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Study of menopause in ex-patients with Hodgkin lymphoma: Influence on long-term adverse effects

Study of menopause in ex-patients with Hodgkin lymphoma: Influence on long-term adverse effects - SOPHIA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38514
Enrollment
300
Registered
2013-10-23
Start date
2013-09-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporose early menopause Premature menopause

Interventions

None listed

Sponsors

Nederlands Kanker Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female 8-year Hodgkin lymphoma survivors - Treated in the Netherlands between 1965-2005 at ages 15-39 years in AVL, VUmc and LUMC - Alive at study entry

Exclusion criteria

Exclusion criteria: - Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol - Insufficient understanding of the Dutch language - Aged 75 years or older at study entry - Currently under treatment for second malignancy

Design outcomes

Primary

MeasureTime frame
The outcomes of bone mineral density, cardiovascular status, neurocognitive functioning and quality of life will be compared between HL survivors who developed a premature menopause with those who did not.

Secondary

MeasureTime frame
The effect of hormone therapy on BMD, cardiovascular status and neurocognitive functioning. To difference in long-term effects of premature menopause on BMD, cardiovascular status and neurocognitive functioning between a CT- and RT-induced premature menopause.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)