NCT04375579

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

18 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 3, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

3.3 years

First QC Date

April 28, 2020

Last Update Submit

June 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    at one year post allogeneic hematopoietic stem cell transplantation

Secondary Outcomes (27)

  • Overall survival

    at two years post allogeneic hematopoietic stem cell transplantation

  • Morbidity Index

    at one year

  • Morbidity Index

    at two years

  • Survival without disease and chronic graft-versus-host disease

    at one year post allogeneic hematopoietic stem cell transplantation

  • Survival without disease and chronic graft-versus-host disease

    at two years post allogeneic hematopoietic stem cell transplantation

  • +22 more secondary outcomes

Interventions

Questionnaires on nutritional status, autonomy and quality of life

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 60 years who received an allogeneic hematopoietic stem cell transplantation HSCT

You may qualify if:

  • 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

You may not qualify if:

  • Patient opposed to the protocol
  • Vulnerable patients protected by curatorship or administrative supervision
  • Patients not covered by a social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CHU Amiens

Amiens, France

Location

CHU Angers

Angers, France

Location

CHU Besancon

Besançon, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Caen

Caen, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Grenoble

Grenoble, France

Location

CHRU Lille

Lille, France

Location

CHU Limoges

Limoges, France

Location

CHU Lyon

Lyon, France

Location

CHU Montpellier

Montpellier, France

Location

CHRU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

CHU Nice

Nice, France

Location

Hopital de la Pitié Salpetrière

Paris, France

Location

Hopital Necker

Paris, France

Location

Hopital Saint Louis

Paris, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Interventions

Geriatric Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 5, 2020

Study Start

July 3, 2020

Primary Completion

October 17, 2023

Study Completion

October 17, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Locations