Plasmatic L-AScorbic Acid in MYelodyplastic Syndroms and Controls (PLASMYC)

April 15, 2021 updated by: University Hospital, Tours

Kinetics of the Plasmatic Concentration of L-Ascorbic Acid in Patient With Myelodysplastic Syndromes and Control Subjects

Myelodysplastic syndromes (MDS) is a group of heterogeneous diseases characterised by the clonal evolution of dysplastic hematopoietic stem cells. This evolution is associated with accumulation of cytogenetic mutations which leads to acute myeloid leukaemia (AML). Evolution of MDS is also associated with increase of reactive oxygen species (ROS). The increase of ROS is associated with accumulation of cytogenetic mutations. Ascorbic acid (AA) is an actor of the regulation of the oxidative metabolism in the human body.

Studies showed that supplementation with AA can change the proliferation status of MDS cells. Adjuvant treatment with AA is associated with a beneficial effect on the evolution of MDS and AML. The present study aim at describing the variations of plasmatic ascorbic acid concentrations between healthy volunteers and patients with myelodysplastic syndromes advanced in their treatment or recently diagnosed during a follow-up of 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Myelodysplastic syndromes (MDS) is a group of heterogeneous life threatening diseases characterised by the clonal evolution of dysplastic myeloid hematopoietic stem cells. This evolution is initially associated with an excess of apoptosis followed by an excess of proliferation then, after accumulation of cytogenetic mutations, a transformation in acute myeloid leukaemia (AML) can appear. Evolution of MDS is also associated with increase of reactive oxygen species (ROS) . In MDS mice, perturbations of the metabolism of ROS is associated with increases in the number of cytogenetic mutations.

Ascorbic acid (AA) is an actor of the regulation of the oxidative metabolism in the human body. In vitro studies showed that supplementation with AA can change the proliferation status of MDS cells . Guinea pigs with a phenotype with excess of ROS supplemented with AA have less somatic mutations and less MDS. Adjuvant treatment with AA is associated with a beneficial effect on the evolution of MDS and AML.

To our knowledge no study have demonstrated the variations of the parameters of the oxidative metabolism during the evolution of MDS. The present study aim at describing the variations of plasmatic ascorbic acid concentrations between healthy volunteers and patients diagnosed with MDS in treatment or recently diagnosed during a follow-up of 12 months. During the follow-up a collection of plasma from volunteers and patients will be created for later analysis.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • Clinical Research Center, University Hospital, Tours
      • Tours, France, 3704
        • Department of Haematology and Cell Therapy, University Hospital, Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  1. Patients MDS "at diagnosis" group selection criteria

    Inclusion Criteria:

    • Diagnosis of myelodysplastic syndrome according to the 2008 WHO classification
    • Patient diagnosed for less than 4 months before inclusion
    • Patient untreated by other means than blood transfusions
    • Age ≥ 60 years
    • Patient affiliated to social security scheme
    • Informed consent signed by the patient

    Exclusion Criteria:

    • Previous allogenic stem cell transplantation
    • Patient with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
    • Active inflammatory disease
    • Patient under legal protection measure
    • Patient unwilling or who cannot submit to prospective biological follow-up

  2. Patients MDS "in treatment" group selection criteria:

    Inclusion Criteria:

    • Diagnosis of myelodysplastic syndrome according to the 2008 WHO classification
    • Patient not included in patients MDS "at diagnosis" group
    • Patient diagnosed for more than 12 months
    • Treated with hypomethylating agents and/or erythropoiesis-stimulating agents and/or blood transfusions.
    • Age ≥ 60 years
    • Patient affiliated to social security scheme
    • Informed consent signed by the patient

    Exclusion Criteria:

    • Previous allogenic stem cell transplantation
    • Patient with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
    • Active inflammatory disease
    • Patient under legal protection measure
    • Patient unwilling or who cannot submit to prospective biological follow-up
  3. Healthy volunteers group selection criteria:

Inclusion Criteria:

  • Age ≥ 60 years
  • Patient affiliated to social security scheme
  • Informed consent signed by the patient

Exclusion Criteria:

