CClinicalTrials.gg
Status unknownNCT03386916stasfaUpdated Dec 29, 2017

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

An observational study in Image-Guided Biopsy - Carcinoma, Bronchogenic / Diagnosis- Outpatients, sponsored by University Hospital, Grenoble. Status unknown. Per ClinicalTrials.gov, last updated 2017-12-29.

Sponsored by University Hospital, Grenoble · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
80
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Image-Guided Biopsy - Carcinoma, Bronchogenic / Diagnosis- Outpatients

Keywords

  • Technology, Radiologic - Radiography, Interventional - Image-Guided Biopsy - Early Detection of Cancer - Carcinoma, Bronchogenic / diagnosis - Outpatients
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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

Exclusion Criteria:

  • Person deprived of liberty by judicial order
  • Opposition expressed by patient
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureCT scan guide percutaneous biopsy of lytic bone metastases of lung cancer
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What researchers measure

Primary outcomes

  1. 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)

    Time frame: Analysis between january 2018-september 2018

Secondary outcomes

  1. 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)

    Time frame: Analysis between january 2018-september 2018

  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

    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

    Time frame: Analysis between january 2018-september 2018

  3. 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

    Time frame: Analysis between january 2018-september 2018

  4. Impact assessement of biopsy of lytic bone lesion on patient care

    Modification of management of lung cancer between before biopsy and after biopsy results

    Time frame: Analysis between january 2018-september 2018

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. doi: 10.1148/radiol.2233011050. PubMed 12034942 ↗
  • 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. doi: 10.2214/ajr.158.4.1546597. PubMed 1546597 ↗
  • 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. doi: 10.2214/ajr.172.5.10227522. PubMed 10227522 ↗
  • 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. doi: 10.1016/j.jbspin.2004.03.008. PubMed 15681249 ↗
  • 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. PubMed 24513263 ↗
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Registry details

Key details

Study ID
NCT03386916
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Dec 29, 2017
Start date
Jan 2010
Primary completion
Jun 2017
Completion
Sep 2018 (estimated)
Last update
Dec 29, 2017

Study contacts

Gilbert FERRETTI
study director · UniversityHospital Grenoble

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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