RECRUITING

Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.

Official Title

Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At - Home Measures

Quick Facts

Study Start:2021-06-01
Study Completion:2031-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05137665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Laura Dugom, MPH
CONTACT
919-440-2073
laura.dugom@targetals.org
Robert Bowser, PhD
CONTACT
602-406-8989
robert.bowser@dignityhealth.org

Principal Investigator

Laura Dugom, MPH
STUDY_DIRECTOR
Target ALS Foundation, Inc.
Amy Easton, PhD
STUDY_DIRECTOR
Target ALS Foundation, Inc.

Study Locations (Sites)

Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
University of California San Diego
San Diego, California, 92121
United States
Georgetown University
Georgetown, District of Columbia, 20007
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Northwestern University
Chicago, Illinois, 60611
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Washington University
Saint Louis, Missouri, 63110
United States
Columbia University
New York, New York, 10032
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Target ALS Foundation, Inc.

  • Laura Dugom, MPH, STUDY_DIRECTOR, Target ALS Foundation, Inc.
  • Amy Easton, PhD, STUDY_DIRECTOR, Target ALS Foundation, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01
Study Completion Date2031-12-31

Study Record Updates

Study Start Date2021-06-01
Study Completion Date2031-12-31

Terms related to this study

Keywords Provided by Researchers

  • Amyotrophic Lateral Sclerosis
  • ALS Amyotrophic Lateral Sclerosis
  • Target ALS
  • Longitudinal Biofluids
  • Barrow Neurological Institute
  • New York Genome Center
  • Biofluids Biorepository
  • Genomic-wide association studies
  • observational study
  • Biofluid Samples

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis
  • Movement Disorders
  • Degenerative Disorder
  • Motor Neuron Disease