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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.
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Kaartweergave

Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study

Recruterend
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De klinische studie NCT06305884 is een interventioneel studie bij Neoplasma van het hematopoëtische en lymfoïde systeem, Lymfoedeem, Kwaadaardige Solide Neoplasma met de status recruterend. Het doel is om 77 deelnemers te includeren vanaf 22 april 2024. De studie wordt geleid door Ohio State University en de voltooiing is gepland op 20 december 2025. Laatste update op ClinicalTrials.gov: 29 juni 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.

Officiële titel

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

Aandoeningen
Neoplasma van het hematopoëtische en lymfoïde systeemLymfoedeemKwaadaardige Solide Neoplasma
Andere studie-ID's
NCT-ID
Startdatum (Werkelijk)
2024-04-22
Laatste update geplaatst
2025-06-29
Verwachte einddatum
2025-12-20
Inschrijving (Geschat)
77
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Primaire doel
Diagnostisch
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/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
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
  • 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
Verantwoordelijke instantie
Carlo Contreras, Hoofdonderzoeker, Principal Investigator, Ohio State University Comprehensive Cancer Center
Centraal Contactpersoon
Contact: The Ohio State Comprehensive Cancer Center, 800-293-5066, [email protected]
Contact: Shannon Hainline, [email protected]
1 Studielocaties in 1 landen

Ohio

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Carlo M. Contreras, MD, Contact, 614-293-3465, [email protected]
Carlo M. Contreras, MD, Hoofdonderzoeker
Recruterend