RECRUITING

Parkinson's Disease Biomarkers in Nerve Cells in the Gut

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

Parkinson's disease affects all the nerve cells in the body, including the ones in the gut. The gut contains its own nervous system, the enteric nervous system, and can be thought of as a "second brain". This second brain can reflect what is going on in the actual brain. This study is being done to look for biomarkers, or early indicators of developing Parkinson's disease, in the microbiome and in the gut tissue taken during routine screening colonoscopy. People aged 45 and over who are due for their routine screening colonoscopy are eligible to participate.

Official Title

Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain

Quick Facts

Study Start:2020-12-30
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05347407

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:45 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 45-75 years old
  2. * Parkinson's Disease defined by the modified UK Parkinson's Disease Society Brain Bank criteria, at risk for the development of Parkinson's disease including REM sleep behavior disorder and/or at least one first degree relative with PD or related disorder, and diseases related to Parkinson's disease including the synucleinopathies Lewy Body Dementia and Multiple System Atrophy.
  3. * Baseline Hoehn \& Yahr score 1-4
  4. * No contraindications to undergoing screening colonoscopy
  5. * Able to give informed consent for study participation
  1. * Clinical features suggestive of a neurodegenerative diagnosis other than synucleinopathy.
  2. * Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease, Progressive Supranuclear Palsy (PSP), and Corticobasal syndrome.
  3. * Significant concomitant medical disease limiting life expectancy to less than 24 months from study inclusion, or significant and serious concomitant medical disease that is poorly controlled
  4. * Signs of active malignant disease or other clinically relevant abnormality on chest x-ray
  5. * Active or untreated gastrointestinal disease
  6. * Inability to temporarily stop anti-platelet agents or other anti-coagulants without significant risk
  7. * Known substance abuse (recent history of abuse of alcohol or other drugs such as barbiturates, cannabinoids and amphetamines) within last 5 years
  8. * Contraindication to colonoscopy or associated anesthesia
  9. * Pregnancy
  10. * In the opinion of the investigator, any other condition regarded as making subject unsuitable for the study

Contacts and Locations

Study Contact

Virginia Gao, MD PhD
CONTACT
3476103475
vig9070@med.cornell.edu
Jacqueline Burre, PhD
CONTACT
6469626155
jab2058@med.cornell.edu

Principal Investigator

Jacqueline Burre, PhD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Virginia M Gao, MD PhD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Jacqueline Burre, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University
  • Virginia M Gao, MD PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

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 Date2020-12-30
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2020-12-30
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • microbiome
  • Parkinson's
  • RBD
  • Alpha Synuclein
  • enteric nervous system

Additional Relevant MeSH Terms

  • Parkinson Disease