ID

30305

Description

Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00959985

Lien

https://clinicaltrials.gov/show/NCT00959985

Mots-clés

Versions (1)
  1. 28/05/2018 28/05/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

28 mai 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Lymphedema NCT00959985

Anglais

Eligibility Lymphedema NCT00959985

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphedema NCT00959985
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
Description

Invasive carcinoma of breast | Breast Carcinoma In situ

Type de données

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0444498
participants must have undergone sentinel lymph node mapping or axillary dissection
Description

Sentinel lymph node mapping | Excision of axillary lymph nodes

Type de données

boolean

Alias
UMLS CUI [1]
C1519247
UMLS CUI [2]
C0193867
participants must have had a pre-operative perometer measurement, and consecutive measurement at 4-6 month intervals prior to the onset of low volume edema (>5% from baseline)
Description

Other Coding Measurement Preoperative | Status pre- Edema Volume low

Type de données

boolean

Alias
UMLS CUI [1,1]
C3846158
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C0445204
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0013604
UMLS CUI [2,3]
C0449468
UMLS CUI [2,4]
C0205251
age > 18 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of greater than 1 year
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
participants must have a perometer measurement of 5% or greater volume difference (rvc) to qualify for randomization
Description

Other Coding Measurement | Relative Volume Change Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C3846158
UMLS CUI [1,2]
C0242485
UMLS CUI [2,1]
C1442097
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0439165
ability to understand and willingness to sign a written informed consent document
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
willingness to comply with required follow up perometer measurements and clinical visits
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known metastatic disease or other locally advanced disease in the thoracic or cervical regions
Description

Neoplasm Metastasis Thoracic region | Neoplasm Metastasis Cervical region | Advanced disease Locally Thoracic region | Advanced disease Locally Cervical region

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0817096
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0556956
UMLS CUI [3,1]
C0679246
UMLS CUI [3,2]
C1517927
UMLS CUI [3,3]
C0817096
UMLS CUI [4,1]
C0679246
UMLS CUI [4,2]
C1517927
UMLS CUI [4,3]
C0556956
any patient who will not be returning routinely for follow-up
Description

Patient Unavailable Follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0686905
UMLS CUI [1,3]
C3274571
known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Description

Metastatic malignant neoplasm to brain | Prognosis bad | Progressive neurologic dysfunction Interferes with Evaluation Neurological event | Progressive neurologic dysfunction Interferes with Evaluation Adverse event

Type de données

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0278252
UMLS CUI [3,1]
C4013375
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C1320718
UMLS CUI [4,1]
C4013375
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C0877248
history of primary lymphedema
Description

Lymphedema praecox

Type de données

boolean

Alias
UMLS CUI [1]
C0238261
history of prior surgery or radiation to the head, neck, upper limb, or trunk
Description

Operative procedure on head | Radiotherapy to head | Operation on neck | Radiotherapy to neck | Operative procedure on upper extremity | UPPER EXTREMITY RADIATION | Operation on trunk | Therapeutic radiology procedure Trunk

Type de données

boolean

Alias
UMLS CUI [1]
C0195772
UMLS CUI [2]
C1997353
UMLS CUI [3]
C0185773
UMLS CUI [4]
C1997944
UMLS CUI [5]
C0186318
UMLS CUI [6]
C0749835
UMLS CUI [7]
C0185774
UMLS CUI [8,1]
C1522449
UMLS CUI [8,2]
C0460005
evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion
Description

Axillary lymph node Malignant Neoplasm Causing Lymphedema | Etiology Recurrent disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0024236
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0277556
any patient who has bilateral lymph node mapping or dissection
Description

Lymphatic mapping Bilateral | Lymph node excision Bilateral

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518048
UMLS CUI [1,2]
C0238767
UMLS CUI [2,1]
C0024203
UMLS CUI [2,2]
C0238767
any patient with a current case of cellulitis
Description

Cellulitis

Type de données

boolean

Alias
UMLS CUI [1]
C0007642
patients with a history of a different malignancy are ineligible except for the following circumstances. individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. individuals with the following cancer are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
Description

