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

• Conditions: Bone Metastases; Lung Cancer
• Interventions: Other: Bone metastases biopsy

• Registration Number: NCT02810262
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• adults over 18 years
• both gender
• covered by the French National Insurance
• first bone metastases of adenocarcinoma lung cancer (synchronous or metachrone)

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Exclusion Criteria

• adenocarcinoma previously treated by systemic oncologic treatment (chemotherapy, targeted therapy, immunotherapy)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
First bone metastasis of adenocarcinoma lung cancer	Bone metastases biopsy	Patients entering the group have a suspected first bone metastasis of adenocarcinoma lung cancer and should undergo bone biopsy to histologically prove the diagnosis.

Primary Outcome Measures

Name	Time	Method
serum DKK1	day 0	Biomarkers are assessed at baseline.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hôpital Edouard Herriot - Centre des Métastases Osseuses (CEMOS); 🇫🇷 Lyon, France