NCT02823184

Brief Summary

The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

7 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

June 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

April 27, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2019

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

June 24, 2016

Last Update Submit

June 18, 2020

Conditions

Polycythemia VeraEssential Thrombocythemia

Keywords

Myeloproliferative neoplasmsEndoplasmic reticulum stress

Outcome Measures

Primary Outcomes (1)

  • To correlate endoplasmic reticulum stress (defined as splicing of XBP1 above 30%) to the rate of complete response after 6 months according to the 2009 ELN criteria

    After 6 months of treatment

Study Arms (1)

Patients

ET or PV patients diagnosed before acceleration phase and treated by hydroxyurea with a follow up period of at least 6 months following treatment start, with a RNA sample of total leukocytes before start of treatment available

Biological: RNA sample of total leukocytes before start of treatment

Interventions

RNA sample of total leukocytes before start of treatmentBIOLOGICAL

RNA sample of total leukocytes before start of treatment

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Polycythemia Vera or Essential Thrombocythemia

You may qualify if:

  • ET or PV patients diagnosed before acceleration phase and treated by hydroxyurea with a follow up period of at least 6 months following treatment start.
  • Diagnosis criteria of PV :
  • WHO criteria of PV with :
  • Acquired JAK2V617F mutation \> 5%
  • Absence of evident cause of secondary polycythemia
  • Diagnosis criteria of ET :
  • Platelet count \> 450 G/L
  • Absence of PV or Chronic Myeloid Leukemia
  • Bone marrow biopsy preferred but not necessary in absence of reactional causes (CRP and ferritin levels normal) and/or presence of acquired JAK2V617F, CALR exon 9 or MPL exon 10
  • Availability of RNA sample of total leukocytes before start of treatment.

You may not qualify if:

  • In absence of clonality marker, presence of secondary cause of :
  • Thrombocytosis :
  • Inflammatory syndrom (CRP or SV increased)
  • Iron deficiency (decreased ferritin level or increased soluble transferrin receptor level)
  • Polycythemia :
  • Increased or normal level of EPO in context of :
  • Hypoxia, respiratory insufficiency
  • Sleep apnea syndrome
  • Hyperaffin hemoglobin
  • Absence of treatment by hydroxyurea
  • Treatment by anagrelide, P32, pipobroman, interferon without subsequent hydroxyurea treatment.
  • Concommitant treatment by other cancer chemotherapy (in a context of solid cancer for example).
  • Diagnostic during transformation to acute leukemia
  • Treatment by hydroxyurea during less than 6 months
  • Bad observance of the cytotoxic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chu Angers

Angers, France

Location

Ch de La Cöte Basque

Bayonne, France

Location

Chu de Bordeaux

Bordeaux, France

Location

Crlcc Bergonie

Bordeaux, France

Location

Chu de Brest

Brest, France

Location

Ch de Dax

Dax, France

Location

Ch de Libourne

Libourne, France

Location

MeSH Terms

Conditions

Polycythemia VeraThrombocythemia, EssentialMyeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic Disorders

Study Officials

  • Olivier MANSIER, Doctor

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 24, 2016

First Posted

July 6, 2016

Study Start

April 27, 2017

Primary Completion

April 27, 2019

Study Completion

April 27, 2019

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)