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CT Scan Guide Percutaneous Biopsy of Lytic Bone Metastases of Lung Cancer : Contribution in Pathology Diagnosis and Molecular Biology (stasfa)

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ClinicalTrials.gov Identifier: NCT03386916
Recruitment Status : Active, not recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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


Condition or disease Intervention/treatment
Image-Guided Biopsy - Carcinoma, Bronchogenic / Diagnosis- Outpatients Procedure: CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer

Detailed 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.


Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: CT Scan Guide Percutaneous Biopsy of Lytic Bone Metastases of Lung Cancer : Pathology Diagnosis and Molecular Biology
Actual Study Start Date : January 2010
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patient with a CT scan guide percutaneous biopsy of lytic bone
Patient with a CT scan guide percutaneous biopsy of lytic bone metastases register on CHU Grenoble Alpes radiology software between January 2010 and June 2017
Procedure: CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer



Primary Outcome Measures :
  1. Rentability of biopsy of lytic bone lesion in anatomopathologic analysis [ Time Frame: Analysis between january 2018-september 2018 ]
    Rentability of biopsy of lytic bone lesion = 100x (number of sample wich analysed by anatomopathologic /total number of biopsy of lytic bone lesion done)


Secondary Outcome Measures :
  1. Rentability of biopsy of lytic bone lesion in molecular biology analysis inas much non small cell epidermoid lung cancer is diagnosed [ Time Frame: Analysis between january 2018-september 2018 ]

    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)


  2. Cell quality in sample of biopsy of lytic bone lesion in molecular biology analysis inas much non small cell epidermoid lung cancer is diagnosed [ Time Frame: Analysis between january 2018-september 2018 ]

    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

  3. Complication rate linked to gesture of biopsy of lytic bone lesion [ Time Frame: Analysis between january 2018-september 2018 ]
    Complication rate linked to gesture of biopsy of lytic bone lesion and descriptive analysis

  4. Impact assessement of biopsy of lytic bone lesion on patient care [ Time Frame: Analysis between january 2018-september 2018 ]
    Modification of management of lung cancer between before biopsy and after biopsy results



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386916


Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Study Director: Gilbert FERRETTI UniversityHospital Grenoble

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03386916     History of Changes
Other Study ID Numbers: 38RC17.218
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
Technology, Radiologic - Radiography, Interventional - Image-Guided Biopsy - Early Detection of Cancer - Carcinoma, Bronchogenic / diagnosis - Outpatients

Additional relevant MeSH terms:
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases