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Trial Radar IA
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.
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Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06305884 è uno studio interventistico per Neoplasia del sistema ematopoietico e linfoide, Linfedema, Neoplasia Solida Maligna, attualmente in arruolamento. Avviato il 22 aprile 2024, prevede di arruolare 77 partecipanti. Sotto la guida di l'Università statale dell'Ohio, dovrebbe concludersi entro il 20 dicembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 29 giugno 2025.
Sommario breve
This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home.
Descrizione dettagliata
PRIMARY OBJECTIVE:

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.

Titolo ufficiale

Project Limb Rescue: A Pilot Study Evaluating the Feasibility of Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema

Condizioni
Neoplasia del sistema ematopoietico e linfoideLinfedemaNeoplasia Solida Maligna
Altri ID dello studio
Numero NCT
Data di inizio (effettiva)
2024-04-22
Ultimo aggiornamento pubblicato
2025-06-29
Data di completamento (stimata)
2025-12-20
Arruolamento (previsto)
77
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Diagnostico
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/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
Esito primario
Misure di esitoDescrizione della misuraArco 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
Esito secondario
Misure di esitoDescrizione della misuraArco 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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
  • 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 State University Comprehensive Cancer Center logoUniversità statale dell'Ohio455 studi clinici attivi da esplorare
Parte responsabile dello studio
Carlo Contreras, Investigatore principale, Principal Investigator, Ohio State University Comprehensive Cancer Center
Contatti principali dello studio
Contatto: The Ohio State Comprehensive Cancer Center, 800-293-5066, [email protected]
Contatto: Shannon Hainline, [email protected]
1 Centri dello studio in 1 paesi

Ohio

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Carlo M. Contreras, MD, Contatto, 614-293-3465, [email protected]
Carlo M. Contreras, MD, Investigatore principale
In arruolamento