Danish Elder Lymphoma Patient Hematopoietic Investigation

NCT05245487 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-12-22

No results posted yet for this study

Summary

Every year approximately 300 Danish patients die from lymphoma. The median age at diagnosis is 70 years. Lymphoma can be efficiently treated with chemotherapy, and potentially cured. However, sufficient treatment is often hampered by toxicity, especially in elderly patients. It is also well known that the main risk factor for dying of lymphoma is age. New biologically targeted therapies with fewer side effects are becoming available for lymphoma treatment, however it is currently difficult to delineate which patients benefit from chemotherapy and which should be treated with novel expensive therapies.

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.

Conditions

  • Lymphoma
  • Chemotherapy-induced Neutropenia
  • Chemotherapy-Related Leukemia
  • Chemotherapeutic Toxicity

Interventions

DIAGNOSTIC_TEST

DNA repair gene mutation analysis

Prospective monitoring of patients with next-generation sequencing for blood mutations

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Gødstrup Hospital

    collaborator OTHER
  • Vejle Hospital

    collaborator OTHER
  • Sonderborg Hospital

    collaborator OTHER_GOV
  • Danish Cancer Society

    collaborator OTHER
  • Zealand University Hospital

    collaborator OTHER
  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Simon Husby, MD PhD · Rigshospitalet, Denmark

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2025-12-31
Completion
2035-01-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245487 on ClinicalTrials.gov