Danish Elder Lymphoma Patient Hematopoietic Investigation
NCT ID: NCT05245487
Last Updated: 2023-12-22
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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RECRUITING
300 participants
OBSERVATIONAL
2022-01-01
2035-01-01
Brief Summary
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Recently, it has been discovered that chemotherapy can provoke growth of patient blood cells with DNA mutations. This leads to increased rates of treatment side effects and excess mortality. These defects have so far only been examined in younger patients below 70 years of age, where they are found in roughly 10% of patients. It remains unknown to what extent elderly individuals are affected, but the investigators hypothesize that the proportion and negative effects are much larger.
Therefore, the investigators propose to investigate the frequency and evolution of these DNA mutations during chemotherapy in a prospective study of patients, who are either above 60 years of age and previously treated with chemotherapy for lymphoma in a nation-wide collaboration.
By using blood samples, advanced genetic analyses and patient-reported questionnaires, the investigators will study
* The prevalence of these mutations and their consequences for patient wellbeing, treatment side effects (such as anemia, infections etc.) and mortality
* The kinetics of these mutations during and after treatment, and explore possible evolutionary patterns of the inferred damages The investigators expect to include 300 patients in the study and that the first results will be ready in a timeframe of 4 years. The investigators hope to obtain new insights in the risk factors for physiological and mental health in lymphoma patients and thereby pave the way for improvements in wellbeing and survival of this underserved population.
Detailed Description
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Inclusion criteria:
* Diagnosis of B-cell Non-Hodgkin lymphoma
* In need of systemic treatment with second (2.) or higher line of active therapy for lymphoma
* 60 years of age or older (no age maximum)
Exclusion criteria:
* Unable to give written consent
* Non-Danish citizens
Patients will be included by their treating physcian at their local department. All analyses are centralized. Blood samples for research puporses will be taken before, midway (tipically before 3rd / 4th series depending on regimen) and 4-8 weeks after treatment. Also QOL questionaires will be sent electronically to the patients. The results of the tests performed will blinded to the patient and the treating physician.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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DNA repair gene mutation analysis
Prospective monitoring of patients with next-generation sequencing for blood mutations
Eligibility Criteria
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Inclusion Criteria
* In need of systemic treatment with second (2.) or higher line of active therapy for lymphoma
* 60 years of age or older (no age maximum)
Exclusion Criteria
* Non-Danish citizens
60 Years
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Gødstrup Hospital
OTHER
Vejle Hospital
OTHER
Sonderborg Hospital
OTHER_GOV
Danish Cancer Society
OTHER
Zealand University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Simon Husby, MD, PhD
MD, PhD
Principal Investigators
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Simon Husby, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Dept. of Hematology, Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Kirsten Grønbæk, Prof.
Role: CONTACT
Facility Contacts
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Simon Husby, MD PhD
Role: primary
Other Identifiers
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DELPHI
Identifier Type: -
Identifier Source: org_study_id