Stem Cell TransplantELDERGRAFNCT04375579
Assessment of Elderly Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of Stem Cell Transplant, run by Assistance Publique - Hôpitaux de Paris at 18 sites in France.
Trial summary
Patients older than 60 years are more and more transplanted. Comprehensive geriatric assessment (CGA) have been developed and are currently used in patients with cancer, it has been correlated with the prognosis. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stem Cell Transplant
- What is being tested?
- Comprehensive geriatric assessment (CGA)
- How many people
- 205 participants
- Where
- 18 sitesFrance
- Study dates
- 3 Jul 2020to 17 Oct 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 60 years who received an allogeneic hematopoietic stem cell transplantation HSCT
Who may be able to join
- 60 years or more at time of transplantation
- Patient receiving a hematopoietic stem cell allograft for myeloid hemopathy (myeloid acute leukemia, myelodysplastic syndrome, Myeloproliferative neoplasm) or for an Acute lymphoblastic leukemia
- No opposition to participate
Who cannot join
- Patient opposed to the protocol
- Vulnerable patients protected by curatorship or administrative supervision
- Patients not covered by a social security scheme
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU Amiens
Amiens
CHU Angers
Angers
CHU Besancon
Besançon
CHU Bordeaux
Bordeaux
CHU Caen
Caen
CHU Clermont-Ferrand
Clermont-Ferrand
CHU Grenoble
Grenoble
CHRU Lille
Lille
CHU Limoges
Limoges
CHU Lyon
Lyon
CHU Montpellier
Montpellier
CHRU Nancy
Nancy
CHU Nantes
Nantes
CHU Nice
Nice
Hopital de la Pitié Salpetrière
Paris
Hopital Necker
Paris
Hopital Saint Louis
Paris
CHU Toulouse
Toulouse
About this study
Official title: Multi-domain Assessment and Quality of Life in Patients Older Than 60 Years Receiving an Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Patients older than 60 years are more and more transplanted. Comprehensive geriatric assessment (CGA) have been developed and are currently used in patients with cancer, it has been correlated with the prognosis. There is still few data in transplanted patients and the aim of this study is to assess these patients before and after transplantation in order to monitor their general health and quality of life (QOF) and correlate them to the prognostic.
- Conditions
- Stem Cell Transplant
- Being tested
- Comprehensive geriatric assessment (CGA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive geriatric assessment (CGA)Other
Questionnaires on nutritional status, autonomy and quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: at one year post allogeneic hematopoietic stem cell transplantation
Secondary outcomes (27)
Overall survival
Measured: at two years post allogeneic hematopoietic stem cell transplantation
Morbidity Index
Measured: at one year
Morbidity Index
Measured: at two years
Survival without disease and chronic graft-versus-host disease
Measured: at one year post allogeneic hematopoietic stem cell transplantation
Survival without disease and chronic graft-versus-host disease
Measured: at two years post allogeneic hematopoietic stem cell transplantation
Proportion of patient with Viral Reactivation
Reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) virus
Measured: at one year
Acute graft-versus-host disease
Measured: at 100 days
Chronic graft-versus-host disease
Measured: at 1 year
Chronic graft-versus-host disease
Measured: at 2 years
Incidence of relapse
Measured: at two years
Walk test
Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions.
Measured: at day 100
Walk test
Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions.
Measured: at one year
Walk test
Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions.
Measured: at two years
Nutritional score
Nutrional score will be assessed using the simple evaluation of food intake (SEFI scale). The minimum value is 0 and the maximum is 10. The highest score mean that the patient's food intake are the same as usual.
Measured: at day 100
Nutritional score
Nutrional score will be assessed using the simple evaluation of food intake (SEFI scale). The minimum value is 0 and the maximum is 10. The highest score mean that the patient's food intake are the same as usual.
Measured: at one year
Nutritional score
Nutrional score will be assessed using the simple evaluation of food intake (SEFI scale). The minimum value is 0 and the maximum is 10. The highest score mean that the patient's food intake are the same as usual.
Measured: at two years
Karnofsky index
The Karnofsky index is a synthetic indicator of the overall health status measuring, on a scale from 0 (death) to 100 (full health)
Measured: at day 100
Karnofsky index
The Karnofsky index is a synthetic indicator of the overall health status measuring, on a scale from 0 (death) to 100 (full health)
Measured: at one year
Evaluation of autonomy
Autonomy will be evaluated using ADL and IADL score. Instrumental activities of daily living - global score range from 0 to 4.
