Urothelial CarcinomaDP-PAN-CANCERNCT06967961
Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers
A study testing For each enrolled patient, the sample described below will be collected as specific intervention intended for research purposes: in people with Urothelial Carcinoma and Renal Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Renal Cancer, Prostate Adenocarcinoma
- What is being tested?
- For each enrolled patient, the sample described below will be collected as specific intervention intended for research purposes:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2025to 23 Jul 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Oncopole Claudius Regaud, IUCT-O
Toulouse, 31059
Thibaud VALENTIN, MD, 0033 5 31 15 51 70, valentin.thibaud@iuct-oncopole.fr
Thibaud VALENTIN, MD
About this study
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)
- Being tested
- For each enrolled patient, the sample described below will be collected as specific intervention intended for research purposes:
- Keywords
- metastatic cancers, Double Positive Circulating cells, liquid biopsy
- Medical subject headings
- Carcinoma, Transitional Cell, Kidney Neoplasms, Melanoma, Sarcoma, Nonseminomatous germ cell tumor, Uterine Cervical Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: For each enrolled patient, the sample described below will be collected as specific intervention intended for research purposes: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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
Measured: 1 year after the Last Patient Last Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start23 Jul 2025
- Primary completion23 Jul 2029 (estimated)
- Study completion23 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967961
- Sponsor's protocol ID
- 24GENE19
- Acronym
- DP-PAN-CANCER
- Status last verified
- Jun 2026
- First submitted
- 5 May 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No