NCT02810262

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 2, 2019

Status Verified

April 1, 2019

Enrollment Period

8.5 years

First QC Date

June 20, 2016

Last Update Submit

April 1, 2019

Conditions

Bone MetastasesLung Cancer

Keywords

Lung cancerBone metastasesEGFRKRASBone biomarkersMetabolic parameters

Outcome Measures

Primary Outcomes (1)

  • serum DKK1

    Biomarkers are assessed at baseline.

    day 0

Secondary Outcomes (4)

  • serum HbA1C

    day 0

  • urinary CTX

    day 0

  • hip bone mass (g/cm²)

    day 0

  • mutational profile of the bone metastases

    day 0

Study Arms (1)

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

Interventions

Bone metastases biopsyOTHER

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).

First bone metastasis of adenocarcinoma lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lyon, 69003, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29431735DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine Serum and plasma Bone biopsy Whole blood

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Cyrille Confavreux, MD, PhD

CONTACT

+33 4 72 11 74 79cyrille.confavreux@chu-lyon.fr

Nadège Trehet-Mendel

CONTACT

+33 4 72 11 74 46centre.prevention@wanadoo.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

June 1, 2011

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 2, 2019

Record last verified: 2019-04

Locations

FR(1)