Measured: at one year
Evaluation of Quality of life
Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
EORTC QLQ-C30 Scoring Manual. Fayers PM et al. on behalf of the EORTC Quality of Life Group. EORTC, 2001. ISBN: 2-9300.
Measured: at one year
Length of hospitalisation initially
Measured: at two years
Length of hospitalisation during the first year after graft
Measured: Up to one year
Questionnaire completion rate
Measured: At 2 years
Length of pre-grafting visit
Measured: At 2 years
Length of D100 visit
Measured: At 2 years
Length of 1year visit
Measured: At 2 years
Length of 2 years visit
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start3 Jul 2020
- Primary completion17 Oct 2023
- Study completion17 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375579
- Sponsor's protocol ID
- APHP200084
- Acronym
- ELDERGRAF
- Status last verified
- Jun 2024
- First submitted
- 28 Apr 2020
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-domain Assessment and Quality of Life in Patients Older Than 60 Years Receiving an Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- ClinicalTrials.gov ID
- NCT04375579
- Acronym / sponsor ID
- ELDERGRAF / APHP200084
- Conditions
- Stem Cell Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2024 (estimated)
- First posted
- 5 May 2020 (actual)
- 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.
Patients older than 60 years are more and more transplanted. Comprehensive geriatric assessment (CGA) have been developed and are currently used in patients with cancer, it has been correlated with the prognosis. There is still few data in transplanted patients and the aim of this study is to assess these patients before and after transplantation in order to monitor their general health and quality of life (QOF) and correlate them to the prognostic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 60 years who received an allogeneic hematopoietic stem cell transplantation HSCT
Key inclusion criteria (3 listed)
- 60 years or more at time of transplantation
- Patient receiving a hematopoietic stem cell allograft for myeloid hemopathy (myeloid acute leukemia, myelodysplastic syndrome, Myeloproliferative neoplasm) or for an Acute lymphoblastic leukemia
- No opposition to participate
Key exclusion criteria (3 listed)
- Patient opposed to the protocol
- Vulnerable patients protected by curatorship or administrative supervision
- Patients not covered by a social security scheme
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 |
|---|---|---|
| Comprehensive geriatric assessment (CGA)Questionnaires on nutritional status, autonomy and quality of life | Other | – |
Primary outcome
Overall survival
Time frame: at one year post allogeneic hematopoietic stem cell transplantation
27 secondary outcomes
Overall survival
Time frame: at two years post allogeneic hematopoietic stem cell transplantation
Morbidity Index
Time frame: at one year
Morbidity Index
Time frame: at two years
Survival without disease and chronic graft-versus-host disease
Time frame: at one year post allogeneic hematopoietic stem cell transplantation
Survival without disease and chronic graft-versus-host disease
Time frame: at two years post allogeneic hematopoietic stem cell transplantation
Proportion of patient with Viral Reactivation
Time frame: at one year
Acute graft-versus-host disease
Time frame: at 100 days
Chronic graft-versus-host disease
Time frame: at 1 year
Chronic graft-versus-host disease
Time frame: at 2 years
Incidence of relapse
Time frame: at two years
Walk test
Time frame: at day 100
Walk test
Time frame: at one year
Walk test
Time frame: at two years
Nutritional score
Time frame: at day 100
Nutritional score
Time frame: at one year
Nutritional score
Time frame: at two years
Karnofsky index
Time frame: at day 100
Karnofsky index
Time frame: at one year
Evaluation of autonomy
Time frame: at one year
Evaluation of Quality of life
Time frame: at one year
Length of hospitalisation initially
Time frame: at two years
Length of hospitalisation during the first year after graft
Time frame: Up to one year
Questionnaire completion rate
Time frame: At 2 years
Length of pre-grafting visit
Time frame: At 2 years
Length of D100 visit
Time frame: At 2 years
Length of 1year visit
Time frame: At 2 years
Length of 2 years visit
Time frame: At 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplant, run by Assistance Publique - Hôpitaux de Paris at 18 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Results are not available in the source record.
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?
Overall survival (time frame: at one year post allogeneic hematopoietic stem cell transplantation). 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 26 Jun 2024.