Cancer Other | Exception Disease Free of | Exception Low Risk Recurrent Malignant Neoplasm | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3538919
UMLS CUI [3,3]
C1458156
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0553723
UMLS CUI [6,3]
C1522326
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Similar models

Eligibility Lymphedema NCT00959985

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Lymphedema NCT00959985
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Breast Carcinoma In situ
Item
participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
boolean
C0853879 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0444498 (UMLS CUI [2,2])
Sentinel lymph node mapping | Excision of axillary lymph nodes
Item
participants must have undergone sentinel lymph node mapping or axillary dissection
boolean
C1519247 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
Other Coding Measurement Preoperative | Status pre- Edema Volume low
Item
participants must have had a pre-operative perometer measurement, and consecutive measurement at 4-6 month intervals prior to the onset of low volume edema (>5% from baseline)
boolean
C3846158 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C0332152 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
C0449468 (UMLS CUI [2,3])
C0205251 (UMLS CUI [2,4])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 1 year
boolean
C0023671 (UMLS CUI [1])
Other Coding Measurement | Relative Volume Change Percentage
Item
participants must have a perometer measurement of 5% or greater volume difference (rvc) to qualify for randomization
boolean
C3846158 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1442097 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Informed Consent
Item
ability to understand and willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willingness to comply with required follow up perometer measurements and clinical visits
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Thoracic region | Neoplasm Metastasis Cervical region | Advanced disease Locally Thoracic region | Advanced disease Locally Cervical region
Item
known metastatic disease or other locally advanced disease in the thoracic or cervical regions
boolean
C0027627 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0556956 (UMLS CUI [2,2])
C0679246 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C0817096 (UMLS CUI [3,3])
C0679246 (UMLS CUI [4,1])
C1517927 (UMLS CUI [4,2])
C0556956 (UMLS CUI [4,3])
Patient Unavailable Follow-up
Item
any patient who will not be returning routinely for follow-up
boolean
C0030705 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain | Prognosis bad | Progressive neurologic dysfunction Interferes with Evaluation Neurological event | Progressive neurologic dysfunction Interferes with Evaluation Adverse event
Item
known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
boolean
C0220650 (UMLS CUI [1])
C0278252 (UMLS CUI [2])
C4013375 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C1320718 (UMLS CUI [3,4])
C4013375 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0877248 (UMLS CUI [4,4])
Lymphedema praecox
Item
history of primary lymphedema
boolean
C0238261 (UMLS CUI [1])
Operative procedure on head | Radiotherapy to head | Operation on neck | Radiotherapy to neck | Operative procedure on upper extremity | UPPER EXTREMITY RADIATION | Operation on trunk | Therapeutic radiology procedure Trunk
Item
history of prior surgery or radiation to the head, neck, upper limb, or trunk
boolean
C0195772 (UMLS CUI [1])
C1997353 (UMLS CUI [2])
C0185773 (UMLS CUI [3])
C1997944 (UMLS CUI [4])
C0186318 (UMLS CUI [5])
C0749835 (UMLS CUI [6])
C0185774 (UMLS CUI [7])
C1522449 (UMLS CUI [8,1])
C0460005 (UMLS CUI [8,2])
Axillary lymph node Malignant Neoplasm Causing Lymphedema | Etiology Recurrent disease
Item
evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion
boolean
C0729594 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0024236 (UMLS CUI [1,4])
C0015127 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
Lymphatic mapping Bilateral | Lymph node excision Bilateral
Item
any patient who has bilateral lymph node mapping or dissection
boolean
C1518048 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0024203 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
Cellulitis
Item
any patient with a current case of cellulitis
boolean
C0007642 (UMLS CUI [1])
Cancer Other | Exception Disease Free of | Exception Low Risk Recurrent Malignant Neoplasm | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
patients with a history of a different malignancy are ineligible except for the following circumstances. individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. individuals with the following cancer are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C1458156 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0553723 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
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