Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers

NCT02258035 | Active Not Recruiting

• 1 other identifier: s57027
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human volunteers and use these purified proteins to cross-validate existing or novel assays for this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc for different vitamin D metabolites.

Conditions

Vitamin D Deficiency

Keywords

vitamin D binding protein (DBP)

Outcome Measures

Primary Outcomes (1)

• Vitamin D binding protein binding characteristics (affinity constant)

  In vitro characterization

  single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer

Secondary Outcomes (1)

• Correlation coefficient (r) of different DBP assays

  single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer

Study Arms (3)

DBP/Gc1f-1f genotype

Human volunteers homozygous for the 1f-1f (fast) genotype of DBP.

Other: Blood draw

DBP/Gc1s-1s genotype

Human volunteers homozygous for the 1s-1s (slow) genotype of DBP.

Other: Blood draw

DBP/Gc 2-2 genotype

Human volunteers homozygous for the 2-2 genotype of DBP.

Other: Blood draw

Interventions

Blood draw OTHER

Sampling of 100-150 ml of blood

DBP/Gc 2-2 genotype; DBP/Gc1f-1f genotype; DBP/Gc1s-1s genotype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known genotype of DBP/Gc, as identified in the clinical database of the Multidisciplinary Breast Centre, University Hospitals Leuven, and free of breast cancer recurrence at the time of blood sampling.

You may qualify if:

• Generally healthy adults (≥ 18 years), non pregnant, with known DBP/Gc genotype

You may not qualify if:

• Inability to provide written informed consent
• No children or pregnant women
• Persons with known abnormal serum proteins

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Hatse S, Lambrechts D, Verstuyf A, Smeets A, Brouwers B, Vandorpe T, Brouckaert O, Peuteman G, Laenen A, Verlinden L, Kriebitzsch C, Dieudonne AS, Paridaens R, Neven P, Christiaens MR, Bouillon R, Wildiers H. Vitamin D status at breast cancer diagnosis: correlation with tumor characteristics, disease outcome, and genetic determinants of vitamin D insufficiency. Carcinogenesis. 2012 Jul;33(7):1319-26. doi: 10.1093/carcin/bgs187. Epub 2012 May 23.

  PMID: 22623648 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum will be derived from 100-150 ml of blood and used for protein purification

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dirk Vanderschueren, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Roger Bouillon, MD PhD

  UZ Leuven

  STUDY CHAIR

• Hans Wildiers, MD PhD

  UZ Leuven

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 7, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)