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

April 1, 2019 updated by: Hospices Civils de Lyon

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Hospices Civils de Lyon - Hôpital Edouard Herriot - Centre des Métastases Osseuses (CEMOS)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
First bone metastasis of adenocarcinoma lung cancer
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
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D50772

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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