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RecruitingNCT07740239COSMOS-IUpdated Jul 31, 2026

A COhort Study on Factors Leading to Vulnerability in Adult Patients With Serious Medical cOnditionS: the COSMOS-I Trial

An observational study in Pelvic Fracture, Prostate Cancer and Lung Cancer, sponsored by Tampere University Hospital. Recruiting at 1 site in Finland. Open to male participants. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Tampere University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,050
Sex
Male
01

Study summary

The objective of this prospective multicentre study that recruits altogether 1500 older patients from the university hospitals of Tampere, Kuopio, and Oulu is to explore the clinical significance and detection of causes of generalized vulnerability. The objectives are:

O1 - Establish the prevalence of causes of generalized vulnerability among patients diagnosed with severe yet non-malignant diseases and local/locally advanced and advanced cancers, O2 - Study how causes of generalized vulnerability affect the time between the diagnosis and the adoption of a fully palliative treatment line, overall survival, and patient-reported quality of life in older adults severe diseases, and O3 - Evaluate how screening tools commonly used in patients without cancer perform in screening for causes of vulnerability in older adults with cancer

02

Conditions studied

  • Pelvic Fracture
  • Prostate Cancer
  • Lung Cancer
  • Brain Metastasis
  • Chronic Subdural Hematoma
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

  • Patients with local, locally advanced and metastatic prostate cancer (n=300)
  • Patients with locally advanced and metastatic lung cancer (n=300)
  • Patients with brain metastasis (n=300)
  • Patients with chronic subdural hematoma (n=300)
  • Patients receiving high-dose chemotherapy and stem cell transplantion

Inclusion criteria

  • Suspected or diagnosed disease
  • ≥60 years old patients, except for patients receiving high-dose chemotherapy and stem cell transplantion who need to be ≥18 years old
  • Cross-sectional imaging maximum 45 days prior to consenting or before the next treatment line
  • Patients with cancer (other than patients with prostate cancer treated with hormonal treatment before radiation treatment): study procedures (excluding image analyses) must have been carried out maximum 1 month prior to the start of a new treatment line
  • Patients with prostate cancers receiving hormonal treatment before radiation treatment): study procedures (excluding image analyses) must be carried out maximum 3 months after the start of hormonal treatment
  • Patients with other conditions: study procedures (excluding image analyses) must have been carried out maximum 4 days after the start of the hospitalization

Exclusion criteria

Exclusion Criteria:

  • Not willing or unable to give written consent
  • Patient not deemed suitable for the study by the researcher approaching the patient
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,050 participants (estimated)
Patient registry
No

Groups and cohorts

  • Prostate Cancer

    Other: Test set to determine vulnerability

  • Lung Cancer

    Other: Test set to determine vulnerability

  • Pelvic Fracture

    Other: Test set to determine vulnerability

  • Chronic Subdural Hematoma

    Other: Test set to determine vulnerability

  • Brain Metastasis

    Other: Test set to determine vulnerability

  • High-dose Chemotherapy and Stem Cell Transplant

    Other: Test set to determine vulnerability

Interventions

  • OtherTest set to determine vulnerability

    This is a prospective observational study.

05

What researchers measure

Primary outcomes

  1. Detected cause of vulnerability

    Time frame: Around the time of study procedure

06

Study locations

1 of 1 sites recruiting
  • Tampere University Hospital
    Tampere, Finland
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07740239
Lead sponsor
Tampere University Hospital
Responsible party
Otso Arponen (Adjunct professor, MD, Tampere University Hospital) — Principal investigator
First posted
Jul 31, 2026
Start date
Nov 13, 2024
Primary completion
Dec 30, 2030 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Jul 31, 2026

Study contacts

Otso Arponen, Adjunct professor, MD
Contact
otso.arponen@tuni.fi
504106170 ext. +358

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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