Germ Cell Tumor of Testis

Testicular seminoma is a malignant tumor with a very high probability of cure. Current treatment approaches provide excellent long-term cancer outcomes. However, some standard treatments, including radiotherapy and platinum-based chemotherapy, may cause side effects both during treatment and many years after its completion. In the long term, these treatments may be associated with an increased risk of cardiovascular disease, metabolic disorders, and secondary malignancies. Because most patients with seminoma are successfully cured and have a long life expectancy, an important goal of modern cancer treatment is not only to achieve effective cancer control, but also to reduce the potential long-term adverse effects of treatment. One possible treatment approach is minimally invasive retroperitoneal lymph node dissection (RPLND), performed using laparoscopic or robot-assisted surgery. This procedure allows the disease stage to be determined more accurately by establishing whether cancer cells are present in the retroperitoneal lymph nodes. In some patients, surgery may potentially provide effective disease control without the need for subsequent radiotherapy or chemotherapy. However, currently available imaging methods, including computed tomography (CT), cannot always accurately determine whether individual retroperitoneal lymph nodes contain cancer cells. Studies have shown that in some patients undergoing RPLND for suspected lymph node involvement, no cancer cells are subsequently found in the removed lymph nodes. Therefore, there is a need to develop more accurate methods for identifying the lymph nodes that are most likely to be the first sites of cancer spread. Why Are We Studying Sentinel Lymph Nodes? This study investigates a method for identifying sentinel lymph nodes. Sentinel lymph nodes are the lymph nodes that first receive lymphatic drainage from the area of the primary tumor and may therefore be the first lymph nodes to which cancer cells spread. In this study, two complementary methods will be used to identify sentinel lymph nodes. The first involves the administration of a small amount of a radiopharmaceutical containing technetium-99m (Tc-99m), followed by single-photon emission computed tomography combined with computed tomography (SPECT/CT). During surgery, these lymph nodes will also be identified using a special gamma-detection device. The second method involves the use of indocyanine green (ICG), a fluorescent dye that allows the surgeon to visualize lymphatic drainage pathways and lymph nodes during surgery using near-infrared fluorescence imaging. The combination of these two methods may allow more accurate identification of sentinel lymph nodes and provide a better understanding of lymphatic drainage from testicular tumors. Why Are You Being Invited to Participate? You are being invited to participate because the characteristics of your disease meet the eligibility criteria for this study. The main purpose of the study is to determine how accurately and reliably sentinel lymph nodes can be identified in patients with testicular seminoma using a combination of radionuclide and fluorescence-guided techniques. The information obtained from this study may help to develop a more individualized approach to the surgical treatment of patients with seminoma. In the future, accurate identification of sentinel lymph nodes may make it possible to reduce the extent of surgery in selected patients, potentially decreasing surgical trauma and the risk of postoperative complications. At the same time, accurate detection of cancer involvement in lymph nodes may help identify patients who require additional anticancer treatment, such as systemic chemotherapy. It is important to understand that the approach being evaluated is investigational, and its advantages over currently established approaches have not yet been conclusively demonstrated. Therefore, participation in this study cannot guarantee any additional direct medical benefit to you. However, the information obtained from your participation may contribute to improving the diagnosis and treatment of patients with testicular seminoma in the future. Participation in this study is entirely voluntary. Before making your decision, you will have the opportunity to discuss the purpose of the study, the study procedures, possible benefits and risks, and alternative treatment options with your doctor. Your decision not to participate, or to withdraw from the study at a later time, will not affect your right to receive appropriate medical care.

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.