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OpenTrials
Completed

NCT Number: NCT02810262

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

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.

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Key information

Conditions

Bone Metastases Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon - Hôpital Edouard Herriot - Centre des Métastases Osseuses (CEMOS)

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bone metastases biopsy

Other

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).

Primary outcomes

  1. serum DKK1

    Time frame: day 0

    Biomarkers are assessed at baseline.

Secondary outcomes

  1. serum HbA1C

    Time frame: day 0

    Biomarkers are assessed at baseline

  2. urinary CTX

    Time frame: day 0

    Biomarkers are assessed at baseline

  3. hip bone mass (g/cm²)

    Time frame: day 0

    Whole body densitometry is performed at baseline

  4. mutational profile of the bone metastases

    Time frame: day 0

    Molecular characterization of the bone metastases by PCR (EGFR, KRAS, BRAF) and FISH (ALK)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: POUMOS

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2016
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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