Trial Radar AI | ||
|---|---|---|
De klinische studie NCT06305884 voor Neoplasma van het hematopoëtische en lymfoïde systeem, Lymfoedeem, Kwaadaardige Solide Neoplasma is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelDiagnostic (BI, PPG) Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study. | Bio-elektrische impedantie analyse Undergo BI Oefening Pedal an exercise bike Fotoplethysmografie Undergo PPG Vragenlijstadministratie Ancillary studies |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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
Ohio