Feasibility of a New Technology for Isolating Circulating Tumour Cells

Ovarian Cancer Clinical Trial

— CTC-SMMiL-E  

Official title:

Feasibility of a New Technology for Isolating Circulating Tumour Cells in Selected Cancer Patients and Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979339
• Other study ID #: CTC-SMMiL-E-1901
• Secondary ID: 2019-A01187-50
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: December 2023

Study information

• Verified date: October 2021
• Source: Centre Oscar Lambret
• Contact: Marie Vanseymortier
• Phone: +33 (0)3 20 29 59 18
• Email: promotion[@]o-lambret.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulating Tumor Cell
• HER2-positive Metastatic Breast Cancer
• Hormone-resistant Prostate Cancer
• Neoplastic Cells, Circulating
• Ovarian Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of cases with identified circulating tumor cells.	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)	within 24 hours after inclusion (blood sample collection)
Secondary	Description of the isolated circulating cell	Describe the different characteristics of these cells: size, cytological characteristics, number ...; These informations will allow to characterize the isolated circulating cells.	within 24 hours after inclusion (blood sample collection)
Secondary	Percentage of cases with identified circulating tumor cells after frozen storage	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)	within 24 hours after inclusion (blood sample collection)

External Links

•   Circulating tumor cells: potential markers of minimal residual disease in ovarian cancer? a study of the OVCAD consortium
•   Predictive value of circulating tumor cells (CTCs) captured by microfluidic device in patients with epithelial ovarian cancer
•   The added value of circulating tumor cells examination in ovarian cancer staging
•   Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer