MelanomaEXPEVIVO-CTCNCT03797053
Ex Vivo Expansion of Circulating Tumor Cells as a Model for Cancer Predictive Pharmacology
An observational study of Melanoma and Circulating Tumor Cell, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Several studies conducted over the past decade have shown that Circulating tumor cells (CTCs) can be used as a marker for predicting disease progression and survival in patients with early or metastatic cancer. A high number of CTCs correlate with aggressive disease, increased metastasis and decreased survival rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Circulating Tumor Cell
- What is being tested?
- Biological sample
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2015to 30 Jun 2019
- 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: Cohort1: Cohort of patients with stage III unresectable or IV metastatic melanoma patients Cohort 2: Cohort of patients with melanoma candidates for sentinel lymph node analysis
Who may be able to join
- Histologically confirmed cutaneous or mucosal melanoma (per American joint committee on cancer (AJCC) staging system) that is unresectable or metastatic
- No prior systemic anticancer therapy for unresectable/metastatic melanoma or clinical/radiological disease progression (RECIST1.1) if previously treated and before new treatment
- No prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as cutaneous carcinoma or cervix)
- followed in Saint Louis Hospital
- Tumor tissue available in Saint Louis Hospital
- Subjects must have signed and approved written informed consent form
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- No pregnancy
- Any positive test for hepatitis A virus, hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus
- Histologically confirmed cutaneous or mucosal melanoma
- Candidates for sentinel lymph node analysis and surgical recovery (this examination is in practice reserved for melanomas >1mm thick or ulcerated)
- No prior adjuvant anticancer therapy
- followed in Saint Louis Hospital
- Tumor tissue available in Saint Louis Hospital
- Subjects must have signed and approved written informed consent form
- No pregnancy
- Any positive test for hepatitis A virus, hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus
Who cannot join
- None
- COHORT 2 :
- None
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Saint-Louis Hospital
Paris, 75010
Celeste Lebbe, MD PhD, 142499590 ext. +33, celeste.lebbe@aphp.fr
laetitia Da Meda, 142499392 ext. +33, laetitia.da-meda@aphp.fr
About this study
Official title: Expansion ex Vivo Des Cellules Tumorales Circulantes Comme modèle de Pharmacologie prédictive Des Cancers. EXPEVIVO-CTC
Several studies conducted over the past decade have shown that Circulating tumor cells (CTCs) can be used as a marker for predicting disease progression and survival in patients with early or metastatic cancer. A high number of CTCs correlate with aggressive disease, increased metastasis and decreased survival rates.
Knowledge of metastasis mechanisms was mainly obtained from mouse models with CTCs after orthotopic transplants. The only possibility to study the patient's CTC subpopulations is to carry out ex-vivo expansion and develop an animal model with CTC xenograft. Because circulating blood collection is simple and non-invasive, CTCs can be used as a marker to track disease progression and survival in real time. CTCs could also guide therapeutic choice.
- Conditions
- Melanoma, Circulating Tumor Cell
- Being tested
- Biological sample
- Medical subject headings
- Melanoma, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sampleProcedure or surgery
Biological sample performed :
- before treatment
- 1 months after the beginning of treatment
- every tumoral assessment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 : metastatic cohort | Cohort1: Cohort of patients with stage III inoperable or IV metastatic melanoma This cohort will enable the achievement of objectives 1 (proof of concept) and 2 (establishment of prognostic and predictive value). Receives: Procedure: Biological sample | |
| Cohort 2 : adjuvant cohort | Cohort 2: Cohort of patients with melanoma who are candidates for sentinel lymph node analysis.
This group includes patients with melanoma in whom sentinel lymph node testing is performed. According to current French recommendations, these are patients whose primary melanoma has a Breslow index (thickness) of more than 1 mm or ulcerated primary melanoma (loss of the epidermis). Receives: Procedure: Biological sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutical response
Occurrence of clinical benefit (defined as Complete Response (CR), Partial Response (PR) or stable disease (SD)) and progressive disease based on the best overall response which depends on the tumour evaluations assessed using RECIST 1.1 criteria.
