Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT01544335
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
* Participants must have undergone sentinel node mapping or axillary dissection
* Life expectancy of greater than 1 year.
* Willingness to comply with required follow up Perometer and BIS measurements and completion of LEFT-BC questionnaire
Exclusion Criteria:
* Patients who have known metastatic disease or other locally advanced disease in the thoracic or cervical regions
* Any patient who will not be returning routinely for follow-up at MGH or DFHCC
* Participants with 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
* History of primary lymphedema
* History of prior surgery or radiation to the head, neck, upper limb, or trunk
* Participants who have evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion
* Any patient who has bilateral lymph node mapping or dissection
* Any patient with a current case of cellulitis
* 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 cancers 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01544335
Study Brief:
Protocol Section:
NCT01544335