NCT03102905

Brief Summary

To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies presenting an exanthema. This will make it possible to evaluate the prevalence of the positivity of this PCR in the skin. Then the investigator can investigate whether there is an association between the positivity of HHV6 PCR in the blood and / or skin and the viral etiology of the exanthema. If this association exists, it will make it possible to improve the diagnosis in the context of the exanthema and thus to improve the therapeutic management of these patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 13, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2017

Completed
Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

March 31, 2017

Last Update Submit

March 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.

    1 day

Interventions

To evaluate the prevalence of the positivity of HHV6 PCR in the skin, during the exanthema in patients hospitalized for haemopathy.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient hospitalized in the Clinical Hematology and Cellular Therapy department of the CHU Amiens-Picardie between 01/01/2011 and 31/01/2016

You may qualify if:

  • Supported for any type of hemopathy.
  • Allograft, autografted or ungrafted haematopoietic stem cells
  • Having presented an exanthema during hospitalization, for which a cutaneous biopsy had been performed
  • Having had a blood test of the HHV6 virus by PCR at least within the previous 40 days or following the rash.
  • Age greater than or equal to 18 years
  • Patient informed of the protocol by post, not having refused within one month of sending the said courier.

You may not qualify if:

  • Patient who refused the search.
  • Patient whose HHV6 PCR in the blood was carried out at a distance of more than 40 days from the skin biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Exanthema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 6, 2017

Study Start

December 13, 2016

Primary Completion

June 13, 2017

Study Completion

June 13, 2017

Last Updated

April 6, 2017

Record last verified: 2017-03

Locations