Feasibility of a New Technology for Isolating Circulating Tumour Cells

NCT03979339 | Unknown

• 2 other identifiers: CTC-SMMiL-E-19012019-A01187-50
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Metastatic Breast Cancer; Ovarian Cancer; Hormone-resistant Prostate Cancer; Circulating Tumor Cell

Keywords

Circulating Tumour Cells; Selected cancer patients; New technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Description of the isolated circulating cell

  within 24 hours after inclusion (blood sample collection)

• Percentage of cases with identified circulating tumor cells after frozen storage

  within 24 hours after inclusion (blood sample collection)

Study Arms (1)

blood sample collection

EXPERIMENTAL

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

Interventions

Blood sample collection 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.

blood sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding woman
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

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Related Links

• Circulating tumor cells: potential markers of minimal residual disease in ovarian cancer? a study of the OVCAD consortium
• 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

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emilie KACZMAREK, MD

  Medical Oncology Department - Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Vanseymortier

CONTACT

+33 (0)3 20 29 59 18; promotion@o-lambret.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 7, 2019
• Study Start: March 11, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)