Malignant Pleural MesotheliomaNCT01865045
Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients
An observational study of Malignant Pleural Mesothelioma, run by Armando Santoro, MD at 1 site in Italy.
Trial summary
This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome. Sample size: around 150 patients based on the availability of tumor size Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Pleural Mesothelioma
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Dec 2017
- 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: Malignant pleural mesothelioma patients treated with vinorelbine as a second or later line chemotherapy with at least an objective response evaluation.
Who may be able to join
- MPM patients treated with vinorelbine in the ≥ second line setting will be retrospectively analyzed
- Patients will be selected based on the availability of tumor tissue
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient
This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome.
Sample size: around 150 patients based on the availability of tumor size
Read the detailed description
Vinorelbine has recently become an alternative option for palliation in selected pemetrexed-pretreated patients with malignant pleural mesothelioma (MPM). However, nowadays there are no definitive data about vinorelbine predictors of response in MPM patients. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.
In oncology a pharmacogenetic approach to customize the chemotherapy treatment according to individual as well as tumour genetic characteristics represents a modern and intriguing challenge. Recent studies have suggested that the expression levels of class III β-tubulin (TUBB3) or BRCA1, are related to a survival benefit from vinorelbine chemotherapy among patients with advanced solid malignancies, especially non-small cell lung cancer. There are no data about the predictive factors to vinorelbine in MPM patients. The identification of molecular predictors of effective therapy may allow in the future the development of better therapies.
- Conditions
- Malignant Pleural Mesothelioma
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no treatment | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR.
Measured: 2 months
Secondary outcomes (1)
Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) .
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 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
- NCT01865045
- Sponsor's protocol ID
- ONC/OSS-02/2012
- Status last verified
- Sep 2022
- First submitted
- 27 May 2013
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: not planned
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
- Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient
- ClinicalTrials.gov ID
- NCT01865045
- Acronym / sponsor ID
- ONC/OSS-02/2012
- Conditions
- Malignant Pleural Mesothelioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Armando Santoro, MDUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 May 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.
This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome.
Sample size: around 150 patients based on the availability of tumor size
Detailed description
Vinorelbine has recently become an alternative option for palliation in selected pemetrexed-pretreated patients with malignant pleural mesothelioma (MPM). However, nowadays there are no definitive data about vinorelbine predictors of response in MPM patients. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.
In oncology a pharmacogenetic approach to customize the chemotherapy treatment according to individual as well as tumour genetic characteristics represents a modern and intriguing challenge. Recent studies have suggested that the expression levels of class III β-tubulin (TUBB3) or BRCA1, are related to a survival benefit from vinorelbine chemotherapy among patients with advanced solid malignancies, especially non-small cell lung cancer. There are no data about the predictive factors to vinorelbine in MPM patients. The identification of molecular predictors of effective therapy may allow in the future the development of better therapies.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | –no treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Malignant pleural mesothelioma patients treated with vinorelbine as a second or later line chemotherapy with at least an objective response evaluation.
Key inclusion criteria (2 listed)
- MPM patients treated with vinorelbine in the ≥ second line setting will be retrospectively analyzed
- Patients will be selected based on the availability of tumor tissue
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR.
Time frame: 2 months
1 secondary outcome
Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) .
Time frame: 2 months
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.
- Individual participant dataSharing planned: No. not planned
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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 Malignant Pleural Mesothelioma, 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 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 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?
Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR. (time frame: 2 months). 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.