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

Not Applicable

Not yet recruiting

• 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

• Registration Number: NCT06967961
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-30
• Primary Completion: 2029-07-01
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)	1 year after the Last Patient Last Visit	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.

Secondary Outcome Measures

Name	Time	Method
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	It is defined as the ratio of the number of patients presenting DP cells (detected by the concerned technique) by the total number of patients

Trial Locations

Locations (1)

Oncopole Claudius Regaud, IUCT-O; 🇫🇷 Toulouse, France