Clinical trials

This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.

CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept(1) to assess the clinical utility of ctDNA monitoring combined with 68Ga-FAPI-46-PET-CT imaging upon ctDNA detection for the surveillance of patients with a non-metastatic TNBC at high risk of relapse. The study has two steps. In Step 1, patients who have completed the treatments for a localized TNBC will undergo ctDNA monitoring every \~4 months (± 2 weeks). In Step 2, patients for whom ctDNA will be detected will then be randomized between an observation arm, in which monitoring will continue until the detection of a clinical relapse, and an experimental arm, in which the ctDNA detection will be revealed to both the patient and the clinician: patients will then undergo a 18F-FDG PET-CT and a 68Ga-FAPI-46-PET-CT, in addition to whatever workup the investigator will deem necessary.

The IMMUNO-TET trial aims to assess the feasibility of characterising the immune environment of TETs and the constitutional and somatic molecular profiles of patients with localised thymic epithelial tumour (TET).

The ProActIF-01 trial aims to assess the feasibility of a supervised 8-week combined APA and nutrition individualized program, in advanced digestive cancer patients.

This clinical study aims to determine if skipping breast and axillary surgery could provide similar control of local and distant disease, with fewer complications and better quality of life, for triple-negative breast cancer patients in complete response after neoadjuvant chemo-immunotherapy. Patients will be randomised into 2 groups : * Control arm will receive the standard treatment, including surgery * Experimental arm will receive the standard treatment, except surgery

The aim of this study is to evaluate the feasibility of performing a first screening for bronchopulmonary cancer by thoracic scanner in a French cohort within a dedicated, effective and structured network in the pilot centers participating in the study.

The aim of the COVAR project is to achieve reliable classification of as many variants of interest as possible from the French OncoGenetics Database (FrOG, https://frog-db.fr/) in order to use them for the genetic counseling. The results obtained through this study will have a major impact on clinical management of the patients and their families conducting in some cases to propose a prophylactic surgery.

Malnutrition is a major challenge in cancer nutrition, affecting approximately 40% of cancer patients and having negative consequences on treatment efficacy, quality of life, and prognosis. It must be detected and managed early, based on clinical and laboratory criteria defined by the HAS recommendations. To address this, several nutritional strategies are available, ranging from fortified oral feeding to artificial nutrition. Enteral nutrition, which is more physiological and carries fewer risks than parenteral nutrition, is recommended as the first-line treatment. Tools such as personalized care plans and guidelines help tailor patient care. However, enteral nutrition remains underutilized in clinical practice, despite the recommendations. The ADHENUTE study, conducted at the Institut Curie, showed low compliance with recommendations (31%) and a tendency to favor oral nutritional supplements, even in severely malnourished patients. The lack of traceability of decisions makes it difficult to identify barriers, although patient refusal is sometimes mentioned. To improve this situation, corrective measures have been implemented: * for patients, through educational workshops to help them better understand and accept enteral nutrition; * for healthcare providers, through training sessions to address reservations and enhance knowledge. A third phase of the study aims to evaluate the impact of these actions, with the goal of increasing adherence to recommendations and the use of enteral nutrition.

The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients.

The study will evaluate the detection of tumor-antigen specific immune cells in cancer patients in whom the role of the immune system is suspected.

The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

Eclectic is a strategy trial; once the class of treatment (endocrine therapy or chemotherapy) has been allocated according to 16α-18F-fluoro-17β-oestradiol (18F-FES) Positron Emission Tomography/Computed Tomography (PET/CT) results and circulating tumor biomarkers, clinicians will decide which treatment to use.

Assessment of the relevance of a new medical imaging test, FAPI PET, which could detect progression or relapse earlier than other tests currently available. Ultimately, it could enable early forms of pancreatic cancer to be detected and used for screening. In addition to the usual examinations prescribed, FAPI PET scans will be repeated at several points in the treatment process. All study patients must first have been included in the Homing cohort (NCT 04363983, APHP promotion). Clinical characteristics, judgement criteria and results of biological or imaging examinations carried out as part of this cohort will be shared. Patient follow-up and participation in the study ends when conventional imaging (CT and MRI) shows disease progression, relapse or death.

Multi-cohort exploratory prospective study. Participation in the ALCINA 4 study does not change the standard management of the patient, including the treatments administered. A sampling schedule will be set up for each cohort. Depending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples (or more) taken per patient for up to 18, 24 or 36 months. If a specific tumor sample is required, it will be collected only once during the study.

The H3RAKLES trial would allow patients with a progressive metastatic breast cancer to have access to one more line of systemic therapy. Patients included in this trial will have already received at least two lines of chemotherapy (and potentially several lines of endocrine therapy for patients with a HR+ disease). In this setting, few treatments have demonstrated a clinically meaningful benefit, and any additional option is valuable. Furthermore, the pre-clinical and clinical rationale indicate a high probability of clinical benefit, as previously shown in Table 1, with all patients treated with trastuzumab and a TKI targeting HER2 displaying a response. Besides, with several years of hindsight for the combination of lapatinib, trastuzumab and capecitabine, we expect excellent tolerance with the same treatment without capecitabine. The H3RAKLES single-arm phase II trial will evaluate the combination of tucatinib, a HER2 TKI, and trastuzumab, a HER2-directed antibody in patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation. To demonstrate the actionability of ERBB3 mutations, all patients will receive a combination of trastuzumab and tucatinib, in 3-weeks cycles.

Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. Multicentric, controlled, randomized and double-blind label study.

SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast, Head and Neck Cancer, advanced stage treatment-naïve cervical or vulva cancer and sarcoma (breast angiosarcoma and uterine sarcoma) cancers. This study will allowed to identify new molecular and/or immunological biomarkers associated with clinical and biological features of the tumors. All patients will receive standard treatment according to the stage of the diseases and usual procédures.

This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.

A biopsy of a tumor lesion (breast or other localisation) will be performed for processing to establish avatars (patient-derived organoids -PDO). A personalized tumorogram for each patient will be provided, based on the results of the drug screening (= tumor predicted as sensitive, intermediate, resistant or non-evaluable for each drug tested). Patients with an informative tumorogram will receive one of the recommended treatments (line N+1) in the event of tumor progression, administered according to standard procedures and validated at medical meetings specific to each center, and their fate will be monitored.

The goals of this study is to establish the prevalence of severe forms of FCR in the oncology hospital setting, which will require a specific psychotherapeutic response. Two cancer sites are targeted: breast and pulmonary cancers. Secondary objectives include: 1) Determining threshold scores for the FCRI's 9-item severity scale for each type of cancer; 3) To identify a simple item from the FCRI for early detection of FCR in everyday clinical practice, especially using a digital format.

Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.

This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients: * Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments. * Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.

Patient with histologically proven NSCLC in a metastatic stage, treatment naïve and eligible for first-line treatment with immune checkpoint inhibitor. Combination with chemotherapy is possible. Presence of a mutation after NGS analysis is required for ctDNA follow-up.

The goals of the NEUROBLASTOTEP trial is to compare the diagnostics performance of a the 18F-metafluorobenzylguanidine (18F-MFBG) Positron Emission Tomography / Computed Tomography scan (PET/CT) compared to 123I-metaiodobenzylguanidine (123I-MIBG scintigraphy (current gold standard) for imaging in neuroblastoma.

Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.