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

Lung Cancer Clinical Trial

— POUMOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02810262
• Other study ID #: D50772
• Status: Recruiting
• Start date: June 2011
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Hospices Civils de Lyon
• Contact: Cyrille Confavreux, MD, PhD
• Phone: +33 4 72 11 74 79
• Email: cyrille.confavreux[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Lung Cancer
• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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).

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Edouard Herriot - Centre des Métastases Osseuses (CEMOS)	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum DKK1	Biomarkers are assessed at baseline.	day 0
Secondary	serum HbA1C	Biomarkers are assessed at baseline	day 0
Secondary	urinary CTX	Biomarkers are assessed at baseline	day 0
Secondary	hip bone mass (g/cm²)	Whole body densitometry is performed at baseline	day 0
Secondary	mutational profile of the bone metastases	Molecular characterization of the bone metastases by PCR (EGFR, KRAS, BRAF) and FISH (ALK)	day 0