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NCT02164071: GAH
Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies
trial testing Geriatric Assessment of Health Status Scale administration in Myelodysplastic Syndromes in 363 participants. Completed in 4 July 2015.
3 December 2013
Quick facts
| Lead sponsor | Celgene |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 363 |
| Start date | 11 April 2012 |
| Primary completion | 3 December 2013 |
| Estimated completion | 4 July 2015 |
| Sites | 22 locations across Spain |
Drugs / interventions tested
- Geriatric Assessment of Health Status Scale administration
Conditions studied
- Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
- Leukemia Myeloid Acute — all drugs for Leukemia Myeloid Acute →
- Multiple Myeloma — all drugs for Multiple Myeloma →
- Leuklemia, Lymphocytic, Chronic — all drugs for Leuklemia, Lymphocytic, Chronic →
Sponsor
Celgene — full company profile →
Who can join
65 and older, any sex, with Myelodysplastic Syndromes or Leukemia Myeloid Acute. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02164071
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02164071 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Celgene
- Last refreshed: 18 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02164071.
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