Clinical trial · Interventional
Plasmatic L-AScorbic Acid in MYelodyplastic Syndroms and Controls
Kinetics of the Plasmatic Concentration of L-Ascorbic Acid in Patient With Myelodysplastic Syndromes and Control Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Secondary Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of life questionnaire | Other | — | UNRESOLVED |
| Samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Patients with MDS at diagnosis
- description
- 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
- interventionNames
- Other: Samples
- Other: Quality of life questionnaire
- type
- OTHER
- label
- Patients with MDS in treatment
- description
- 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
- interventionNames
- Other: Samples
- Other: Quality of life questionnaire
- type
- OTHER
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDDas A, Dey N, Ghosh A, Das T, Chatterjee IB. NAD(P)H: quinone oxidoreductase 1 deficiency conjoint with marginal vitamin C deficiency causes cigarette smoke induced myelodysplastic syndromes. PLoS One. 2011;6(5):e20590. doi: 10.1371/journal.pone.0020590. Epub 2011 May 31. PMID 21655231
- BACKGROUNDGhoti H, Amer J, Winder A, Rachmilewitz E, Fibach E. Oxidative stress in red blood cells, platelets and polymorphonuclear leukocytes from patients with myelodysplastic syndrome. Eur J Haematol. 2007 Dec;79(6):463-7. doi: 10.1111/j.1600-0609.2007.00972.x. Epub 2007 Nov 1. PMID 17976187
- BACKGROUNDHole PS, Darley RL, Tonks A. Do reactive oxygen species play a role in myeloid leukemias? Blood. 2011 Jun 2;117(22):5816-26. doi: 10.1182/blood-2011-01-326025. Epub 2011 Mar 11. PMID 21398578
- BACKGROUNDChung YJ, Robert C, Gough SM, Rassool FV, Aplan PD. Oxidative stress leads to increased mutation frequency in a murine model of myelodysplastic syndrome. Leuk Res. 2014 Jan;38(1):95-102. doi: 10.1016/j.leukres.2013.07.008. Epub 2013 Aug 16. PMID 23958061
- BACKGROUNDLevine M, Rumsey SC, Daruwala R, Park JB, Wang Y. Criteria and recommendations for vitamin C intake. JAMA. 1999 Apr 21;281(15):1415-23. doi: 10.1001/jama.281.15.1415. PMID 10217058
- BACKGROUNDPark CH. Vitamin C in leukemia and preleukemia cell growth. Prog Clin Biol Res. 1988;259:321-30. PMID 3362876
- BACKGROUNDPark CH, Kimler BF. Growth modulation of human leukemic, preleukemic, and myeloma progenitor cells by L-ascorbic acid. Am J Clin Nutr. 1991 Dec;54(6 Suppl):1241S-1246S. doi: 10.1093/ajcn/54.6.1241s. PMID 1962577
- BACKGROUNDPark CH, Kimler BF, Bodensteiner D, Lynch SR, Hassanein RS. In vitro growth modulation by L-ascorbic acid of colony-forming cells from bone marrow of patients with myelodysplastic syndromes. Cancer Res. 1992 Aug 15;52(16):4458-66.