Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers

NCT ID: NCT06967961

Last Updated: 2025-07-29

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

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2029-07-23

Brief Summary

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A prospective, proof-of-concept pilot study in patients with metastatic cancers (9 types of cancers are studied) treated at the IUCT-O or possibly in other institutions. Eligible patients will be selected and informed of this study during a medical consultation for their cancer by medical oncologists. Then, with the patient's consent and before the start of anti-cancer treatment (whatever the line), a blood sample will be taken to detect DP-circulating cells by 2 different methods of analysis.

Each patient will participate in the study for one day. The methods of analysis will be: flow cytometry for all patients and either Parsotix® or CellSearch® depending on the type of cancer.

450 patients will be enrolled in total.

Detailed Description

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Conditions

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Urothelial Carcinoma Renal Cancer Prostate Adenocarcinoma Adenocarcinoma of Endometrium Cutaneous Melanoma Soft Tissue Sarcoma (STS) Nonseminomatous Germ Cell Tumor Seminomatous Germ Cell Tumor Upper Aerodigestive Tract Carcinoma Cervical Carcinoma

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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Patients with metastatic cancer

* Blood sample collection for circulating DP cell detection by flow cytometry and Cell Search analysis for the following patients:

* Cohort 1 : urothelial carcinoma
* Cohort 2 : renal carcinoma
* Cohort 3 : prostate adenocarcinoma
* Cohort 4 : upper aerodigestive tract carcinoma
* Cohort 5 : cervical carcinoma
* Cohort 6 : adenocarcinoma of endometrium
* Blood sample collection for circulating DP cell detection by flow cytometry and Parsotix analysis for the following patients:

* Cohort 7 : cutaneous melanoma
* Cohort 8 : soft tissue sarcoma
* Cohort 9 : seminomatous and nonseminomatous germ cell tumors

Group Type OTHER

For each enrolled patient, the sample described below will be collected as specific intervention intended for research purposes:

Intervention Type OTHER

A blood sample will be taken before initiation of the metastatic treatment line and will be analyzed by 2 distinct methods. The total blood volume withdrawn per patient is approximately 30mL.

Interventions

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For each enrolled patient, the sample described below will be collected as specific intervention intended for research purposes:

A blood sample will be taken before initiation of the metastatic treatment line and will be analyzed by 2 distinct methods. The total blood volume withdrawn per patient is approximately 30mL.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1\. Patients with one of the following cancer types: urothelial carcinoma, renal carcinoma, prostate adenocarcinoma, upper aerodigestive tract carcinoma, cervival carcinoma, adenocarcinoma of endometrium, cutaneous melanoma, soft tissue sarcoma, seminomatous and nonseminomatous germ cell tumors
* 2\. Metastatic disease for which the treatment (whatever the line) has not been initiated yet
* 3\. Age ≥ 18 years
* 4\. Patient affiliated to a French Social Security scheme
* 5\. Patient having signed his/her informed consent prior to inclusion in the study and prior to any specific procedure for the study.

Exclusion Criteria

* 1\. Patient with localized disease.
* 2\. Pregnant or breast-feeding women.
* 3\. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and/or procedures set out in the study protocol.
* 4\. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oncopole Claudius Regaud, IUCT-O

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Thibaud VALENTIN, MD

Role: CONTACT

0033 5 31 15 51 70

Facility Contacts

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Thibaud VALENTIN, MD

Role: primary

0033 5 31 15 51 70

Other Identifiers

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24GENE19

Identifier Type: -

Identifier Source: org_study_id

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