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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03386916
Other study ID # 38RC17.218
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 12, 2017
Last updated December 28, 2017
Start date January 2010
Est. completion date September 2018

Study information

Verified date December 2017
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In case of primary lung cancer, bone metastases biopsy can be done in initial diagnosis or follow-up.

Nevertheless, any study focus on rentability and biopsy complications of lytic bone lesion for the context of lung cancer.

This study aims to demonstrate that CT scan guide percutaneous biopsy of lytic bone lesion help to anatomopathologic diagnosis and molecular biology with a low complication rate inasmuch a lung cancer is suspected.

This study is observational, retrospective, one center


Description:

Current progress in thoracic oncology require to be able to carry out analysis by molecular biology. So biopsies are done several times during cancer progression. But risk is high for a lung biopsy with enough sample, so a CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer can be an alternative.

In case of primary lung cancer, bone metastases biopsy can be done in initial diagnosis or follow-up. But this contribution in diagnostic (anatomopathologic an molecular biology) is poorly understood. It is demonstrated that to sample on lytic bone lesion have a failure rate lower than on calcified osseous lesion. Nevertheless, any study focus on rentability and biopsy complications of lytic bone lesion for the context of lung cancer.

this study aims to demonstrate that CT scan guide percutaneous biopsy of lytic bone lesion help to anatomopathologic diagnosis and molecular biology with a low complication rate inasmuch a lung cancer is suspected.

This study is observational, retrospective, descriptive, one-center Patient's records selection will be done by keyword search on the CHU Grenoble Alpes radiology software. Only records with bone biopsy register between January 2010 and June 2017 will be included.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date September 2018
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- CT scan guide percutaneous biopsy of lytic bone metastases

- register on CHU Grenoble Alpes radiology software between January 2010 and June 2017

- Patient who have a clinical context of lung cancer with bone metastases

Exclusion Criteria:

- Person deprived of liberty by judicial order

- Opposition expressed by patient

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

References & Publications (5)

Fraser-Hill MA, Renfrew DL. Percutaneous needle biopsy of musculoskeletal lesions. 1. Effective accuracy and diagnostic utility. AJR Am J Roentgenol. 1992 Apr;158(4):809-12. — View Citation

Jelinek JS, Murphey MD, Welker JA, Henshaw RM, Kransdorf MJ, Shmookler BM, Malawer MM. Diagnosis of primary bone tumors with image-guided percutaneous biopsy: experience with 110 tumors. Radiology. 2002 Jun;223(3):731-7. — View Citation

Leffler SG, Chew FS. CT-guided percutaneous biopsy of sclerotic bone lesions: diagnostic yield and accuracy. AJR Am J Roentgenol. 1999 May;172(5):1389-92. — View Citation

Vanderlaan PA, Yamaguchi N, Folch E, Boucher DH, Kent MS, Gangadharan SP, Majid A, Goldstein MA, Huberman MS, Kocher ON, Costa DB. Success and failure rates of tumor genotyping techniques in routine pathological samples with non-small-cell lung cancer. Lung Cancer. 2014 Apr;84(1):39-44. doi: 10.1016/j.lungcan.2014.01.013. Epub 2014 Jan 28. — View Citation

Vieillard MH, Boutry N, Chastanet P, Duquesnoy B, Cotten A, Cortet B. Contribution of percutaneous biopsy to the definite diagnosis in patients with suspected bone tumor. Joint Bone Spine. 2005 Jan;72(1):53-60. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rentability of biopsy of lytic bone lesion in anatomopathologic analysis Rentability of biopsy of lytic bone lesion = 100x (number of sample wich analysed by anatomopathologic /total number of biopsy of lytic bone lesion done) Analysis between january 2018-september 2018
Secondary Rentability of biopsy of lytic bone lesion in molecular biology analysis inas much non small cell epidermoid lung cancer is diagnosed Rentability of biopsy of lytic bone lesion in molecular biology analysis inas much non small cell epidermoid lung cancer is diagnosed
- =100x (number of sample wich analysed by molecular biology /total number of biopsy of lytic bone lesion sent to molecular biology analysis)
Analysis between january 2018-september 2018
Secondary Cell quality in sample of biopsy of lytic bone lesion in molecular biology analysis inas much non small cell epidermoid lung cancer is diagnosed Cell quality in sample of biopsy of lytic bone lesion in molecular biology analysis inas much non small cell epidermoid lung cancer is diagnosed
average percentage of tumour cells in samples
Analysis between january 2018-september 2018
Secondary Complication rate linked to gesture of biopsy of lytic bone lesion Complication rate linked to gesture of biopsy of lytic bone lesion and descriptive analysis Analysis between january 2018-september 2018
Secondary Impact assessement of biopsy of lytic bone lesion on patient care Modification of management of lung cancer between before biopsy and after biopsy results Analysis between january 2018-september 2018