Myelodysplastic SyndromePLASMYCNCT02809222
Plasmatic L-AScorbic Acid in MYelodyplastic Syndroms and Controls
A study testing Samples and Quality of life questionnaire in people with Myelodysplastic Syndrome and Secondary Acute Myeloid Leukemia, run by University Hospital, Tours at 2 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myelodysplastic Syndrome, Secondary Acute Myeloid Leukemia
- What is being tested?
- Samples and Quality of life questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Oct 2016to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
- Age ≥ 60 years
- Patient affiliated to social security scheme
- Informed consent signed by the patient
Who cannot join
- 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
- Patients MDS "in treatment" group selection criteria:
Show all 16Show fewer
- 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
- Healthy volunteers group selection 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinical Research Center, University Hospital, Tours
Tours, 37044
Department of Haematology and Cell Therapy, University Hospital, Tours
Tours, 3704
About this study
Official title: 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.
Read the 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.
- Being tested
- Samples, Quality of life questionnaire
- Keywords
- Myelodysplastic syndrome, Ascorbic acid, Oxidative stress, Preleukemia
- Medical subject headings
- Myelodysplastic Syndromes, Preleukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesOther
Blood samples
Quality of life questionnaireOther
Also called EORTC QLQ-C30
Questionnaire to assess the quality of life of cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with MDS at diagnosis | Other | 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 Receives: Other: Samples; Other: Quality of life questionnaire |
| Patients with MDS in treatment | Other | 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 Receives: Other: Samples; Other: Quality of life questionnaire |
| Healthy volunteers | Other | The intervention, specific to the study, is to take blood samples on patients healthy volunteers. Receives: Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic ascorbic acid concentration at baseline
For all groups: Plasmatic ascorbic acid concentration at first visit (0 month)
Measured: month 0
Secondary outcomes (10)
Plasmatic ascorbic acid concentration during follow-up
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
Measured: at 3 months, 6 months and 12 months
Plasmatic antioxidants concentrations
For all groups: Plasmatic antioxidants concentrations at 0 months, 6 months and 12 months
Measured: at 0 months, 6 months and 12 months
Collection of plasma
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
Measured: at 0 month, 3 months, 6 months and 12 months
Complete blood count and blood blasts cells
For patients MDS groups: Complete blood count and blood blasts cells at 0 month, 3 months, 6 months and 12 months
Measured: at 0 month, 3 months, 6 months and 12 months
Polyunsaturated fatty acids
For patients MDS groups: Polyunsaturated fatty acids at 0 month, 3 months, 6 months and 12 months
Measured: at 0 month, 3 months, 6 months and 12 months
Plasmatic ascorbic acid concentration and number of adverse events
For patients MDS groups: Plasmatic ascorbic acid concentration at 3 months, 6 months and 12 months and number of adverse events during follow-up
Measured: at 3 months, 6 months and 12 months
Oxidative stress parameters and number of adverse events
For patients MDS groups: Oxidative stress parameters at 3 months, 6 months and 12 months and number of adverse events during follow-up
Measured: at 3 months, 6 months and 12 months
Plasmatic ascorbic acid concentration and parameters of iron metabolism
For patients MDS groups: Plasmatic ascorbic acid concentration and parameters of iron metabolism at 0 month and 12 months
Measured: at 0 month and 12 months
Plasmatic ascorbic acid concentration and quality of life
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
Measured: at 0 month, 3 months, 6 months and 12 months
Collection of frozen cells
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.
Measured: 0 month and in case of evolution of the disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start25 Oct 2016
- Primary completion3 Mar 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Tours Autogreffe, Novartis
- Responsible party
- Sponsor
- Investigators
- Emmanuel GYAN, MD,PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809222
- Sponsor's protocol ID
- PHAO16-EG/PLASMYC
- Other IDs
- 2016-A00539-42
- Acronym
- PLASMYC
- Status last verified
- Apr 2021
- First submitted
- 17 Jun 2016
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Das 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.
PubMed 21655231Ghoti 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.
PubMed 17976187Hole 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.
PubMed 21398578Chung 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.
PubMed 23958061Levine 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.
PubMed 10217058Park CH. Vitamin C in leukemia and preleukemia cell growth. Prog Clin Biol Res. 1988;259:321-30.
PubMed 3362876Park 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.
PubMed 1962577Park 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.
PubMed 1643638Park CH, Kimler BF, Yi SY, Park SH, Kim K, Jung CW, Kim SH, Lee ER, Rha M, Kim S, Park MH, Lee SJ, Park HK, Lee MH, Yoon SS, Min YH, Kim BS, Kim JA, Kim WS. Depletion of L-ascorbic acid alternating with its supplementation in the treatment of patients with acute myeloid leukemia or myelodysplastic syndromes. Eur J Haematol. 2009 Aug;83(2):108-18. doi: 10.1111/j.1600-0609.2009.01252.x. Epub 2009 Mar 5.
PubMed 19284416Parker JE, Fishlock KL, Mijovic A, Czepulkowski B, Pagliuca A, Mufti GJ. 'Low-risk' myelodysplastic syndrome is associated with excessive apoptosis and an increased ratio of pro- versus anti-apoptotic bcl-2-related proteins. Br J Haematol. 1998 Dec;103(4):1075-82. doi: 10.1046/j.1365-2141.1998.01114.x.
PubMed 9886323Parker JE, Mufti GJ, Rasool F, Mijovic A, Devereux S, Pagliuca A. The role of apoptosis, proliferation, and the Bcl-2-related proteins in the myelodysplastic syndromes and acute myeloid leukemia secondary to MDS. Blood. 2000 Dec 1;96(12):3932-8.
