Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)

Study Overview
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Brief Summary
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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.

Official Title
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Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)

Conditions
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Bone Metastases, Lung Cancer

Intervention / Treatment
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* Other: Bone metastases biopsy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First bone metastasis of adenocarcinoma lung cancer<br>Patients entering the group have a suspected first bone metastasis of adenocarcinoma lung cancer and should undergo bone biopsy to histologically prove the diagnosis. | Other: Bone metastases biopsy<br>* The vast majority of bone biopsy are performed under CT-scan. In some rare cases, the histology will be performed during surgery (either biopsy of the bone metastasis or surgical piece when treating a fracture).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum DKK1 | Biomarkers are assessed at baseline. | day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum HbA1C | Biomarkers are assessed at baseline | day 0 | 
| urinary CTX | Biomarkers are assessed at baseline | day 0 | 
| hip bone mass (g/cm²) | Whole body densitometry is performed at baseline | day 0 | 
| mutational profile of the bone metastases | Molecular characterization of the bone metastases by PCR (EGFR, KRAS, BRAF) and FISH (ALK) | day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Bone metastases, EGFR, KRAS, Bone biomarkers, Metabolic parameters