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Chronic stress and Responsiveness to Immunotherapy for Metastasized Melanoma

Chronic stress and Responsiveness to Immunotherapy for Metastasized Melanoma - CRIMM-pilot study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55104
Enrollment
30
Registered
2019-10-31
Start date
2020-01-31
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

malignant melanoma skin cancer

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults (above 18 years) Diagnosed with metastasized melanoma Starting immunotherapy within the next two weeks. Treatment regimen: pembrolizumab 3 or 6-weekly, nivolumab 4-weekly, ipilimumab/nivolumab 3-weekly.

Exclusion criteria

Exclusion criteria: Age under 18 years Obvious intellectual impairment Insufficient knowledge of the Dutch language. Patients with no or very short hair

Design outcomes

Primary

MeasureTime frame
Main study parameter is whether chronic stress is related to response 3 and 6 months after the start of immunotherapy.

Secondary

MeasureTime frame
Demographic (age, gender, social relational variables) and medical variables (type, duration and doses of immunotherapy, immunotherapy related adverse events, use of immunosuppressive agents, LDH, pain, WHO-performance, location of metastases, oral contraceptive use) will be collected from medical records and by asking some additional questions at baseline.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)