Image-Guided Biopsy - Carcinoma, Bronchogenic / Diagnosis- OutpatientsstasfaNCT03386916
CT Scan Guide Percutaneous Biopsy of Lytic Bone Metastases of Lung Cancer : Contribution in Pathology Diagnosis and Molecular Biology
An observational study of Image-Guided Biopsy - Carcinoma, Bronchogenic / Diagnosis- Outpatients, run by University Hospital, Grenoble.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Image-Guided Biopsy - Carcinoma, Bronchogenic / Diagnosis- Outpatients
- What is being tested?
- CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer
Who may be able to join
- 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
Who cannot join
- Person deprived of liberty by judicial order
- Opposition expressed by patient
About this study
Official title: CT Scan Guide Percutaneous Biopsy of Lytic Bone Metastases of Lung Cancer : Pathology Diagnosis and Molecular Biology
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.
- Being tested
- CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer
- Keywords
- Technology, Radiologic - Radiography, Interventional - Image-Guided Biopsy - Early Detection of Cancer - Carcinoma, Bronchogenic / diagnosis - Outpatients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan guide percutaneous biopsy of lytic bone metastases of lung cancerProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Analysis between january 2018-september 2018
Secondary outcomes (4)
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)
Measured: 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
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
Measured: Analysis between january 2018-september 2018
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
Measured: Analysis between january 2018-september 2018
Impact assessement of biopsy of lytic bone lesion on patient care
Modification of management of lung cancer between before biopsy and after biopsy results
Measured: Analysis between january 2018-september 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study startJan 2010
- Primary completionJun 2017
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Image-Guided Biopsy - Carcinoma, Bronchogenic / Diagnosis- OutpatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert FERRETTI, Study director, UniversityHospital Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386916
- Sponsor's protocol ID
- 38RC17.218
- Acronym
- stasfa
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 12034942Fraser-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 1546597Leffler 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 10227522Vieillard 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 15681249Vanderlaan 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Scan Guide Percutaneous Biopsy of Lytic Bone Metastases of Lung Cancer : Pathology Diagnosis and Molecular Biology
- ClinicalTrials.gov ID
- NCT03386916
- Acronym / sponsor ID
- stasfa / 38RC17.218
- Keywords
- Technology, Radiologic - Radiography, Interventional - Image-Guided Biopsy - Early Detection of Cancer - Carcinoma, Bronchogenic / diagnosis - Outpatients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with a CT scan guide percutaneous biopsy of lytic bone | – | Procedure: CT scan guide percutaneous biopsy of lytic bone metastases of lung cancerPatient with a CT scan guide percutaneous biopsy of lytic bone metastases register on CHU Grenoble Alpes radiology software between January 2010 and June 2017 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Person deprived of liberty by judicial order
- Opposition expressed by patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer | Procedure or surgery | Patient with a CT scan guide percutaneous biopsy of lytic bone |
Primary outcome
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)
4 secondary outcomes
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
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
Complication rate linked to gesture of biopsy of lytic bone lesion
Time frame: Analysis between january 2018-september 2018
Impact assessement of biopsy of lytic bone lesion on patient care
Time frame: Analysis between january 2018-september 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Background: PubMed 12034942Jelinek 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.
- Background: PubMed 1546597Fraser-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.
- Background: PubMed 10227522Leffler 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.
- Background: PubMed 15681249Vieillard 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.
- Background: PubMed 24513263Vanderlaan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert FERRETTI study director
UniversityHospital Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Image-Guided Biopsy - Carcinoma, Bronchogenic / Diagnosis- Outpatients, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rentability of biopsy of lytic bone lesion in anatomopathologic analysis (time frame: Analysis between january 2018-september 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03386916, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.