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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06967961
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut Claudius Regaud
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Arms & Interventions

Arms

Other: 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

Interventions

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Oncopole Claudius Regaud, IUCT-O, Toulouse 2972315, France

Status

Recruiting

Address

Oncopole Claudius Regaud, IUCT-O

Toulouse 2972315, , 31059

Site Contact

Thibaud VALENTIN, MD

[email protected]

0033 5 31 15 51 70

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