NCT03750994

Brief Summary

To evaluate the impact of innovative molecular diagnostics on the clinical management of patients with haematological malignancies via updated Appropriate-Prescribing-Guides including Next-Generation Sequencing (NGS) panels, facilitated therapeutic orientation, and optimised use of costly novel therapeutics and risk-adapted treatment. A micro-costing approach will be used to develop flat fee tarifs for NGS analyses.

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
3,960

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

26 active sites

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

First Submitted

Initial submission to the registry

August 11, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

August 11, 2017

Last Update Submit

November 21, 2018

Conditions

Haematological Malignancy

Outcome Measures

Primary Outcomes (6)

  • Percentage of Next Generation Sequencing (NGS) tests that have a clinical impact for the patient for five hematological malignancies.

    2 years

  • Percentage of Next Generation Sequencing (NGS) that are from the oncologists internal to the platform versus external centres.

    2 years

  • Average time in days between the Next Generation Sequencing (NGS) prescription being issued and the results being rendered to the clinician.

    2 years

  • Percentage of prescriptions for diagnostics, prognostic, theranostics or treatment response

    2 years

  • Percentage of the genetic targets that are analysed for research purposes versus immediate clinical utility for the patient.

    2 years

  • Percentage of patients prescribed the Next Generation Sequencing (NGS) at the diagnostic stage or before second (or higher) line treatment.

    2 years

Eligibility Criteria

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

Patients referred for molecular diagnosis at one of the certified molecular onco-haematology platforms in France.

You may qualify if:

  • Patients with haematological malignancies referred for molecular diagnosis workup. RuBIH2 will focus on 5 clinical situations in onco-haematology:
  • Myelodysplasia (MDS)
  • Acute lymphocytic leukemia (T) (ALL)
  • Lymphoproliferative disorders (LPD)
  • Acute myeloblastic leukemia (AML)
  • Myeloproliferative disorders (MPD)

You may not qualify if:

  • Other haematological diseases not included in the list above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Centre hospitalier régional universitaire de Lille

Lille, Hauts-de-France, 59000, France

RECRUITING

CHU Angers

Angers, France

RECRUITING

Hôpital Avicenne AP-HP

Bobigny, France

RECRUITING

CHU de Bordeaux

Bordeaux, France

RECRUITING

CHRU Brest

Brest, France

RECRUITING

CHU Estaing

Clermont-Ferrand, France

RECRUITING

Hôpital Henri Mondor AP-HP

Créteil, France

RECRUITING

CHRU Dijon Bourgogne

Dijon, France

RECRUITING

CHU Limoges

Limoges, France

RECRUITING

CHU Lyon Sud Pierre Bénite

Lyon, France

RECRUITING

CHU Montpellier

Montpellier, France

RECRUITING

CHU Hôtel Dieu

Nantes, France

RECRUITING

CHU Nice

Nice, France

RECRUITING

Hôpital Pitié-Salpêtrière AP-HP

Paris, 75004, France

RECRUITING

Hôpital Robert Debré

Paris, 75004, France

RECRUITING

Hôpital St Louis AP-HP

Paris, 75004, France

RECRUITING

Hôpital Cochin AP-HP

Paris, France

RECRUITING

Hôpital Necker AP-HP

Paris, France

RECRUITING

Hôpital Saint Antoine AP-HP

Paris, France

RECRUITING

CHU Robert Debré Reims

Reims, France

RECRUITING

CHU Pontchaillou

Rennes, France

RECRUITING

Centre Henri-Becquerel

Rouen, France

RECRUITING

Centre hospitalier universitaire de Saint-Étienne

Saint-Etienne, France

RECRUITING

Hôpitaux Universitaires Strasbourg

Strasbourg, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Claude Preudhomme, Professor

    DRCI AP-HP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claude Preudhomme, Professor

CONTACT

+ 33 3 20 44 47 82claude.preudhomme@chru-lille.fr

Elisabeth Macintyre, Professor

CONTACT

+ 33 1 44 49 49 47elizabeth.macintyre@aphp.fr

Study Design

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

Study Record Dates

First Submitted

August 11, 2017

First Posted

November 23, 2018

Study Start

October 18, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

FR(26)