  • History of another primary malignancy that is currently clinically significant or currently requires active intervention
  • History of active inflammatory diseases
  • Volunteer under legal protection measure
  • Volunteer unwilling or who cannot submit to prospective biological follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with MDS at diagnosis
The intervention, specific to the study, is to take blood samples on patients with MDS at diagnosis. A quality of life questionnaire will also be used to monitor patients
Other: Samples
Blood samples
Other: Quality of life questionnaire
Questionnaire to assess the quality of life of cancer patients
Other Names:
  • EORTC QLQ-C30
Other: Patients with MDS in treatment
The intervention, specific to the study, is to take blood samples on patients with MDS receiving treatment. A quality of life questionnaire will also be used to monitor patients
Other: Samples
Blood samples
Other: Quality of life questionnaire
Questionnaire to assess the quality of life of cancer patients
Other Names:
  • EORTC QLQ-C30
Other: Healthy volunteers
The intervention, specific to the study, is to take blood samples on patients healthy volunteers.
Other: Samples
Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasmatic ascorbic acid concentration at baseline
Time Frame: month 0
For all groups: Plasmatic ascorbic acid concentration at first visit (0 month)
month 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasmatic ascorbic acid concentration during follow-up
Time Frame: at 3 months, 6 months and 12 months
For all groups: Plasmatic ascorbic acid concentrations at 6 months and 12 months visits with an extra plasmatic ascorbic acid concentrations at 3 months for patients MDS groups
at 3 months, 6 months and 12 months
Plasmatic antioxidants concentrations
Time Frame: at 0 months, 6 months and 12 months
For all groups: Plasmatic antioxidants concentrations at 0 months, 6 months and 12 months
at 0 months, 6 months and 12 months
Collection of plasma
Time Frame: at 0 month, 3 months, 6 months and 12 months
For all groups: Creation of a collection of plasma samples for later analysis at 0 month, 6 months and 12 months with an extra plasma sample at 3 months for patients MDS groups
at 0 month, 3 months, 6 months and 12 months
Complete blood count and blood blasts cells
Time Frame: at 0 month, 3 months, 6 months and 12 months
For patients MDS groups: Complete blood count and blood blasts cells at 0 month, 3 months, 6 months and 12 months
at 0 month, 3 months, 6 months and 12 months
Polyunsaturated fatty acids
Time Frame: at 0 month, 3 months, 6 months and 12 months
For patients MDS groups: Polyunsaturated fatty acids at 0 month, 3 months, 6 months and 12 months
at 0 month, 3 months, 6 months and 12 months
Plasmatic ascorbic acid concentration and number of adverse events
Time Frame: at 3 months, 6 months and 12 months
For patients MDS groups: Plasmatic ascorbic acid concentration at 3 months, 6 months and 12 months and number of adverse events during follow-up
at 3 months, 6 months and 12 months
Oxidative stress parameters and number of adverse events
Time Frame: at 3 months, 6 months and 12 months
For patients MDS groups: Oxidative stress parameters at 3 months, 6 months and 12 months and number of adverse events during follow-up
at 3 months, 6 months and 12 months
Plasmatic ascorbic acid concentration and parameters of iron metabolism
Time Frame: at 0 month and 12 months
For patients MDS groups: Plasmatic ascorbic acid concentration and parameters of iron metabolism at 0 month and 12 months
at 0 month and 12 months
Plasmatic ascorbic acid concentration and quality of life
Time Frame: at 0 month, 3 months, 6 months and 12 months
For patients MDS groups: Plasmatic ascorbic acid concentration and quality of life evaluated by the EORTC QLQ-C30 3rd version at 0 month, 3 months, 6 months and 12 months
at 0 month, 3 months, 6 months and 12 months
Collection of frozen cells
Time Frame: 0 month and in case of evolution of the disease
For patients MDS groups: Creation of a collection of frozen cells for DNA analysis at 0 month and in case of evolution of the disease.
0 month and in case of evolution of the disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

Novartis
Tours Autogreffe

Investigators

  • Principal Investigator: Emmanuel GYAN, MD,PhD, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2016

Primary Completion (Actual)

March 3, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 15, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHAO16-EG/PLASMYC
  • 2016-A00539-42 (Registry Identifier: IdRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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