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

NCT06967961 | Recruiting

• 1 other identifier: 24GENE19
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

metastatic cancers; Double Positive Circulating cells; liquid biopsy

Outcome Measures

Primary Outcomes (1)

• Rate of patients presenting blood circulating DP cells detected by at least one of the two tested techniques (Flow Cytometry/ CellSearch® or Parsortix® according to the type of tumor)

  It is defined as the ratio of number of patients for whom DP cells were detected (by at least 1 of the 2 techniques) by the total number of patients.

  1 year after the Last Patient Last Visit

Secondary Outcomes (1)

• Rate of patients presenting blood circulating DP cells detected by each method of analysis (Flow Cytometry and CellSearch® or Parsortix® according to the tumor type)

  1 year after the Last Patient Last Visit

Study Arms (1)

Patients with metastatic cancer

OTHER

* 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

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

Interventions

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

Patients with metastatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• \. Metastatic disease for which the treatment (whatever the line) has not been initiated yet
• \. Age ≥ 18 years
• \. Patient affiliated to a French Social Security scheme

You may not qualify if:

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

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Oncopole Claudius Regaud, IUCT-O

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Kidney Neoplasms; Melanoma; Sarcoma; Nonseminomatous germ cell tumor; Uterine Cervical Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Central Study Contacts

Thibaud VALENTIN, MD

CONTACT

0033 5 31 15 51 70; valentin.thibaud@iuct-oncopole.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 5, 2025
• First Posted: May 13, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): July 23, 2029
• Study Completion (Estimated): July 23, 2029
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

FR (1)