
boolean
C0010186 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0220808 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
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