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Trial record 4 of 38 for:    Recruiting, Not yet recruiting, Available Studies | "Sweat"

A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor

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ClinicalTrials.gov Identifier: NCT03367494
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Vender, Milton S. Hershey Medical Center

Brief Summary:
Cystic Fibrosis (CF) is a hereditary multi-system disease affecting approximately 30,000n children and adults in the USA. The diagnosis of CF requires biochemical confirmation (either abnormal sweat chloride measurement and/or identification of two CF disease causing mutations) plus clinical symptomatology. Measurements of sweat chloride remain cumbersome and although most common methodology to confirm CF diagnosis with limitations especially in young children less than 6 months of age and in areas that lack ability for the complex testing. The study objectives of this current research proposal include: A) To expand upon previously obtained pilot study data "Evaluation of a fluorescent-based chloride sensor as an optical sweat test to diagnose cystic fibrosis" B) To add the exploratory measurement of sweat Bromide as a first in human assessment observation, C) To Evaluate the development of smartphone based point-of-care technology for chloride and bromide sensor measurements, D) To further expand the class of citrate-based sensors with improved fluorescence and sensing properties for the design of new fluorescence-based analytical and diagnostic solutions based on the automated multi-halide detection system, and E) To develop point-of-care systems that can successfully integrate into clinical settings to improve current practices and facilitate early detection of disease.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Subjects with Cystic Fibrosis
Diagnostic
Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide
Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors

Healthy Volunteers
Diagnostic
Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide
Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors




Primary Outcome Measures :
  1. Sweat chloride measurements in sweat samples via ion exchange chromatography [ Time Frame: anticipated 12 months ]
    Sweat specimen samples obtained via pilocarpine iontophoresis will be measured for sweat chloride. Measurements for chloride will be determined by ion exchange chromatography measured in millimolar (mM).

  2. Sweat chloride measurements in sweat samples via fluorescence quenching [ Time Frame: anticipated 12 months ]
    Sweat specimen samples obtained via pilocarpine iontophoresis will be measured for sweat chloride. Measurements for the chloride will be determined by fluorescence citrate-based sensors, measured in millimolar (mM).

  3. Sweat bromide measurements in sweat samples via fluorescence quenching [ Time Frame: anticipated 12 months ]
    Sweat specimen samples obtained via pilocarpine iontophoresis will be measured for sweat bromide. Measurements for bromide will be determined by fluorescence citrate-based sensors, measured in millimolar (mM).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 18 years of age or older capable of providing written informed consent AND
  • Patients with an established diagnosis of Cystic Fibrosis (CF) OR Healthy volunteers

Exclusion Criteria:

  • Participants under medications or with disorders known to cause a positive error in the sweat test will be excluded in the study. Common causes of positive error in sweat test are mineralocorticoid hormone therapy, adrenal insufficiency, glycogen storage diseases, hypothyroidism, hypoparathyroidism, nephrogenic diabetes insipidus, G6PD deficiency or ectodermal dysplasia OR
  • Any other skin or soft tissue disorders that could affect obtaining the necessary volumes of sweat.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367494


Contacts
Contact: Robert Vender, MD 717-531-7772 rvender@pennstatehealth.psu.edu

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Robert L Vender, MD    717-531-6525    rvender@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center

Publications:
Responsible Party: Robert Vender, Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03367494     History of Changes
Other Study ID Numbers: 00008612
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: No personally identifiable information will be communicated to investigators at PSU-University Park. Sweat samples will be identified solely by code which code will be linked to personally identifiable information known only to Dr. Vender and which code will be kept in a locked office at Hershey Medical Center (HMC) Biomedical Research Building C5860. This code will contain participant (both CF patients and healthy volunteers): name, HMC medical record #, age, gender, date of sample, date of birth and sweat chloride/bromide results. In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared. Personally identifiable health information access (such as diagnosis, name, HMC medical record#, age, gender, date of birth) is specifically for Cystic Fibrosis patients. Medical records and health information will NOT be accessed for healthy control volunteers, however name, age, gender, date of birth will be recorded.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bromides
Citric Acid
Anticonvulsants
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action