PubMed 11090080Saito N, Miyamoto M, Gotoh U, Yoshitomi S. Effect of biscoclaurine alkaloids, prednisolone and ascorbic acid on myelodysplastic syndrome with pancytopenia: a case report. Eur J Haematol. 2000 Jan;64(1):61-5. doi: 10.1034/j.1600-0609.2000.9l036.x. No abstract available.
PubMed 10680708Welch JS, Klco JM, Gao F, Procknow E, Uy GL, Stockerl-Goldstein KE, Abboud CN, Westervelt P, DiPersio JF, Hassan A, Cashen AF, Vij R. Combination decitabine, arsenic trioxide, and ascorbic acid for the treatment of myelodysplastic syndrome and acute myeloid leukemia: a phase I study. Am J Hematol. 2011 Sep;86(9):796-800. doi: 10.1002/ajh.22092. Epub 2011 Aug 3. No abstract available.
PubMed 21815182
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of the Plasmatic Concentration of L-Ascorbic Acid in Patient With Myelodysplastic Syndromes and Control Subjects
- ClinicalTrials.gov ID
- NCT02809222
- Acronym / sponsor ID
- PLASMYC / PHAO16-EG/PLASMYC
- Keywords
- Myelodysplastic syndrome, Ascorbic acid, Oxidative stress, Preleukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Tours Autogreffe, Novartis
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with MDS at diagnosis | Other | Other: Samples, Other: Quality of life questionnaireThe 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 |
| Patients with MDS in treatment | Other | Other: Samples, Other: Quality of life questionnaireThe 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 |
| Healthy volunteers | Other | Other: SamplesThe intervention, specific to the study, is to take blood samples on patients healthy volunteers. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 60 years
- Patient affiliated to social security scheme
- Informed consent signed by the patient
Key exclusion criteria (16 listed)
- Patients MDS "in treatment" group selection criteria:
- Healthy volunteers group selection 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplesBlood samples | Other | Healthy volunteers, Patients with MDS at diagnosis, Patients with MDS in treatment |
| Quality of life questionnaireAlso: EORTC QLQ-C30Questionnaire to assess the quality of life of cancer patients | Other | Patients with MDS at diagnosis, Patients with MDS in treatment |
Primary outcome
Plasmatic ascorbic acid concentration at baseline
Time frame: month 0
For all groups: Plasmatic ascorbic acid concentration at first visit (0 month)
10 secondary outcomes
Plasmatic ascorbic acid concentration during follow-up
Time frame: at 3 months, 6 months and 12 months
Plasmatic antioxidants concentrations
Time frame: at 0 months, 6 months and 12 months
Collection of plasma
Time frame: 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
Polyunsaturated fatty acids
Time frame: 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
Oxidative stress parameters and number of adverse events
Time frame: 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
Plasmatic ascorbic acid concentration and quality of life
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Background: PubMed 21655231Das 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.
- Background: PubMed 17976187Ghoti 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.
- Background: PubMed 21398578Hole 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.
- Background: PubMed 23958061Chung 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.
- Background: PubMed 10217058Levine 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.
- Background: PubMed 3362876Park CH. Vitamin C in leukemia and preleukemia cell growth. Prog Clin Biol Res. 1988;259:321-30.
- Background: PubMed 1962577Park 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.
- Background: PubMed 1643638Park 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.
- Background: PubMed 19284416Park CH, Kimler BF, Yi SY, Park SH, Kim K, Jung CW, Kim SH, Lee ER, Rha M, Kim S, Park MH, Lee SJ, Park HK, Lee MH, Yoon SS, Min YH, Kim BS, Kim JA, Kim WS. Depletion of L-ascorbic acid alternating with its supplementation in the treatment of patients with acute myeloid leukemia or myelodysplastic syndromes. Eur J Haematol. 2009 Aug;83(2):108-18. doi: 10.1111/j.1600-0609.2009.01252.x. Epub 2009 Mar 5.
- Background: PubMed 9886323Parker JE, Fishlock KL, Mijovic A, Czepulkowski B, Pagliuca A, Mufti GJ. 'Low-risk' myelodysplastic syndrome is associated with excessive apoptosis and an increased ratio of pro- versus anti-apoptotic bcl-2-related proteins. Br J Haematol. 1998 Dec;103(4):1075-82. doi: 10.1046/j.1365-2141.1998.01114.x.
- Background: PubMed 11090080Parker JE, Mufti GJ, Rasool F, Mijovic A, Devereux S, Pagliuca A. The role of apoptosis, proliferation, and the Bcl-2-related proteins in the myelodysplastic syndromes and acute myeloid leukemia secondary to MDS. Blood. 2000 Dec 1;96(12):3932-8.
- Background: PubMed 10680708Saito N, Miyamoto M, Gotoh U, Yoshitomi S. Effect of biscoclaurine alkaloids, prednisolone and ascorbic acid on myelodysplastic syndrome with pancytopenia: a case report. Eur J Haematol. 2000 Jan;64(1):61-5. doi: 10.1034/j.1600-0609.2000.9l036.x. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel GYAN, MD,PhD principal investigator
University Hospital, Tours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samples and Quality of life questionnaire in people with Myelodysplastic Syndrome and Secondary Acute Myeloid Leukemia, run by University Hospital, Tours at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmatic ascorbic acid concentration at baseline (time frame: month 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809222, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.