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

NCT ID: NCT02810262

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2019-12-31

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.

Detailed Description

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Conditions

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Bone Metastases Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bone metastases biopsy

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cyrille Confavreux, MD, PhD

Role: CONTACT

+33 4 72 11 74 79

Nadège Trehet-Mendel

Role: CONTACT

+33 4 72 11 74 46

Facility Contacts

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Cyrille Confavreux, MD, PhD

Role: primary

+33 4 72 11 74 79

Nadège Trehet-Mendel

Role: backup

+33 4 72 11 74 46

References

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Dirckx N, Tower RJ, Mercken EM, Vangoitsenhoven R, Moreau-Triby C, Breugelmans T, Nefyodova E, Cardoen R, Mathieu C, Van der Schueren B, Confavreux CB, Clemens TL, Maes C. Vhl deletion in osteoblasts boosts cellular glycolysis and improves global glucose metabolism. J Clin Invest. 2018 Mar 1;128(3):1087-1105. doi: 10.1172/JCI97794. Epub 2018 Feb 12.

Reference Type DERIVED
PMID: 29431735 (View on PubMed)

Other Identifiers

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D50772

Identifier Type: -

Identifier Source: org_study_id

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