NCT02989792

Brief Summary

Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling for genotyping purposes. In addition they will compete the personality questionnaires they had completed in the former trial.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2017

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

8 months

First QC Date

December 5, 2016

Last Update Submit

May 6, 2019

Conditions

Peripheral NeuropathyOsteoarthritis

Keywords

pain

Outcome Measures

Primary Outcomes (5)

  • Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase

    SNPs will be analyzed with Sanger based genotyping or equivalent method

    Time zero equals baseline

  • Number of participants with SNPs variation of monoamine oxidase

    SNPs will be analyzed with Sanger based genotyping or equivalent method

    Time zero equals baseline

  • Number of participants with SNPs variation of dopamine B hydroxylase

    SNPs will be analyzed with Sanger based genotyping or equivalent method

    Time zero equals baseline

  • Number of participants with SNPs variation of dopamine receptor 3

    SNPs will be analyzed with Sanger based genotyping or equivalent method

    Time zero equals baseline

  • Number of participants with SNPs variation of brain-derived neurotropic factor genes

    SNPs will be analyzed with Sanger based genotyping or equivalent method

    Time zero equals baseline

Secondary Outcomes (7)

  • Number of participants with SNPs variation of tryptophan hydroxylase-2

    Time zero equals baseline

  • Number of participants with SNPs variation of 5-hydroxytryptamine transporter

    Time zero equals baseline

  • Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A

    Time zero equals baseline

  • Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes

    Time zero equals baseline

  • Number of participants with SNPs variation of opioid receptor gene

    Time zero equals baseline

  • +2 more secondary outcomes

Study Arms (1)

Unique study arm

OTHER
Genetic: Blood sampling for genotypingOther: Personality Questionnaires completion

Interventions

Blood sampling for genotypingGENETIC

Venous punction of maximum 10 millilitres

Unique study arm
Personality Questionnaires completionOTHER

Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires

Unique study arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have completed T1001-01 or T1001-02 study (Visit 5 completed)
  • are men or women of at least 18 years of age
  • have given written informed consent approved by the relevant Ethics Committee governing the study sites

You may not qualify if:

  • have any close relationship with the Investigators or the Sponsor
  • are under legal protection, according to the national law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ATC SA

Liège, 4000, Belgium

Location

CIC Clermont-Ferrand CHU G. Montpied

Clermont-Ferrand, 63003, France

Location

Eurofins Optimed

Gières, 38610, France

Location

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Peripheral Nervous System DiseasesOsteoarthritisPain

Interventions

Blood Specimen CollectionGenotype

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesGenetic Phenomena

Study Officials

  • Alvaro Pereira

    Tools4Patient

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2016

First Posted

December 12, 2016

Study Start

February 8, 2017

Primary Completion

October 5, 2017

Study Completion

October 5, 2017

Last Updated

May 8, 2019

Record last verified: 2019-05

Locations

BE(1)FR(3)