Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- serum DKK1
Study Overview
Brief Summary
Mortality due to non small cell lung cancers is the first cause of cancer death in men around the world. Lung adenocarcinoma regularly induces bone metastases responsible for high morbidity and impaired life quality. Overall survival of these patients is poor. Thus the investigators aimed to identify if some bone and metabolic parameters were associated with overall survival.
Patients and Methods POUMOS is a prospective cohort of patients suffering from adenocarcinoma lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with molecular status characterization of the tumor for EGFR, KRAS, BRAF and ALK. Bone metastasis localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole body composition is obtained by DEXA scan (Hologic®). The investigators assessed also fasting blood levels of bone and metabolic biomarkers.
Survival analyses will be performed using a proportional hazard regression model.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adults over 18 years
- •both gender
- •covered by the French National Insurance
- •first bone metastases of adenocarcinoma lung cancer (synchronous or metachrone)
Exclusion Criteria
- •- adenocarcinoma previously treated by systemic oncologic treatment (chemotherapy, targeted therapy, immunotherapy)
Outcomes
Primary Outcomes
serum DKK1
Time Frame: day 0
Biomarkers are assessed at baseline.
Secondary Outcomes
- urinary CTX(day 0)
- serum HbA1C(day 0)
- mutational profile of the bone metastases(day 0)
- hip bone mass (g/cm²)(day 0)