Lung CancerMétaux/PoumonsNCT01949181
Blood, Hair and Lung Concentrations of Metals and Metalloids in Patients With Lung Cancer or Chronic Obstructive Pulmonary Disease
A study testing Lung surgery in people with Lung Cancer and Chronic Obstructive Pulmonary Disease, run by Hopital Foch at 2 sites in France.
Trial summary
Prospective research to study the relationship between concentrations of metals/metalloids in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Chronic Obstructive Pulmonary Disease, Emphysema
- What is being tested?
- Lung surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 2 sitesFrance
- Study dates
- Aug 2011to Mar 2014
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of 18 to 75 years of age.
- Patients admitted for lung resection (either cancerous or non-cancerous) or lung transplant
Who cannot join
- Patients with mental or physical conditions that prevent them giving their agreement for the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Poitiers, Chirurgie Cardiaque et Thoracique
Poitiers, 86000
Hopital Foch
Suresnes, Île-de-France Region, 92150
About this study
Official title: Relationship Between Blood, Hair and Lung Metals/Metalloids Concentration (Cadmium, Iron, Copper, Nickel, Chrome, Arsenic, Vanadium, Beryllium, and Zinc) and Lung Cancer or Chronic Obstructive Pulmonary Disease.
Prospective research to study the relationship between concentrations of metals/metalloids in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive pulmonary disease.
- Being tested
- Lung surgery
- Keywords
- Metals, Metalloids, Blood, Hair, Lung, Lung cancer, Chronic obstructive pulmonary disease
- Medical subject headings
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary cancer | Experimental | Not described Receives: Procedure: Lung surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metals/metalloids concentration
Measured: Blood, hair and lung tissue are sampled during lung surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanislas Grassin Delyle, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949181
- Sponsor's protocol ID
- 2010/37
- Acronym
- Métaux/Poumons
- Status last verified
- May 2016
- First submitted
- 19 Sep 2013
- Last updated
- 3 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Blood, Hair and Lung Metals/Metalloids Concentration (Cadmium, Iron, Copper, Nickel, Chrome, Arsenic, Vanadium, Beryllium, and Zinc) and Lung Cancer or Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT01949181
- Acronym / sponsor ID
- Métaux/Poumons / 2010/37
- Keywords
- Metals, Metalloids, Blood, Hair, Lung, Lung cancer, Chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- 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.
Prospective research to study the relationship between concentrations of metals/metalloids in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary cancer | Experimental | Procedure: Lung surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of 18 to 75 years of age.
- Patients admitted for lung resection (either cancerous or non-cancerous) or lung transplant
Key exclusion criteria (1 listed)
- Patients with mental or physical conditions that prevent them giving their agreement for the study
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 |
|---|---|---|
| Lung surgery | Procedure or surgery | Pulmonary cancer |
Primary outcome
Metals/metalloids concentration
Time frame: Blood, hair and lung tissue are sampled during lung surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
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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.
Stanislas Grassin Delyle study chair
Hôpital Foch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung surgery in people with Lung Cancer and Chronic Obstructive Pulmonary Disease, run by Hopital Foch at 2 sites in France.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Metals/metalloids concentration (time frame: Blood, hair and lung tissue are sampled during lung surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2016.