Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
104 participants
OBSERVATIONAL
2018-03-31
2025-04-30
Brief Summary
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Detailed Description
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Minimal residual disease (MRD-negative) is assessed in the clinic by 8-color flow cytometry giving the sensitivity level of MRD detection 10-5; MRD is measured in real clinical practice at this clinical center according to National recommendations in diagnostics and treatment of lymphoproliferative disorders.
To achieve study objectives medical patients' charts will be analyzed retrospectively. In the frame of this program 104 patients' charts treated in defined clinical site, are planned to be analyzed. This number of patients corresponds to the patient flow with this pathology at a defined clinical site for 1 years.
Data collection is considered to be retrospective as data will be transferred to e-CRF from patient medical charts. During this study no further specific extra procedures for data gathering is expected.
But since patients included in the study will be at the center of ongoing therapy, the study was called a prospective.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group Scale (ECOG) 0-2.
4. Total Chronic Illness Resources Survey scale (CIRS) score \>6 or creatinine clearance \<70 ml/min or both for patients ≥ 18 years old or all CLL pts ≥ 75 years old
5. Any cardiac pathology/ diabetes mellitus/ kidney pathology/ cytopenia (Hb \<100 g/l, Platelets \< 100 x 109/l)
6. Life expectancy more than 6 months according to the physician's opinion.
7. Signed informed consent that allow personal data and data that refer to patient confidentiality processing
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Healthy Future
OTHER
Responsible Party
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Principal Investigators
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Eugeny A Nikitin, MD
Role: PRINCIPAL_INVESTIGATOR
"The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department"
Locations
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The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department".
Moscow, , Russia
The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Eugeny A Nikitin, MD
Role: primary
References
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Под ред. А.Д. Каприна, В.В. Старинского, Г.В. Петровой, "Злокачественные новообразования в России в 2015 году (заболеваемость и смертность)" - М.: МНИОИ им. П.А. Герцена - филиал ФГБУ "НМИРЦ" Минздрава России - 2017. - ил. - 250 с. ISBN 978-5-85502-227-8.
Российские клинические рекомендации по диагностике и лечению лимфопролиферативных заболеваний. Под руководством профессора И.В. Поддубной, профессора В.Г. Савченко. М., 2016. - 412 с.
Kwok M, Rawstron AC, Varghese A, Evans PA, O'Connor SJ, Doughty C, Newton DJ, Moreton P, Hillmen P. Minimal residual disease is an independent predictor for 10-year survival in CLL. Blood. 2016 Dec 15;128(24):2770-2773. doi: 10.1182/blood-2016-05-714162. Epub 2016 Oct 3.
Other Identifiers
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ML40194
Identifier Type: -
Identifier Source: org_study_id
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