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Ex Vivo Expansion of Circulating Tumor Cells as a Model for Cancer Predictive Pharmacology (EXPEVIVO-CTC)

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ClinicalTrials.gov Identifier: NCT03797053
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
ScreenCell
Celenys
Imstar
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

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.


Condition or disease Intervention/treatment
Melanoma Circulating Tumor Cell Procedure: Biological sample

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Expansion ex Vivo Des Cellules Tumorales Circulantes Comme modèle de Pharmacologie prédictive Des Cancers. EXPEVIVO-CTC
Actual Study Start Date : April 6, 2015
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
Procedure: Biological sample

Biological sample performed :

  • before treatment
  • 1 months after the beginning of treatment
  • every tumoral assessment

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).

Procedure: Biological sample

Biological sample performed :

  • before treatment
  • 1 months after the beginning of treatment
  • every tumoral assessment




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 1 year ]
  2. Survival [ Time Frame: 3 years ]
  3. Survival [ Time Frame: 5 years ]
  4. Disease free Survival [ Time Frame: 1 year ]
  5. Disease free Survival [ Time Frame: 3 years ]
  6. Disease free Survival [ Time Frame: 5 years ]

Biospecimen Retention:   None Retained
Blood Sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

COHORT 1

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • None

COHORT 2 :

Inclusion Criteria :

  • 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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797053


Contacts
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Contact: Celeste Lebbe, MD PhD 142499590 ext +33 celeste.lebbe@aphp.fr
Contact: Matthieu RESCHE-RIGON, MD PhD 142499742 ext +33 matthieu.resche-rigon@univ-paris-diderot.fr

Locations
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France
Saint-Louis Hospital Recruiting
Paris, France, 75010
Contact: Celeste Lebbe, MD PhD    142499590 ext +33    celeste.lebbe@aphp.fr   
Contact: laetitia Da Meda    142499392 ext +33    laetitia.da-meda@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ScreenCell
Celenys
Imstar
Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03797053     History of Changes
Other Study ID Numbers: NI15009
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes