Non Small Cell Lung CancerNCT00763607
Retrospective Study Evaluating IGF1R And p95HER2 as Prognostic Factors in Non Small Cell Lung Cancer (NSCLC)
An observational study of Non Small Cell Lung Cancer, run by Armando Santoro, MD at 1 site in Italy.
Trial summary
Aim of the study is to evaluated the role of IGF1R and p95HER2 on prognosis in radically resected non small cell lung cancer patients The primary objective is to correlate the expression of IGF1R and p95HER2 with survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Protein expression by immunohistochemistry and immunofluorescence
- How many people
- 454 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2007to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Radically resected non small cell lung cancer patients
Who may be able to join
- Radically resected non small cell lung cancer patients with tumor tissue available
Who cannot join
- Tumor tissue not available
- Clinical data not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study Evaluating IGF1R And p95HER2 as Prognostic Factors in Radically Resected Non Small Cell Lung Cancer
Aim of the study is to evaluated the role of IGF1R and p95HER2 on prognosis in radically resected non small cell lung cancer patients
The primary objective is to correlate the expression of IGF1R and p95HER2 with survival.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Protein expression by immunohistochemistry and immunofluorescence
- Keywords
- non small cell lung cancer patients
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein expression by immunohistochemistry and immunofluorescenceGenetic
Protein expression by immunohistochemistry and immunofluorescence
| Study group | Role | What they receive |
|---|---|---|
| 1 | Radically resected Non small cell lung cancer patients in stage I-III Receives: Genetic: Protein expression by immunohistochemistry and immunofluorescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of different biomarkers with survival
Measured: At the end of enrollment
Secondary outcomes (1)
Association of a specific biomarker with patient's characteristics
Measured: At the end of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armando Santoro, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armando Santoro, MD, Istituto Clinico Humanitas
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763607
- Sponsor's protocol ID
- ONC/OSS-02/2007
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2008
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study Evaluating IGF1R And p95HER2 as Prognostic Factors in Radically Resected Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00763607
- Acronym / sponsor ID
- ONC/OSS-02/2007
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- non small cell lung cancer patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Armando Santoro, MDUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Oct 2008 (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.
Aim of the study is to evaluated the role of IGF1R and p95HER2 on prognosis in radically resected non small cell lung cancer patients
The primary objective is to correlate the expression of IGF1R and p95HER2 with survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Genetic: Protein expression by immunohistochemistry and immunofluorescenceRadically resected Non small cell lung cancer patients in stage I-III |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Radically resected non small cell lung cancer patients
Key inclusion criteria (1 listed)
- Radically resected non small cell lung cancer patients with tumor tissue available
Key exclusion criteria (2 listed)
- Tumor tissue not available
- Clinical data not available
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 |
|---|---|---|
| Protein expression by immunohistochemistry and immunofluorescenceProtein expression by immunohistochemistry and immunofluorescence | Genetic | 1 |
Primary outcome
Association of different biomarkers with survival
Time frame: At the end of enrollment
1 secondary outcome
Association of a specific biomarker with patient's characteristics
Time frame: At the end of enrollment
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 10 Sep 2022.
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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.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Armando Santoro, MD at 1 site in Italy.
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 1 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: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Association of different biomarkers with survival (time frame: At the end of enrollment). 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 10 Sep 2022.