Clinical trials

The HYPNO-AJA 2 study is a prospective single-center interventional clinical trial conducted at the Institut Bergonié to evaluate the effectiveness of hypnosis in reducing anxiety and chemotherapy-related symptoms in adolescents, young adults (AYAs), and young women undergoing cancer treatment. The study focuses on patients aged 15-39 with sarcoma or germ cell tumors and women aged 15-49 with breast cancer receiving neoadjuvant chemotherapy. Cancer treatment in AYAs is frequently associated with high levels of psychological distress, particularly anxiety related to chemotherapy sessions, invasive procedures, and repeated hospitalizations. Previous studies suggest that hypnosis may help reduce anxiety, pain, nausea, and emotional distress in oncology patients, but evidence remains limited in AYA populations and specific cancer types such as sarcoma, germ cell tumors, and breast cancer. HYPNO-AJA 2 aims to address this gap by assessing the feasibility, safety, and therapeutic value of hypnosis during chemotherapy. The study's primary objective is to determine whether hypnosis can significantly reduce anxiety symptoms during chemotherapy. Secondary objectives include evaluating its effects on nausea and vomiting, pain, medication consumption (anxiolytics and antiemetics), quality of life, body image perception, and patient satisfaction. The trial will include 70 participants divided into two cohorts: * 35 hospitalized patients with sarcoma or germ cell tumors; * 35 outpatients with breast cancer treated in a day hospital setting. Eligible participants must be newly diagnosed, treated at Institut Bergonié, and receiving chemotherapy based on anthracyclines and/or alkylating agents. Patients with contraindications to hypnosis, severe psychiatric or cognitive disorders, recent hypnosis exposure, or inability to comply with follow-up procedures are excluded. The intervention consists of a hypnosis session performed during the second chemotherapy cycle by a specialized oncology nurse trained in Ericksonian hypnosis and pain management. Sessions will last between 30 and 60 minutes and take place in a private and comfortable environment. The hypnosis procedure includes a preparatory discussion, hypnotic induction, progressive return to normal consciousness, and debriefing adapted to the patient's needs. Anxiety levels will be assessed using a Visual Analog Scale (VAS-Anxiety) before and after chemotherapy cycles 1, 2, and 3. Cycle 2 includes hypnosis, whereas cycles 1 and 3 do not. The primary endpoint is the difference in anxiety levels after cycle 2 compared with cycle 3. Secondary outcomes will evaluate chemotherapy-induced nausea and vomiting using the PRO-CTCAE system, pain intensity, medication use, quality of life through the EORTC QLQ-C30 questionnaire, body image changes using the Body Image Scale, and satisfaction with hypnosis sessions. The planned enrollment period is 18 months, with a total study duration of 24 months and individual patient participation lasting approximately six months. Statistical analyses will compare anxiety scores after chemotherapy with and without hypnosis using paired statistical tests. Based on preliminary results from the earlier HYPNO-AJA-1 pilot study, the sample size is expected to provide more than 90% statistical power to detect clinically meaningful reductions in anxiety. The investigators expect hypnosis to improve patients' psychological well-being, reduce symptom burden and medication use, enhance quality of life and body image acceptance, and strengthen the therapeutic relationship between patients and caregivers. More broadly, the study may support the integration of hypnosis into supportive oncology care pathways as a low-cost, non-pharmacological intervention adapted to young cancer patients.

Breast cancer, the most common cancer in women, is increasingly managed as a chronic disease thanks to therapeutic advances. However, treatments such as chemotherapy and hormonotherapy often induce premature menopause in younger women, leading to skin aging, atrophy, and distressing symptoms that negatively affect quality of life. These cutaneous effects are frequently overlooked despite their psychological and social impact. Hyaluronic acid injections, already well established in aesthetic and reconstructive medicine, may offer a safe, minimally invasive option to restore skin quality, improve self-esteem, and enhance overall well-being in breast cancer survivors. This study aims to assess their efficacy and safety in this specific population.

This is a prospective, single-centre, observational study. The analysis of samples of pancreatic tumours and/or metastases taken during biopsy or surgery will lead to the determination of the level of expression of convertases in patients with pancreatic cancer and could be used as an additional prognostic means reinforcing those currently used.

Single-centre, retrospective and prospective observational study. This study aims to evaluate the dose delivered by radiation to the tumour and organs at risk, as a factor predicting response and the appearance of toxicities. Dosimetric calculations are made for each treatment using scintigraphic images acquired following injection of 177Lu-PSMA-617.

This study aims to compare the one-year survival benefit of the association of cryoablation-pembrolizumab-pemetrexed-carboplatin versus pembrolizumab-pemetrexed-carboplatin in metastatic lung adenocarcinoma patients. This is a multicenter, prospective, open-labeled, 2-arm comparative randomized (1:1) phase III trial. Patients will be randomized with a 1:1 ratio into: * Arm A (experimental arm): cryoablation of one visceral lesion or bone metastasis excluding liver and sclerotic bone metastases combined with pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. * Arm B (standard arm): pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. Pembrolizumab and pemetrexed-carboplatin will be prescribed and administered at the dose recommended by market authorization. Cryoablation treatment should be performed within 6 weeks after the first administration of pembrolizumab. No treatment switching permitted.

Smooth muscle tumors of the uterus that do not fit the diagnostic criteria of benignity (such as leiomyomas) or malignancy (such as leiomyosarcomas) are called STUMP (smooth muscle tumor of uncertain malignant potential). A potential solution to this problem could be the application of predictive models using artificial intelligence (AI) to aid in the histopathological classification and prognosis of gynecological smooth muscle tumors. Deep learning using convolutional neural networks represents a specific class of machine learning, in which predictive models are trained by considering small groups of pixels in digital images and iteratively identifying salient features. In this study, we aim to develop deep learning models capable of accurately subclassifying and predicting the prognosis of gynecological smooth muscle tumors, based on histopathological features of hematoxylin and eosin (H\&E) slides. The aim is to develop a diagnostic and prognostic algorithm to help pathologists better classify and diagnose uterine smooth muscle tumors and predict their clinical course.

This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.

Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.

Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.

COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients. For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B: * Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis) * Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).

Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.

The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).

Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response.

Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.

This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease. In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling. Patients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.

A database of breast cancer patients was established at Institute Bergonié since the 90s , to assess patients' survival, assess practice, search for prognostic factors.

The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas \[RESOS\] / French expert network dedicated to the pathology of sarcomas \[RREPS\]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas \[NETSARC\]), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples. Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes. With the financial support of the French National Cancer Institute \[Institut National du cancer \[INCa\]).

Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752

This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin