Oncología (médica)

A continuación se enumeran ensayos clínicos actuales.

Filtrar esta lista de estudios según la ubicación, el estado del estudio y más.

1. A Study To Evaluate Advanced Development Of Desorption Electrospray Ionization Mass Spectrometry For Intraoperative Molecular Diagnosis Of Brain Cancer

   Jacksonville, Fla.

   The purpose of this study is to explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; and to identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and, therefore, differentiate between IDH-mutant and wild-type gliomas.

2. A Study To Evaluate Immune-related Biomarkers For Pathological Response In Stage II-III HER2-positive Breast Cancer

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate invasive disease-free survival (iDFS) of multi-epitope HER2 vaccine vs. placebo in combination with ado-trastuzumab emtansine (TTT-DM1) in patients with stage II-III HER2+ breast cancer with residual disease post-neoadjuvant chemotherapy, and to evaluate the safety of multi-epitope HER2 vaccine given concurrently with T-DM1 maintenance therapy.

3. Sacituzumab Tirumotecan (MK-2870) In Combination With Pembrolizumab Versus Pembrolizumab Alone In Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

4. International Registry For Men With Advanced Prostate Cancer (IRONMAN)

   Jacksonville, Fla.

   The purpose of this registry is to collect detailed clinical, epidemiological and biological information from 5,000 male patients with advanced prostate cancer.

   The objectives are to describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally; to assess whether specific treatment patterns are associated with clinically significant adverse events, and evaluate potential interactions with concomitant medications or demographic factors; to identify associations between treatment sequences or combinations and overall survival; to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment; and to identify clinical and molecular disease subtypes that predict response to individual treatments, combinations, or sequences.

5. Testing The Use Of Chemotherapy After Surgery For High-Risk Pancreatic Neuroendocrine Tumors

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   The purpose of this study is to evaluate the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.

6. Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

   Jacksonville, Fla., Rochester, Minn.

   The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

7. Natural History Evaluation Among Female Breast Cancer Survivors With Endocrine Therapy-Induced Alopecia

   Mankato, Minn., Rochester, Minn., Albert Lea, Minn.

   The purpose of this study is to learn about potential side effects facing people who are undergoing treatments for their cancer, specifically, hair loss. While this is not a well-documented side effect of hormone-blocking medications (such as tamoxifen, letrozole, anastrozole, or exemestane), we have preliminary evidence that it is a problem for some patients getting this treatment.  This study will include some patients receiving the hormone therapy and some patients who are not, so we can better understand whether patients getting the hormonal therapy have more hair loss than patients who are not getting such.

8. Phase I/​II Study Of [225Ac]Ac-PSMA-R2 In PSMA-positive Prostate Cancer, With/​Without Prior 177Lu-PSMA RLT

   Rochester, Minn.

   This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.

9. Testing The Addition Of An Anti-cancer Drug, Selinexor, To The Usual Chemotherapy Treatment (Temozolomide) For Brain Tumors That Have Returned After Previous Treatment

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of phase 1 of this trial is to determine the maximum tolerated dose of temozolomide followed by selinexor in recurrent glioblastoma patients as determined by dose-limiting toxicities [DLTs] and the total toxicity profile.

   The purpose of phase 2 of this trial is to evaluate the effectiveness of sequentially administering temozolomide and selinexor in recurrent glioblastoma as determined by progression-free survival [PFS].

10. Serum Derived From Patient Donors With Paraneoplastic Pemphigus (PNP) to Be Used as a Positive Control for PNP Test

    Rochester, Minn.

    The purpose of this study is to obtain serum from patients with certain rare immunobullous diseases (e.g., paraneoplastic pemphigus, laminin-332 pemphigoid) to replenish a source of positive control for our clinical testing (e.g., Mayo test codes PNPAB, RSBV).  

    • To verify the performance characteristics of anti-Paraneoplastic Pemphigus (PNP) serum and validate its use as a positive control in PNP test.  

    • Serum from patients with PNP will be used for a positive control for the PNP test upon successful validation. 

    Background:  

    For various rare immunobullous diseases, detection of a circulating autoantibody is necessary for accurate diagnosis. As a CLIA requirement, every clinical test run requires positive and negative controls for quality control.  Currently, we use either archived sera or commercially available sera from patients with known relevant immunobullous diseases as a structural integrity positive control of rat bladder or transfected cells, which are the substrates for these indirect immunofluorescence tests.  

    While we have no difficulty locating negative control sera, it is challenging to source positive control sera, due to the rarity of these diseases. Specifically, commercial positive control serum is no longer available for purchase and only limited archived material is available.