Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies (GAH)

November 14, 2019 updated by: Celgene

The elderly comprise the most prevalent population in oncology practice. The available evidence suggests that old patients are undertreated patients, mainly because of their advanced age, regardless of whether they are highly functional patients, they do not present co morbidities and could benefit from oncology therapies.

Treatment planning must consider several health indices that are useful when it comes to detecting geriatric problems that could affect the patient's treatment experience. The complete comprehensive geriatric evaluation stands out as cornerstone among other validated tools that do not work as isolated instruments; however, its length and complexity may hinder its routine use in clinical practice for decision making.

The purpose of this study is to validate a comprehensive health status assessment scale in elderly patients (≥65 years) with hematological malignancies that, while integrating the essential dimensions of geriatric assessment and, with the same precision as the currently available valid tools, is shorter and easier to apply, so it can be incorporated into the daily practice and that aids in clinical decision making objectively.

If so, this information would help identify patients that could benefit from a specific oncology treatment, thus contributing to developing a targeted intervention plan and to optimizing the cancer results in this patient population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
363

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • La Coruna, Spain, 15006
        • C.H. Universitario A Coruña
      • Lerida, Spain, 25198
        • Arnau de Vilanova
      • Madrid, Spain, 28007
        • Hospital U. Gregorio Marañón
      • Madrid, Spain, 28031
        • Hospital Infanta Leonor
      • Segovia, Spain, 40002
        • Hospital de Segovia
      • Sevilla, Spain, 41013
        • Hospital Virgen Del Rocio
      • Valencia, Spain, 46026
        • Hospital La Fe
    • Alava
      • Vitoria, Alava, Spain, 01009
        • Hospital Txagorritxu
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Universitario Central de Asturias
    • Barcelona
      • Espluges De Llobregat, Barcelona, Spain, 08950
        • Hospital Sant Joan de Déu
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Duran i Reynals
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20080
        • Hospital de Donostia
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital U. Puerta de Hierro
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • C.H. Navarra
    • Tenerife
      • San Cristobal de la Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Hospital Ntra. Sra. La Candelaria
    • Valencia
      • Alzira, Valencia, Spain, 46600
        • Hospital La Ribera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible patients, even being naïve to treatment, are eligible to receive treatment at any time as per clinical practice. Patients ≥ 65 years old, newly diagnosed, naïve to treatment, belonging to one of the 3 following groups. 1.- Patients with Myelodysplastic Syndromes (any risk according to) or Acute myeloid leukemia; 2.- Patients with Multiple Myeloma, either symptomatic or asymptomatic; or 3.- Patients with Chronic lymphocytic leukemia (including stadium A).

Description

Inclusion Criteria:

Patients ≥ 65 years old. Treatment-naïve patients

Newly diagnosed patients who belong to one of the 3 following groups:

Patients with MDS (any risk grade as per IPSS) or AML Patients with multiple myeloma (symptomatic or not) or Patients with chronic lymphocytic leukemia (including A status) Patients who have granted their informed consent.

Exclusion Criteria:

Not fulfilling selection criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Multiple Myeloma (MM)
Patients with Myltiple Myeloma, symptomatic or asymptomatic
Other: Geriatric Assessment of Health Status Scale administration
Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days
Other Names:
  • Geriatric Assessment of Health Status Scale
Myelodysplastic Syndromes or Acute Myeloid Leukemia
Patients with Myelodysplastic Syndromes (MDS), any International Prognostic Scoring System (IPSS) risk, or Acute Myeloid Leukemia (AML)
Other: Geriatric Assessment of Health Status Scale administration
Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days
Other Names:
  • Geriatric Assessment of Health Status Scale
Chronic Lymphocytic Leukemia (CLL)
Patients with Chronic Lymphocytic Leukemia
Other: Geriatric Assessment of Health Status Scale administration
Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days
Other Names:
  • Geriatric Assessment of Health Status Scale

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geriatric Health Assessment (GHA) Questionnaire
Time Frame: Approximately 2.5 years
A composite variable comprised of all the dimensions that make up the GHA questionnaire will be obtained on stable patients as a result of the implementation of a questionnaire by two independent evaluators: one investigator and one duly trained health professional.
Approximately 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jose Luis Garcia, PhD, Celgene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEL-GAH-2011-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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