Metastatic CancerLiquid BiopsyNCT02666612
Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer
A study testing Blood samples in people with Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly treated with targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Blood samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,240 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2008to Aug 2023
- 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
- Patients with metastatic solid tumor
- Age> 18 years
- Signed consent
Who cannot join
- Patients with diseases associated with vascular lesions known.
- Patients protected by law, in accordance with Articles L1121-5 to L1121-8 of the Code of Public Health.
- Mental pathology that can interfere with the proper conduct of the study.
- Refusal of consent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
Jean Charles Soria, MD-PhD, 0142114291 ext. +33, soria@gustaveroussy.fr
About this study
Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly treated with targeted therapy.
- Conditions
- Metastatic Cancer
- Being tested
- Blood samples
- Keywords
- Patients
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic cancer | Other | Not described Receives: Procedure: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement and characterization of CEC and CEP and circulaing DNA rate using flow cytometry
Measurement and characterization of initial CEC and CEP circulaing DNA and their evolution under treatment
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startAug 2008
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Charles Soria, MD-PhD, Study chair, Gustave Roussy Cancer Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666612
- Sponsor's protocol ID
- 2008-A00585-50
- Other IDs
- 2008/1370
- Acronym
- Liquid Biopsy
- Status last verified
- Jan 2017
- First submitted
- 12 Aug 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer
- ClinicalTrials.gov ID
- NCT02666612
- Acronym / sponsor ID
- Liquid Biopsy / 2008-A00585-50
- Conditions
- Metastatic Cancer
- Keywords
- Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,240 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Aug 2008 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 28 Jan 2016 (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.
Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly treated with targeted therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic cancer | Other | Procedure: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with metastatic solid tumor
- Age> 18 years
- Signed consent
Key exclusion criteria (4 listed)
- Patients with diseases associated with vascular lesions known.
- Patients protected by law, in accordance with Articles L1121-5 to L1121-8 of the Code of Public Health.
- Mental pathology that can interfere with the proper conduct of the study.
- Refusal of consent.
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 samples | Procedure or surgery | Patients with metastatic cancer |
Primary outcome
Measurement and characterization of CEC and CEP and circulaing DNA rate using flow cytometry
Time frame: up to 2 years
Measurement and characterization of initial CEC and CEP circulaing DNA and their evolution under treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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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.
Jean Charles Soria, MD-PhD study chair
Gustave Roussy Cancer Campus
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 samples in people with Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris 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 3 inclusion and 4 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 26 Jan 2017. 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. 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?
Contact Jean Charles Soria, MD-PhD (0142114291 ext. +33, soria@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement and characterization of CEC and CEP and circulaing DNA rate using flow cytometry (time frame: up to 2 years). 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 26 Jan 2017.