Feasibility of a New Technology for Isolating Circulating Tumour Cells
NCT ID: NCT03979339
Last Updated: 2021-10-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
76 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-03-11
Study Completion Date
2023-12-31
Brief Summary
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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.
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.
Detailed Description
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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.
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.
Conditions
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HER2-positive Metastatic Breast Cancer
Ovarian Cancer
Hormone-resistant Prostate Cancer
Circulating Tumor Cell
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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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)
Group Type
EXPERIMENTAL
Blood sample collection
Intervention Type
PROCEDURE
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.
Interventions
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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.
Intervention Type
PROCEDURE
Eligibility Criteria
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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
* 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
* Patient under guardianship or curatorship
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Centre Oscar Lambret
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Emilie KACZMAREK, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Oncology Department - Centre Oscar Lambret
Locations
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Centre Oscar Lambret
Lille, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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References
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Related Links
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https://www.ncbi.nlm.nih.gov/pubmed/29290959
Circulating tumor cells: potential markers of minimal residual disease in ovarian cancer? a study of the OVCAD consortium
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697683/
The added value of circulating tumor cells examination in ovarian cancer staging
https://www.ncbi.nlm.nih.gov/pubmed/26923772
Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer
Other Identifiers
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2019-A01187-50
Identifier Type: OTHER
Identifier Source: secondary_id
CTC-SMMiL-E-1901
Identifier Type: -
Identifier Source: org_study_id