Clinical trial NCT06967961: Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers
Official title: Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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)
timeFrame: 1 year after the Last Patient Last Visit
Secondary outcomes:
measure: 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)
timeFrame: 1 year after the Last Patient Last Visit
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Oncopole Claudius Regaud, IUCT-O
Study officials:
References: