RecruitingNCT05326919

The Patient Cohort of the National Center for Precision Medicine in Leukemia


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

3,000 participants

Start Date

Mar 28, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

If for years the treatment strategy of leukemia and related disorders (LRDs, including acute leukemias and predisposition syndromes) has been based solely on whether the patient could receive or not intensive chemotherapy and transplantation, the advent of new targeted or less targeted drugs has led to the development of a growing number of new therapeutic approaches, very often offered to specific patient/disease subsets, justifying the generic term of 'precision medicine'. As an international leukemia center of excellence, THEMA, the French National Center for Precision Medicine in Leukemia (selected as IHUB-2 by the French National Agency for Research), is a care, research, transfer and education initiative located at the Saint-Louis Research Institute (IRSL) in Paris and devoted to precision medicine in leukemia in a real-life environment. The present non-interventional study (eTHEMA) is a pillar of the whole THEMA project. As a prerequisite for precision medicine, this program focuses on individual data collection, aiming to collect high-quality data not only in patients treated into prospective clinical trials, but in every THEMA patient with a special interest in outpatients' care and research. The primary objective of this non-interventional study is to describe the baseline characteristics planned treatments and outcomes of patients newly diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN)-related myelofibrosis, when managed and treated according to standard diagnosis and care practices.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is building a national registry of patients newly diagnosed with leukemia or related blood cancers to advance precision medicine — finding the right treatment for each individual patient. **You may be eligible if...** - You have been newly diagnosed with leukemia (AML, ALL), high-risk myelodysplastic syndrome (MDS), or myelofibrosis - You have not received prior treatment for this blood cancer - You have health insurance coverage **You may NOT be eligible if...** - You have already received significant treatment for your blood cancer (some exceptions apply for certain limited prior therapies) - You are under legal guardianship or curatorship - You object to your data being included in the research registry Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBiobanking

For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored.


Locations(3)

Hôpital Avicenne

Bobigny, France

Hopital Robert Debré

Paris, France

Hôpital Saint Louis

Paris, France

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NCT05326919


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