An observational study in Polycythemia Vera and Essential Thrombocythemia, sponsored by University Hospital, Bordeaux. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-19.
Sponsored by University Hospital, Bordeaux · Observational
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).
The recent discovery of calreticulin mutations in myeloproliferative neoplasms point to the unexpected role of the endoplasmic reticulum biology in the pathophysiology in these diseases. Otherwise, the association of endoplasmic reticulum stress with solid cancers, in particular in resistance to chemotherapy, is well documented, contrary to hematological malignancies. The study aims to evaluate endoplasmic reticulum stress markers as predictors for the response to hydroxyurea in polycythemia vera and essential thrombocythemia patients. The main objective is 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. This is an observational retrospective study.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 148 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Polycythemia Vera or Essential Thrombocythemia
Diagnosis criteria of PV :
WHO criteria of PV with :
Diagnosis criteria of ET :
Exclusion Criteria:
In absence of clonality marker, presence of secondary cause of :
Thrombocytosis :
Polycythemia :
Increased or normal level of EPO in context of :
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
RNA sample of total leukocytes before start of treatment
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
Time frame: After 6 months of treatment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Bordeaux