LymphSEARCH screening - Risk of lymphoedema after breast cancer treatment

LymphSEARCH screening study - Incidence and prognostic factors for secondary lymphoedema in breast cancer patients

Registry ID
ISRCTN14341053
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Uppsala University Hospital
Enrollment
350
Start date
2025-05-16
Completion date
2030-12-31
Last update
2026-08-17

Conditions

Summary

Lymphoedema in breast cancer patients

Detailed description

Observational: Patients are included after breast cancer diagnosis but before start of treatment. A baseline visit is performed with assessment of arm volume, bioimpedance, biomarkers, genetics, patient-reported outcome measures and mapping of lymphatic vessel anatomy in addition to clinical background data. Observation period is 2 years with subsequent visits for repeated measures at 3, 6, 12, 24, 36 months which is also end of follow-up.

Interventions

Inclusion criteria

1. Females age 18 years or older 2. Diagnosis of invasive breast cancer 3. Planned breast cancer treatment at Uppsala University Hospital 4. Informed written consent to participate in the study

Exclusion criteria

1. Guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 2. Previous diagnosis of lymphoedema in the upper extremity 3. Previous bilateral radiotherapy treatment for diagnosis other than breast cancer (ipsilateral radiotherapy is not an exclusion criterion, i.e. same side as current breast cancer diagnosis) 4. Previous chemotherapy for a malignant diagnosis other than breast cancer within 12 months prior to breast cancer diagnosis 5. Previous axillary surgery for diagnosis other than breast cancer

Locations

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