Clinical Research Directory

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not respond to treatment (refractory). Patients must have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers

This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.

Biomechanical Characterization of Skin Properties Using Impact Based-Analysis Method (IBAM)

Skin palpation remains, alongside visual inspection, the main clinical tool used to detect cutaneous abnormalities. However, palpation is a subjective, operator-dependent examination with limited sensitivity. There is currently no simple, real-time, low-cost, non-invasive tool available in routine clinical practice to objectively characterize the mechanical properties of skin tissue. The Impact-Based Analysis Method (IBAM) is a non-invasive biomechanical characterization technique developed by the MSME laboratory (Modélisation et Simulation Multi-Échelle, Université Paris Est Créteil) and the Mondor Institute for Biomedical Research (IMRB). It measures the mechanical response of soft tissue to a small mechanical impact, producing a quantitative indicator (Δt) that reflects local tissue stiffness. The reproducibility and sensitivity of this method have previously been demonstrated in preclinical models. This study aims to evaluate whether IBAM can distinguish malignant cutaneous tumors (basal cell carcinoma, squamous cell carcinoma, melanoma) from healthy surrounding skin based on their mechanical properties, and to characterize how these mechanical properties evolve from the tumor center toward clinically healthy margins. This is a prospective, single-center, ex vivo cohort study conducted at the Department of Plastic Surgery, Henri Mondor University Hospital (AP-HP), France. Patients undergoing surgical excision (with margins) for a suspected malignant cutaneous tumor will be included. Immediately after surgical excision, and before the specimen is sent for standard pathological examination, IBAM measurements will be performed ex vivo at three locations on the surgical specimen: the center of the tumor, the near peri-lesional area, and the distant peri-lesional area (presumed healthy margin). This additional step does not modify the patient's usual surgical or diagnostic management and does not require any additional intervention on the patient. The primary objective is to compare the IBAM-derived mechanical indicator (Δt) between malignant tissue and healthy tissue, using paired measurements from the same surgical specimen. The secondary objective is to describe the progressive change in mechanical properties from the tumor center to the healthy margin, which may help define more objective surgical safety margins in the future. A total of 10 patients will be included, based on a sample size calculation for a paired comparison (α = 5%, power = 80%). Statistical analysis will use paired Student's t-test or Wilcoxon signed-rank test, depending on data distribution (assessed by Shapiro-Wilk test). This research does not fall under the French "Loi Jardé" framework for research involving the human person, as it involves no additional intervention beyond standard care. It complies with the CNIL reference methodology MR-004. Patients receive individual written information and provide written consent or non-opposition prior to inclusion. Data are pseudonymized and securely stored. If confirmed, this method could provide surgeons with a simple, rapid, and objective tool to help differentiate malignant from healthy skin tissue intraoperatively, and to better define resection margins, with the ultimate goal of improving the surgical management of cutaneous malignancies.

A Disposable Negative Pressure Wound Therapy Device (SNaP) to Promote Wound Healing in the Lower Limbs Following Mohs Micrographic Surgery for Non-melanoma Skin Cancer

This clinical trial studies whether a disposable negative pressure wound therapy (dNPWT) device, SNaP Wound Care System (Ultraportable Mechanically Powered Negative Pressure Wound Therapy) (SNaP), promotes wound healing in the lower limbs in patients that have undergone Mohs micrographic surgery (Mohs surgery) for non-melanoma skin cancer. Mohs surgery is a surgical technique used to treat skin cancer. Individual layers of cancerous tissue are removed and examined under a microscope one at a time until all cancerous tissue has been removed. It is an important part of removing skin cancer, but it often leads to soft-tissue defects and reconstructive challenges, especially in high-tension areas like the lower limbs. Typically, these wounds are managed by leaving them open and allowing them to heal from the base up or are reconstructed by transferring healthy skin from another part of the body. Negative pressure wound therapy (NPWT) is a wound dressing system that continuously or intermittently applies subatmospheric pressure to the surface of a wound to draw out fluid and promote healing. The SNaP device is a dNPWT device for lower leg wound healing designed for increased portability and ease of use outside of a hospital setting. It is a modification of traditional NPWT devices that uses springs to generate pressure, making it lighter and more user-friendly than traditional devices that rely on electrically powered pumps. This may be a more effective way to promote wound healing in the lower limbs following Mohs surgery for non-melanoma skin cancer.

Technology-Enabled Activation of Skin Cancer Screening for Stem Cell Transplant Survivors and Their Primary Care Providers, TEACH Study

This trial studies the impact of a 12-month invention focused on early detection of skin cancer and timely follow up in patients who underwent stem cell transplant and their primary care providers. Some stem cell transplant survivors may develop complications related to the treatment they received. Many of these complications may not be known for years after the treatment and preventive measures can be taken to reduce the chances that a complication will occur and encourage early detection. This study focuses on one complication that stem cell transplant survivors are at high risk of developing - skin cancer. An early diagnosis of skin cancer is important since the cancer is usually smaller, requires less extensive treatments, and has better outcomes. Teaching skin self-examination and encouraging patients to alert doctors to skin changes may provide an important opportunity for early detection of skin cancer.

MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma

This trial studies how well MoleMapper, Visiomed, and confocal microscopy work in screening participants for melanoma. Analyzing images (photographs) made with three different portable imaging systems may be as good as a visit to a dermatologist's office for finding melanomas before they can spread.

Cancer Genetic Testing in Ethnic Populations

This clinical trial examines the integration of cancer genetic testing in various ethnic populations. Studying individuals and families at risk of cancer may help identify cancer genes and other persons at risk. The information from this study may provide an opportunity for cancer risk stratification and individualized screening in these ethnic populations.

Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

This pilot early phase I trial studies how well encorafenib, binimetinib, and nivolumab work in treating patients with BRAF mutant stage IIIC-IV melanoma. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with nivolumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may kill more tumor cells.