Measured: 6 months
Secondary outcomes (6)
Survival
Measured: 1 year
Survival
Measured: 3 years
Survival
Measured: 5 years
Disease free Survival
Measured: 1 year
Disease free Survival
Measured: 3 years
Disease free Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start6 Apr 2015
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ScreenCell, Celenys, Imstar, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797053
- Sponsor's protocol ID
- NI15009
- Acronym
- EXPEVIVO-CTC
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expansion ex Vivo Des Cellules Tumorales Circulantes Comme modèle de Pharmacologie prédictive Des Cancers. EXPEVIVO-CTC
- ClinicalTrials.gov ID
- NCT03797053
- Acronym / sponsor ID
- EXPEVIVO-CTC / NI15009
- Conditions
- Melanoma, Circulating Tumor Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ScreenCell, Celenys, Imstar, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 6 Apr 2015 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 8 Jan 2019 (actual)
- 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.
Several studies conducted over the past decade have shown that Circulating tumor cells (CTCs) can be used as a marker for predicting disease progression and survival in patients with early or metastatic cancer. A high number of CTCs correlate with aggressive disease, increased metastasis and decreased survival rates.
Knowledge of metastasis mechanisms was mainly obtained from mouse models with CTCs after orthotopic transplants. The only possibility to study the patient's CTC subpopulations is to carry out ex-vivo expansion and develop an animal model with CTC xenograft. Because circulating blood collection is simple and non-invasive, CTCs can be used as a marker to track disease progression and survival in real time. CTCs could also guide therapeutic choice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 : metastatic cohort | – | Procedure: Biological sampleCohort1: Cohort of patients with stage III inoperable or IV metastatic melanoma This cohort will enable the achievement of objectives 1 (proof of concept) and 2 (establishment of prognostic and predictive value). |
| Cohort 2 : adjuvant cohort | – | Procedure: Biological sampleCohort 2: Cohort of patients with melanoma who are candidates for sentinel lymph node analysis. This group includes patients with melanoma in whom sentinel lymph node testing is performed. According to current French recommendations, these are patients whose primary melanoma has a Breslow index (thickness) of more than 1 mm or ulcerated primary melanoma (loss of the epidermis). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort1: Cohort of patients with stage III unresectable or IV metastatic melanoma patients Cohort 2: Cohort of patients with melanoma candidates for sentinel lymph node analysis
Key inclusion criteria (16 listed)
- Histologically confirmed cutaneous or mucosal melanoma (per American joint committee on cancer (AJCC) staging system) that is unresectable or metastatic
- No prior systemic anticancer therapy for unresectable/metastatic melanoma or clinical/radiological disease progression (RECIST1.1) if previously treated and before new treatment
- No prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as cutaneous carcinoma or cervix)
- followed in Saint Louis Hospital
- Tumor tissue available in Saint Louis Hospital
Key exclusion criteria (3 listed)
- None
- None
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 |
|---|---|---|
| Biological sampleBiological sample performed : * before treatment * 1 months after the beginning of treatment * every tumoral assessment | Procedure or surgery | Cohort 1 : metastatic cohort, Cohort 2 : adjuvant cohort |
Primary outcome
Therapeutical response
Time frame: 6 months
Occurrence of clinical benefit (defined as Complete Response (CR), Partial Response (PR) or stable disease (SD)) and progressive disease based on the best overall response which depends on the tumour evaluations assessed using RECIST 1.1 criteria.
6 secondary outcomes
Survival
Time frame: 1 year
Survival
Time frame: 3 years
Survival
Time frame: 5 years
Disease free Survival
Time frame: 1 year
Disease free Survival
Time frame: 3 years
Disease free Survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: No
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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.
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 Melanoma and Circulating Tumor Cell, run by Assistance Publique - Hôpitaux de 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 16 inclusion and 3 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 8 Jan 2019. 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 Celeste Lebbe, MD PhD (142499590 ext. +33, celeste.lebbe@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutical response (time frame: 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 8 Jan 2019.