Pleural NeoplasmsNCT01776385
The ISET (Isolation by Size of Epithelial Tumor Cells) and the CellSearch Methods in Malignant Pleural Mesothelioma
A study testing Blood sampling in people with Pleural Neoplasms and Mesothelioma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare distant metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Neoplasms, Mesothelioma, Pneumothorax
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Mar 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the patients:
- Age > 18 years
- Patient having been operated for a strong suspicion of a pleural malignant tumoral lesion corresponding to a primitive pleural mesothelioma
- Signed patient consent
- For the control subjects:
- Age > 18 years
- unhurt of any malignant or mild tumoral pathology or patients that must benefit from a surgical procedure for a benign lesion in other organ than the pleura or a pulmonary non tumoral lesion
- Signed patient consent
Who cannot join
- Patient with histories of cancer or the other synchronous cancer
- Patient with additives treatments
- Patient according to treatments additives others than protocols codified (in particular, platinum navelbine or gemcitabine platinum) for stages II
- HIV, hepatitis B or C infections
- Pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine
Nice, Alpes-Maritimes, 06001
About this study
Official title: Detection and Characterization of Circulating Tumor Cells in Patients With Malignant Pleural Mesothelioma: Towards a New Phase in the Understanding of the Natural History of This Cancer?
Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare distant metastases. There is now a sizable body of evidence that metastases could develop from circulating tumor cells (CTC) spread in blood before or during surgery. Thus, sensitive and specific detection of CTC in blood is considered as a potentially relevant predictive biomarker for patients with carcinomas. In exchange, the prognostic value of CTC in MPM has not yet been evaluated.
Indeed, the main goal for preoperative detection of CTC is to identify patients with high risk of recurrence after surgery, in order to perform more adapted therapeutic strategy. Despite several studies reported about CTC detection, methodological aspects concerning sensitivity, specificity and reproducibility have prevented a clear appraisal of their clinical impact. Thus, the aim of our study is to evaluate the presence and the prognostic value of CTC in MPM by a double approach. In our setting, cytopathological analysis of circulating non hematological cells (CNHC), of epithelial origin, isolated according to their size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic selection, identification and enumeration of circulating epithelial cells in peripheral blood (CellSearch method) is considered a promising approach.
- Conditions
- Pleural Neoplasms, Mesothelioma, Pneumothorax, Parathyroid Neoplasms, Benign Tumor of the Thyroid, Tumor of the Thyroid
- Being tested
- Blood sampling, Control Group
- Keywords
- [C08.785.640], (C08.528.778), [C19.642.713], mesothelium
- Medical subject headings
- Pleural Neoplasms, Mesothelioma, Pneumothorax, Parathyroid Neoplasms, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods
Control GroupOther
Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods
| Study group | Role | What they receive |
|---|---|---|
| Group patients | Experimental | Patients with Malignant Pleural Mesothelioma (all stages) Receives: Other: Blood sampling |
| Control group | Placebo comparator | Patients with pneumothorax or of benign tumor of the thyroid Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of presence / absence of CTC on the global survival
Value forecasts of the presence / absence of CTC on the global survival estimated by the estimation and the test of meaning at 0 of the immediate relative risk (fate ratio) in a model at proportional risk.
Measured: from Baseline in Systolic Blood Pressure at 6 months
Secondary outcomes (1)
Value forecasts of the number of CTC on the global survival estimated by the risk
Value forecasts of the number of CTC on the global survival estimated by the immediate relative risk Value forecasts of the presence / absence and the number of CTC on the survival without second offense(recurrence) or metastasis estimated by the immediate relative risk
Measured: from Baseline in Systolic Blood Pressure at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ILIE Marius, PhD, Principal investigator, LPCE- Hôpital de Pasteur - CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776385
- Sponsor's protocol ID
- 11-AOI-08
- Status last verified
- Feb 2018
- First submitted
- 23 Mar 2012
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Characterization of Circulating Tumor Cells in Patients With Malignant Pleural Mesothelioma: Towards a New Phase in the Understanding of the Natural History of This Cancer?
- ClinicalTrials.gov ID
- NCT01776385
- Acronym / sponsor ID
- 11-AOI-08
- Conditions
- Pleural Neoplasms, Mesothelioma, Pneumothorax, Parathyroid Neoplasms, Benign Tumor of the Thyroid, Tumor of the Thyroid
- Keywords
- [C08.785.640], (C08.528.778), [C19.642.713], mesothelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 28 Jan 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.
Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare distant metastases. There is now a sizable body of evidence that metastases could develop from circulating tumor cells (CTC) spread in blood before or during surgery. Thus, sensitive and specific detection of CTC in blood is considered as a potentially relevant predictive biomarker for patients with carcinomas. In exchange, the prognostic value of CTC in MPM has not yet been evaluated.
Indeed, the main goal for preoperative detection of CTC is to identify patients with high risk of recurrence after surgery, in order to perform more adapted therapeutic strategy. Despite several studies reported about CTC detection, methodological aspects concerning sensitivity, specificity and reproducibility have prevented a clear appraisal of their clinical impact. Thus, the aim of our study is to evaluate the presence and the prognostic value of CTC in MPM by a double approach. In our setting, cytopathological analysis of circulating non hematological cells (CNHC), of epithelial origin, isolated according to their size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic selection, identification and enumeration of circulating epithelial cells in peripheral blood (CellSearch method) is considered a promising approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group patients | Experimental | Other: Blood samplingPatients with Malignant Pleural Mesothelioma (all stages) |
| Control group | Placebo comparator | Other: Control GroupPatients with pneumothorax or of benign tumor of the thyroid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Patient having been operated for a strong suspicion of a pleural malignant tumoral lesion corresponding to a primitive pleural mesothelioma
- Signed patient consent
- Age > 18 years
- unhurt of any malignant or mild tumoral pathology or patients that must benefit from a surgical procedure for a benign lesion in other organ than the pleura or a pulmonary non tumoral lesion
Key exclusion criteria (5 listed)
- Patient with histories of cancer or the other synchronous cancer
- Patient with additives treatments
- Patient according to treatments additives others than protocols codified (in particular, platinum navelbine or gemcitabine platinum) for stages II
- HIV, hepatitis B or C infections
- Pregnant women
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 |
|---|---|---|
| Blood samplingBiological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods | Other | Group patients |
| Control GroupBiological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods | Other | Control group |
Primary outcome
Evaluation of presence / absence of CTC on the global survival
Time frame: from Baseline in Systolic Blood Pressure at 6 months
Value forecasts of the presence / absence of CTC on the global survival estimated by the estimation and the test of meaning at 0 of the immediate relative risk (fate ratio) in a model at proportional risk.
1 secondary outcome
Value forecasts of the number of CTC on the global survival estimated by the risk
Time frame: from Baseline in Systolic Blood Pressure at 6 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 23 Jul 2018.
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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.
ILIE Marius, PhD principal investigator
LPCE- Hôpital de Pasteur - CHU de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Pleural Neoplasms and Mesothelioma, run by Centre Hospitalier Universitaire de Nice at 1 site 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 8 inclusion and 5 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 23 Jul 2018. 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 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. Some participants in this study may receive a placebo. 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?
Evaluation of presence / absence of CTC on the global survival (time frame: from Baseline in Systolic Blood Pressure at 6 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 23 Jul 2018.