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Feasibility of a New Technology for Isolating Circulating Tumour Cells (CTC-SMMiL-E)

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ClinicalTrials.gov Identifier: NCT03979339
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:

This is a prospective interventional single-site research with a collection of biological samples.

The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.

Five groups will be constitued: at first the Group 0: Healthy volunteers included for the spike-in test; and then the four groups, Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer; Group 4: Healthy volunteers included as control).

In each group, the percentage of cases with identified circulating tumor cells will be estimated.


Condition or disease Intervention/treatment Phase
HER2-positive Metastatic Breast Cancer Ovarian Cancer Hormone-resistant Prostate Cancer Circulating Tumor Cell Procedure: Blood sample collection Not Applicable

Detailed Description:

This is a prospective interventional single-site research with a collection of biological samples ("Recherche Impliquant la Personne Humaine de type 2" according to French legislation).

First, a cohort of 20 healthy volunteers (Group 0: Healthy volunteers included for the spike-in test) will be constituted for the spike-in-test.

Then, recruitment of the three groups of 14 patients each (Group1: Metastatic HER2-positive breast cancer; Group 2: Advanced CA-125 positive ovarian cancer; Group 3: Metastatic PSA-positive castrate-resistant prostate cancer) and the control group of 14 healthy volunteers (Group 4: Healthy volunteers included as control) will be done in parallel.

In each group, the percentage of cases with identified circulating tumor cells will be estimated. Success will be defined as follows: the new technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach.

Circulating tumor cells (CTC) will be identified as followed:

  • Group 1 - putative circulating cells isolated by the new technique must be tested as HER-2 positive using Fluorescence In Situ Hybridization (FISH) to be regarded as true CTC
  • Group 2 - putative circulating cells isolated by the new technique must be tested as CA 125-positive using immuno-histochemistry (IHC) to be regarded as true CTC
  • Group 3 - putative circulating cells isolated by the new technique must be tested as PSA-positive using IHC to be regarded as true CTC For the healthy volunteers included as controls, if putative circulating cells are observed, these healthy volunteers will be tested against the three markers (HER2, CA-125 and PSA).

Failure will be defined as follows: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique.

The different characteristics of these cells will be described: size, cytological characteristics, number, etc.

Secondary collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to the capacity for isolating the CTC.

The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of a New Technology for Isolating Circulating Tumour Cells in Selected Cancer Patients and Healthy Volunteers
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: blood sample collection
For all participants whatever the group Groups 0 and 4: Healthy volunteers Group1: Metastatic HER2-positive breast cancer Group 2: Advanced CA-125 positive ovarian cancer Group 3: Metastatic PSA-positive castrate-resistant prostate cancer Participants will receive the following interventions because they are enrolled in the study: blood sample collection of 32mL (4x8mL in EDTA tubes)
Procedure: Blood sample collection
A total volume of 32 ml of blood will be collected in each subject and separated in 4 10-mL EDTA vacutainer tubes EDTA tubes of 8 mL each.




Primary Outcome Measures :
  1. Percentage of cases with identified circulating tumor cells. [ Time Frame: within 24 hours after inclusion (blood sample collection) ]

    To assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients.

    In each group, the percentage of cases with identified circulating tumor cells will be estimated.

    Success: the technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach.

    Failure: the technique failed to identify circulating tumor cells, either due to a technical issue, or because there was no cell identified by the new technique, or lastly because the identified cells were negative by the standard FISH or IHC technique.

    To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:

    • HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
    • CA 125-positive using immuno-histochemistry (IHC) (Group 2)
    • PSA-positive using IHC (Group 3)


Secondary Outcome Measures :
  1. Description of the isolated circulating cell [ Time Frame: within 24 hours after inclusion (blood sample collection) ]

    Describe the different characteristics of these cells: size, cytological characteristics, number ...

    These informations will allow to characterize the isolated circulating cells.


  2. Percentage of cases with identified circulating tumor cells after frozen storage [ Time Frame: within 24 hours after inclusion (blood sample collection) ]

    To assess the ability of the new technology to isolating CTC

    As secondary collected, collected samples will be frozen, and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to our capacity for isolating the CTC.

    In each group, the percentage of cases with identified circulating tumor cells will be estimated.

    To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:

    • HER-2 positive using Fluorescence In Situ Hybridization (FISH) (Group 1)
    • CA 125-positive using immuno-histochemistry (IHC) (Group 2)
    • PSA-positive using IHC (Group 3)



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:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • Registered with a social security system
  • Signed, IRB-approved written informed consent
  • Belonging to one of the following group:
  • Group 1 - HER-2 positive breast cancer, defined as followed: histologically-proven, HER-2 positive breast cancer, with metastasis (stage IV) requiring first-line treatment
  • Group 2 - Advanced ovarian cancer, defined as followed: histologically-proven, stage III or IV ovarian cancer requiring first-line chemotherapy
  • Group 3 - Metastatic prostate cancer, defined as followed: histologically-proven, stage IV, castrate-resistant prostate cancer requiring chemotherapy with docetaxel or treatment with 2nd generation hormonal therapy (e.g. enzalutamide or abiraterone)
  • Groups 0 and 4 - Healthy volunteers defined as followed: No prior personal history of malignant disease

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Patient under guardianship or curatorship

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): NCT03979339


Contacts
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Contact: Marie Vanseymortier +33 (0)3 20 29 59 18 promotion@o-lambret.fr

Locations
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France
Centre Oscar Lambret Not yet recruiting
Lille, France, 59020
Contact: Emilie KACZMAREK, MD    03 20 29 59 59    e-kaczmarek@o-lambret.fr   
Principal Investigator: Emilie KACZMAREK, MD         
Sub-Investigator: Audrey MAILLIEZ, MD         
Sub-Investigator: Nicolas PENEL, MD, PhD         
Sub-Investigator: Delphine HUDRY, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
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Principal Investigator: Emilie KACZMAREK, MD Medical Oncology Department - Centre Oscar Lambret

Additional Information:
Publications:

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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT03979339     History of Changes
Other Study ID Numbers: CTC-SMMiL-E-1901
2019-A01187-50 ( Other Identifier: ANSM )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
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
Keywords provided by Centre Oscar Lambret:
Circulating Tumour Cells
Selected cancer patients
New technology
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes