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

Sponsor
Centre Oscar Lambret (Other)
Overall Status
Recruiting
CT.gov ID
NCT03979339
Collaborator
(none)
76
Enrollment
1
Location
1
Arm
44.7
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Blood sample collection
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
N/A
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
Actual Study Start Date :
Mar 11, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of cases with identified circulating tumor cells. [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Oscar Lambret Lille France 59020

Sponsors and Collaborators

  • Centre Oscar Lambret

Investigators

  • Principal Investigator: Emilie KACZMAREK, MD, Medical Oncology Department - Centre Oscar Lambret

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT03979339
Other Study ID Numbers:
  • CTC-SMMiL-E-1901
  • 2019-A01187-50
First Posted:
Jun 7, 2019
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Neoplastic Cells, Circulating

Study Results

No Results Posted as of Oct 13, 2021