Trial Radar IA | ||
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Lo studio clinico NCT06305884 per Neoplasia del sistema ematopoietico e linfoide, Linfedema, Neoplasia Solida Maligna è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study
I. Describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes participants with lymphedema in comparison to participants without lymphedema at rest.
SECONDARY OBJECTIVES:
I. In participants with lymphedema, describe a unique signature using a combination of photoplethysmography and bioimpedance that distinguishes the affected arm in comparison to the unaffected arm.
II. Tolerability of the transcutaneous sensors during the participant data collection session.
III. Use a combination of photoplethysmography and bioimpedance to identify likely cut points for lymphedema in participants with lymphedema.
OUTLINE:
Participants undergo BI and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
Project Limb Rescue: A Pilot Study Evaluating the Feasibility of Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleDiagnostic (BI, PPG) Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study. | Analisi dell'impedenza bioelettrica Undergo BI Esercizio Pedal an exercise bike Fotopletismografia Undergo PPG Somministrazione del questionario Ancillary studies |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Unique signature describing photoplethysmography and bioimpedance at rest and during activity | Will assess in the following groups: (1) Healthy dominant arm, (2) healthy recessive arm, (3) lymphedema normal arm and (4) lymphedema affected arm. A single continuous value will be developed from the amplitude over time for each participant, both at rest and during activity. These measurements will be summarized using descriptive statistics (means, standard deviations or medians and interquartile ranges). | Up to 2 hours |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Patient reported outcomes | Assess by the Lymph-Q questionnaire. Will be summarized by cohort and compared between cohorts using the methods outlined above for continuous variables and either a Chi-square test or Fisher's Exact test for categorical variables. | Up to 2 hours |
Tolerability of sensors | Assess by the Tolerability questionnaire. Will be summarized by cohort and compared between cohorts using the methods outlined above for continuous variables and either a Chi-square test or Fisher's Exact test for categorical variables. | Up to 2 hours |
Likely classification for lymphedema | Will examine receiver operator characteristics using data from groups 3 and 4. Sensitivity, specificity, and area under that curve will be calculated, however these will be considered preliminary. | Up to 2 hours |
- COHORT A: Healthy participants
- COHORT B: Participants with pre-existing lymphedema
- COHORT B: A history of cancer therapy with surgery or radiation involving the axillary basin
- COHORT B: Unilateral upper extremity swelling that requires compression or pneumatic therapy or a >= 2-centimeter difference in contralateral arm circumference
- Patients with active malignancy or ongoing cancer therapy will be excluded, though breast cancer patients currently on endocrine monotherapy will be included
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