Trial document




drksid header

  DRKS00003601

Trial Description

start of 1:1-Block title

Title

Prognostic value and development of psycho-social factors and functional aspects in elderly patients with higher risk MDS and AMl. A multi-center observational study.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Joint decision-making resulting in the individually best treatment option (especially regarding treatment intensity) is one of the most difficult tasks in the care of elderly leukemia patients. Objective patient-specific parameters that can facilitate this process have not been sufficiently investigated. It is essential to obtain solid knowledge on subjective quality of life, functional reserves and psychological distress of the affected patients. Our aim is to validate previous data on a Comprehensive Geriatric and Quality of Life Assessment in 500 patients with higher risk MDS and AML in a prospective multic-center observational study.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Prospective prognostic factor study for elderly leukemia patients based on results of a comprehensive geriatric and quality of life assessment.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003601
  •   2012/04/13
  •   [---]*
  •   yes
  •   Approved
  •   122/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C92.0 -  Acute myeloid leukaemia
  •   D46 -  Myelodysplastic syndromes
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with MDS/AML will be asked to undergo a geriatric and quality of life assessment prior to treatment initiation and every three months thereafter for one year.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Overall survival within a 2.5 year observation period. Components of a comprehensive geriatric assessment will be evaluated for their prognostic value.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Independence (Barthel Index), Quality of Life (EORTC QLQ C 30), psychologigal distress (HADS) prior to treatment initiation, and every 3 months for 1 year.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/04/16
  •   500
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Higher risk MDS/AML, age >/= 60 years, written informed consent, anticipated compliance and geographic proximity for follow-up assessments

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

other malignant diseases not in remission, impaired mental status with inability to fill out questionnaires and to obey simple demands. Trial participation for medical therapy is NOT an exclusion criterion

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Universitätsklinik Freiburg
    • Mr.  Prof. Dr. med.   Michael  Luebert 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0761 270 32790
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinik Freiburg, Med. Klinik Abteilung Hämatologie/ Onkologie
    • Mr.  Prof. Dr. med.  Michael  Luebbert 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg, Abt. Med. 1 Hämatologie / Onkologie
    • Mr.  Prof. Dr. med.  Michael  Luebbert 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • José Carreras Leukämie-Stiftung
    • Elisabethstraße 23
    • 80796  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   089 / 272 904-0
    •   089 / 272 904-44
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.