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Trial record 30 of 83 for:    PEELING SKIN SYNDROME

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

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ClinicalTrials.gov Identifier: NCT02164071
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation

Brief Summary:

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.


Condition or disease Intervention/treatment
Myelodysplastic Syndromes Leukemia Myeloid Acute Multiple Myeloma Leuklemia, Lymphocytic, Chronic Other: Geriatric Assessment of Health Status Scale administration

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Study Type : Observational
Actual Enrollment : 363 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies
Study Start Date : April 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : July 2015


Group/Cohort Intervention/treatment
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 Name: 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 Name: 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 Name: Geriatric Assessment of Health Status Scale




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164071


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

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Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT02164071     History of Changes
Other Study ID Numbers: CEL-GAH-2011-01
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by Celgene Corporation:
Haematological malignancy
Elderly
Health Status
Scale validation

Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Multiple Myeloma
Neoplasms
Preleukemia
Leukemia, Myeloid
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Leukemia