Myelodysplastic SyndromesPREDICTORNCT02689622
PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
A study testing research of disease-related factors, research of comorbidities and physical performance in people with Myelodysplastic Syndromes, run by University Hospital, Toulouse at 31 sites in 2 countries.
Trial summary
No prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. Patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- research of disease-related factors, research of comorbidities and physical performance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 20 Apr 2016to Jan 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of HR-MDS inferior to 6 weeks,
- No treatment received before inclusion,
- IPSS superior to 1 (intermediate 2 and high risk IPSS categories),
- Social system affiliation,
- Informed consent signed.
Who cannot join
- Patient eligibility to stem cell transplantation,
- IPSS inferior or egal 1 (low or intermediate 1 IPSS),
- Concomitant investigational trial participation, which could interfere,
- Patients under legal protection.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
France30 sites
Hôpital Sud
Amiens
Chu Angers
Angers
CH Annecy
Annecy
CH Henri Duffaut
Avignon
CH Blois
Blois
CH Boulogne sur mer
Boulogne-sur-Mer
CH Sud Francillien
Corbeil-Essonnes
CHU Henri Mondor
Créteil
CHU Albert Michallon
Grenoble
CH Versailles
Le Chesnay
CH du Mans
Le Mans
CH de Lens
Lens
Hôpital saint vincent de paul - Institut Catholique
Lille
CHU Limoges
Limoges
Ch Lyon Sud
Lyon
Institut Paoli Calmette
Marseille
CH de Meaux
Meaux
Chu Brabois
Nancy
Chu Hotel Dieu
Nantes
Hôpital de l'archet I
Nice
Hôpital COCHIN
Paris
Hôpital St Louis
Paris
CH Saint Jean
Perpignan
CHU Poitiers
Poitiers
CH René Dubos
Pontoise
Hôpital Pontchaillou
Rennes
Centre Henri Becquerel
Rouen
CH St Malo
St-Malo
CHU Toulouse
Toulouse
Hôpital Bretonneau
Tours
About this study
Official title: Best PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
No prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. Patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. The impact on overall survival of all of these factors was recognized in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes (HR-MDS). Therefore this information could be crucial to better select geriatric assessment domains relevant for the prediction and to recommend simplified tool after stratification of geriatric assessment domains thanks to their predictive value.
The main hypothesis is that patient-related factors will have a better capacity to predict survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and that the predictive value will be different among assessment tools which allows a selection of reduced number of tools for clinical use.
Read more
To best knowledge estimation of predictive value of geriatric assessment tools remains unknown and explains why no standardization of practice exists. In testing all tools at the same cohort of patients allows to compare different tools and to define minimal and optimal geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will allow in a second time to measure the impact of the use of this geriatric standardized evaluation by comparing patients'care and prognosis according to the use or not by the doctors of the new scores.
Research outcomes are various medical, economic and ethic. Medical because decision-making will be improved with simplified geriatric assessment; economic because a better knowledge of geriatric assessment will improve treatment toxicity prevention and decrease treatment costs. Ethic will be associated with this project because a better knowledge of geriatric assessment tools to predict survival and tolerance treatment could improve the choice of best supportive care if prognosis markers are not favorable to active therapy. This project could induce important modification of practice in this area to an improved personalized treatment and simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- research of disease-related factors, research of comorbidities, physical performance
- Keywords
- Hematology, Elderly, High Risk Myelodysplastic Syndrome
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
research of disease-related factorsOther
included in IPSS and IPSS-R, lactate dehydrogenase, ferritin level, transfusion- dependence, molecular markers as genes mutations
research of comorbiditiesOther
HCT-Comorbidity Index, MDS-Comorbidity Index, Adult Comorbidity Evaluation-27, Cumulative Illness Rating Scale-G
physical performanceOther
Activities of Daily Living and physical performance
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of disease prognostic factors | Experimental | Research of disease-related factors, research of comorbidities, geriatric assessment (Mini Mental Status Examination (MMSE), Geriatric Depression Scale-15, Mini Nutritional Assessment, Short Physical Performance Battery, grip strength, Fried criteria, Activities of Daily Living (ADL), Instrumental-ADL, G8, self-reported health status, quality of life Quality of Life Questionnaire-C30, Elderly Cancer Patients-14, EQ5D) at inclusion. At 3 months ADL and physical performance. Grade 3/4 toxicities and serious adverse events will be assessed during 6 months after inclusion (using NCI-COMMON TERMINOLOGY CRITERIA version 2.0) whatever treatment type (chemotherapy, supportive care). Receives: Other: research of disease-related factors; Other: research of comorbidities; Other: physical performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPPS score
Measured: 1 year
Secondary outcomes (2)
percentage of patients who had adverse events grade 3 or higher or having a serious adverse event
Measured: 6 months
difference of geriatric assessment score between day 1 and 3 month
Measured: day 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start20 Apr 2016
- Primary completion31 Jan 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Odile BEYNE-RAUZY, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689622
- Sponsor's protocol ID
- 14 7429 07
- Acronym
- PREDICTOR
- Status last verified
- Jul 2020
- First submitted
- 14 Dec 2015
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
- ClinicalTrials.gov ID
- NCT02689622
- Acronym / sponsor ID
- PREDICTOR / 14 7429 07
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Hematology, Elderly, High Risk Myelodysplastic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 20 Apr 2016 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 24 Feb 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.
No prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. Patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. The impact on overall survival of all of these factors was recognized in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes (HR-MDS). Therefore this information could be crucial to better select geriatric assessment domains relevant for the prediction and to recommend simplified tool after stratification of geriatric assessment domains thanks to their predictive value.
The main hypothesis is that patient-related factors will have a better capacity to predict survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and that the predictive value will be different among assessment tools which allows a selection of reduced number of tools for clinical use.
To best knowledge estimation of predictive value of geriatric assessment tools remains unknown and explains why no standardization of practice exists. In testing all tools at the same cohort of patients allows to compare different tools and to define minimal and optimal geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will allow in a second time to measure the impact of the use of this geriatric standardized evaluation by comparing patients'care and prognosis according to the use or not by the doctors of the new scores.
Research outcomes are various medical, economic and ethic. Medical because decision-making will be improved with simplified geriatric assessment; economic because a better knowledge of geriatric assessment will improve treatment toxicity prevention and decrease treatment costs. Ethic will be associated with this project because a better knowledge of geriatric assessment tools to predict survival and tolerance treatment could improve the choice of best supportive care if prognosis markers are not favorable to active therapy. This project could induce important modification of practice in this area to an improved personalized treatment and simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of disease prognostic factors | Experimental | Other: research of disease-related factors, Other: research of comorbidities, Other: physical performanceResearch of disease-related factors, research of comorbidities, geriatric assessment (Mini Mental Status Examination (MMSE), Geriatric Depression Scale-15, Mini Nutritional Assessment, Short Physical Performance Battery, grip strength, Fried criteria, Activities of Daily Living (ADL), Instrumental-ADL, G8, self-reported health status, quality of life Quality of Life Questionnaire-C30, Elderly Cancer Patients-14, EQ5D) at inclusion. At 3 months ADL and physical performance. Grade 3/4 toxicities and serious adverse events will be assessed during 6 months after inclusion (using NCI-COMMON TERMINOLOGY CRITERIA version 2.0) whatever treatment type (chemotherapy, supportive care). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Diagnosis of HR-MDS inferior to 6 weeks,
- No treatment received before inclusion,
- IPSS superior to 1 (intermediate 2 and high risk IPSS categories),
- Social system affiliation,
- Informed consent signed.
Key exclusion criteria (4 listed)
- Patient eligibility to stem cell transplantation,
- IPSS inferior or egal 1 (low or intermediate 1 IPSS),
- Concomitant investigational trial participation, which could interfere,
- Patients under legal protection.
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 |
|---|---|---|
| research of disease-related factorsincluded in IPSS and IPSS-R, lactate dehydrogenase, ferritin level, transfusion- dependence, molecular markers as genes mutations | Other | Evaluation of disease prognostic factors |
| research of comorbiditiesHCT-Comorbidity Index, MDS-Comorbidity Index, Adult Comorbidity Evaluation-27, Cumulative Illness Rating Scale-G | Other | Evaluation of disease prognostic factors |
| physical performanceActivities of Daily Living and physical performance | Other | Evaluation of disease prognostic factors |
Primary outcome
IPPS score
Time frame: 1 year
2 secondary outcomes
percentage of patients who had adverse events grade 3 or higher or having a serious adverse event
Time frame: 6 months
difference of geriatric assessment score between day 1 and 3 month
Time frame: day 1 and 3 months
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 30 Jul 2020.
- 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.
Odile BEYNE-RAUZY, MD principal investigator
University Hospital, Toulouse
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing research of disease-related factors, research of comorbidities and physical performance in people with Myelodysplastic Syndromes, run by University Hospital, Toulouse at 31 sites in 2 countries.
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 5 inclusion and 4 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 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Monaco. 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?
IPPS score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.