Biomarker for Cystic Fibrosis

NCT02710383 | Terminated DMC

• 1 other identifier: BCF 06-2018
• Study Type: observational
• Target: 54
• Locations: 5 countries
• Sites: 5

Brief Summary

International, multicenter, observational, longitudinal study to identify biomarker/s for Cystic fibrosis and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s

Conditions

Chronic Nasal Congestion; Lung Infection; Breathlessness; Clubbing Toes; Meconium Ileus; Failure to Thrive; Pancreatitis

Keywords

Cystic Fibrosis; Biomarker

Outcome Measures

Primary Outcomes (1)

• Identification of Cystic fibrosis biomarker/s

  All samples will be analyzed for the identification of biomarker/s via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS) and compared to merged control, in order to establish the disease-specific biomarker/s. The LC/MRM-MS is performed on an ABSciex 6500 triple quadrupole mass spectrometer, coupled with a Waters Acquity UPLC

  36 months

Secondary Outcomes (1)

• Exploring the clinical robustness, specificity, and long-term variability of Cystic fibrosis biomarker/s

  36 months

Study Arms (1)

Participants genetically diagnosed with Cystic fibrosis

Participants diagnosed with Cystic fibrosis aged between 2 months and 50 years

Eligibility Criteria

• Age: 2 Months - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants genetically diagnosed with Cystic fibrosis

You may qualify if:

• Informed consent is obtained from the participant or the parent/ legal guardian
• The participant is aged between 2 months and 50 years
• The diagnosis of Cystic fibrosis is genetically confirmed by CENTOGENE

You may not qualify if:

• Informed consent is not obtained from the participant or from the parent/ legal guardian
• The participant is younger than 2 months or older than 50 years
• The diagnosis of Cystic fibrosis is not genetically confirmed by CENTOGENE

Sponsors & Collaborators

• CENTOGENE GmbH Rostock: lead

Study Sites (5)

University Hospital Center Mother Teresa

Tirana, 10001, Albania

Location

Department of Molecular and Medical Genetics, Tbilisi State Medical University

Tbilisi, 0177, Georgia

Location

Amrita Institute of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

Location

Department of Pediatric Gastroenterology and Hepatology, The Children's Hospital and Institute of Child Health

Lahore, 54600, Pakistan

Location

Lady Ridgeway Hospital for Children

Colombo, 00800c, Sri Lanka

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)

MeSH Terms

Conditions

Dyspnea; Meconium Ileus; Failure to Thrive; Pancreatitis; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pancreatic Diseases; Lung Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Peter Bauer, Prof. Dr.

  Centogene GmbH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 16, 2016
• Study Start: August 20, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

PA (1); IN (1); SR (1); AL (1); GE (1)