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NCT04701229: SMD-RMB22
Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes
trial testing somatic cytogenetic and genetic characterization in Myelodysplastic Syndromes in 100 participants. Status unknown.
30 September 2022
Quick facts
| Lead sponsor | University Hospital, Brest |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 30 September 2020 |
| Primary completion | 30 September 2022 |
| Estimated completion | 30 September 2023 |
| Sites | 3 locations across France |
Drugs / interventions tested
- somatic cytogenetic and genetic characterization
Conditions studied
- Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
- Myelodysplastic Syndrome With Isolated Del(5Q) — all drugs for Myelodysplastic Syndrome With Isolated Del(5Q) →
- Myelodysplastic Syndrome With Del(5Q) — all drugs for Myelodysplastic Syndrome With Del(5Q) →
Sponsor
University Hospital, Brest
Who can join
18 and older, any sex, with Myelodysplastic Syndromes or Myelodysplastic Syndrome With Isolated Del(5Q). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Myelodysplastic syndromes (MDS) are malignant hematopathies of the elderly characterized by persistent cytopenias and the presence of deregulated clonal hematopoiesis. The risk of progression to acute myeloid leukemia (AML) is variable. Acquired cytogenetic abnormalities are found in less than 50% of de novo cases and up to 80% in secondary MDS. The deletion of the long arm of chromosome 5 (written del(5q)) is the most common abnormality in MDS (15%). Del(5q) MDS has a good prognosis, with a median survival of 6 years and a 15% risk of progression to AML. However, their life expectancy is shorter than the general population, and the quality of life of patients is diminished. These treatments are not that effective over a long period of time or not well tolerated, and the majority of patients die from causes related to their MDS, such as infections (38%), progression to AML (15%), or bleeding (13%). Two genes, RBM22 and SLU7, coding for proteins of the same complex involved in splicing pre-messenger RNA are carried on the long arm of chromosome 5. We investigate the pronostic impact and the predictive value of the double haploinsufficiency of the RBM22 and SLU7 genes in del(5q) myelodysplastic syndromes isolated or not compared to the single haploinsufficiency of RBM22 and normal karyotype myelodysplastic syndromes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04701229
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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 NCT04701229 (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 University Hospital, Brest
- Last refreshed: 8 January 2021
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/NCT04701229.
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