Eligibility Breast Cancer NCT00816985

1 moduli

StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT00816985

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Item

patient selection involves identifying women who have undergone breast cancer surgery in the past and who demonstrate lymphedema (stage 2 or 3) based on arm measurement at a minimum of 4 different points along the affected arm. those women with mild to severe lymphedema with no signs of active infection are candidates for the procedure. history of previous non-surgical treatment for lymphedema will not preclude entry into this trial. all patients must be free of active disease recurrence at study entry. if the lymphedema is of recent onset, then the womans medical oncologist or primary care physician must rule out an underlying cancer recurrence or blood clot.

boolean

C0079399 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0024236 (UMLS CUI [3,1])
C1306673 (UMLS CUI [3,2])
C1140618 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C1140618 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C3714763 (UMLS CUI [5,3])
C1705242 (UMLS CUI [5,4])
C1265611 (UMLS CUI [5,5])
C0024236 (UMLS CUI [6,1])
C2945599 (UMLS CUI [6,2])
C0024236 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0009450 (UMLS CUI [8,1])
C0311392 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
C0087111 (UMLS CUI [9,1])
C0024236 (UMLS CUI [9,2])
C0277556 (UMLS CUI [10,1])
C0332296 (UMLS CUI [10,2])
C0302148 (UMLS CUI [11,1])
C0332197 (UMLS CUI [11,2])

Manual lymphatic drainage | Compression sleeves | Operative Surgical Procedures Lymphedema Ineligible

Item

prior therapy including manuel lymph drainage (mld) or similar massage method, use of compression sleeves, and pneumatic pumps is allowable and may be on-going at study entry. prior surgical procedures to treat lymphedema such a joining the lymph channels to the blood vessels at any prior time are not eligible for this study.

boolean

C0556834 (UMLS CUI [1])
C0183617 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0024236 (UMLS CUI [3,2])
C1512714 (UMLS CUI [3,3])

ECOG performance status | Karnofsky Performance Status

Item

eastern cooperative oncology group (ecog) performance status ≤2 (karnofsky ≥60%.

boolean

C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])

Life Expectancy

Item

life expectancy of greater than one year

boolean

C0023671 (UMLS CUI [1])

Organ function | Bone Marrow function

Item

patients must have normal organ and marrow function as defined below:

boolean

C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])

White Blood Cell Count procedure

Item

1. leukocytes ≥3,000/microl

boolean

C0023508 (UMLS CUI [1])

Absolute neutrophil count

Item

2. absolute neutrophil count ≥1,500/microl

boolean

C0948762 (UMLS CUI [1])

Platelet Count measurement

Item

3. platelets ≥100,000/microl

boolean

C0032181 (UMLS CUI [1])

Serum total bilirubin measurement

Item

4. total bilirubin within normal institutional limits

boolean

C1278039 (UMLS CUI [1])

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Item

5. aspartic transaminase(ast)/alanine transaminase(alt) ≤2.5 x institutional upper limit of normal

boolean

C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])

Creatinine measurement, serum | Creatinine clearance measurement

Item

6. creatinine within normal institutional limits - or - creatinine clearance ≥60 ml/min/1.73 m² for patients with creatinine levels above institutional normal.

boolean

C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])

Item

able to tolerate general anesthesia and have no recent cardiac history such as myocardial infarction, congestive heart failure, atrial fibrillation, or angina

boolean

C0002915 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0004238 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0002962 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])

Informed Consent

Item

ability to understand and the willingness to sign a written informed consent document

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Item

patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

boolean

C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0877248 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C1115804 (UMLS CUI [6,1])
C0332268 (UMLS CUI [6,2])

Investigational New Drugs

Item

patients may not be receiving any other investigational agents.

boolean

C0013230 (UMLS CUI [1])

Neoplasm Metastasis

Item

patients with known metastases should be excluded from this clinical trial because of their poor prognosis.

boolean

C0027627 (UMLS CUI [1])

Allergic Reaction Compression sleeves | Allergic Reaction Lymphedema Bandage | Allergic Reaction General anesthetics | Allergic Reaction Antibiotics

Item

history of allergic reactions to compression sleeves, lymphedema bandages, general anesthetics, and all antibiotics

boolean

C1527304 (UMLS CUI [1,1])
C0183617 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0024236 (UMLS CUI [2,2])
C0004726 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0017302 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0003232 (UMLS CUI [4,2])

Item

uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

boolean

C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])

Pregnancy | General Anesthesia Risk Increased Miscarriage | Operative Surgical Procedures Risk Increased Miscarriage | Increased weight Causing Exacerbation Lymphedema | Interpretation Endpoints Difficult

Item

pregnant women are excluded from this study because: general anesthesia and/or invasive surgical procedures may increase the risk of miscarriage. secondly, increased weight during pregnancy may exacerbate lymphedema and thereby make interpretation of the study endpoints difficult.

boolean

C0032961 (UMLS CUI [1])
C0002915 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
C0000786 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0205217 (UMLS CUI [3,3])
C0000786 (UMLS CUI [3,4])
C0043094 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C4086268 (UMLS CUI [4,3])
C0024236 (UMLS CUI [4,4])
C0459471 (UMLS CUI [5,1])
C2349179 (UMLS CUI [5,2])
C0332218 (UMLS CUI [5,3])

Immunologic Deficiency Syndromes | Operative Surgical Procedures Risk Increased Communicable Disease Lethal | Surgical Team High risk Needlestick Injuries

Item

patients with immune deficiency are at increased risk of lethal infections when treated with invasive surgical procedures. secondly, since this is an elective procedure, the risk to the surgical team of a needle stick would be too high.

boolean

C0021051 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
C0009450 (UMLS CUI [2,4])
C3151529 (UMLS CUI [2,5])
C0520261 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C0085178 (UMLS CUI [3,3])

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Eligibility Breast Cancer NCT00816985