Active clinical trials for "Neoplasms"

Colorectal cancer (CRC) is the second leading cause of cancer death in the United States and affects men and women almost equally. The United States Preventative Services Task Force (USPSTF) currently recommends screening with any of three options, which include fecal testing, flexible sigmoidoscopy, or colonoscopy. Screening for CRC with fecal occult blood testing (using a guaiac-based test) done annually or biennially has been shown to decrease mortality 15-33% primarily through detection of early stage cancer. Guaiac fecal occult blood testing (gFOBT) has a known positive balance of benefit and risk in screening populations, is the least expensive, and is the preferred method of screening in 30-55% of patients. The fecal immunochemical test (FIT) offers significant improvements over the gFOBT, most notably that it is easier to use (requires fewer samples and no dietary or medication restrictions) and is more sensitive than the gFOBT with respect to detecting both CRC and precancerous adenomas. As a result of improved test performance and usability, in 2008 multiple professional societies endorsed the use of four types of FITs for colorectal cancer screening. Kaiser Permanente currently uses the OC-Micro FIT as the fecal screening test in all regions. In recent years, intensive efforts have been undertaken to identify blood-based markers that may provide a promising alternative or supplement to fecal testing for non-invasive CRC screening. One method under development is to identify aberrantly methylated genes in cancer tissue through a blood test. Prior studies have explored those specific colorectal cancer genes that show the highest differences in methylation between the cancer and background genetic expression. Of these, methylation of the Septin 9 gene through a qPCR assay is relatively well studied. The proposed study aims to evaluate whether the Septin 9 biomarker may be used to supplement the OC-Micro FIT for colorectal cancer screening in such a way as to safely reduce unneeded colonoscopies. The population of interest for this study-those with a positive screening OC-Micro fecal immunochemical test-has a CRC prevalence of approximately 5%. Knowing how well Septin 9 can identify those without cancer prior to colonoscopy is important largely because colonoscopy, even when done diagnostically (e.g., after a positive FIT result), can cause serious complications.

Differences in 30-year Trends in Incidence and Survival for Malignant Germ Cell Tumors in Males and Females.

Tectal plate gliomas are relatively rare tumors of childhood with a reported incidence of 10%. Their typical clinical presentation is symptoms and signs of hydrocephalus and are often incidentally diagnosed in the imaging work-up of children with hydrocephalus. Tectal tumors in children comprise a subcategory of brainstem tumors with unique clinical, imaging, and spectroscopic features. There is debate whether they truly represent brainstem tumors or whether they are a site of benign cellular overgrowth. The majority of these tumors are pathologically benign and show no or minimal growth. Not all tectal plate tumors, however, have this typically benign course. Some can manifest a more aggressive behavior. There have been reports in the past attempting to analyze the histology and behavior of these tumors. None of the prior series looking at these tumors have included Magnetic Resonance Spectroscopy (MRS) analysis. It is interesting that according to where tumors occur in the brainstem usually indicates what their histology and behavior is. Although not absolute, we know that tumors can have a very poor prognosis versus an extremely good prognosis depending on their location in the brainstem. Yet there are always the cases that do not act in the typical fashion and this is where MRS can prove helpful. This study is being done to look at a region of the brain, called the tectal plate, in children. This part of the brain can be involved by tumors. Because of the location of the tectal plate, it is usually very difficult and risky to get a biopsy (tissue sample) from this area. Magnetic Resonance Spectroscopy (MRS) is a non-invasive imaging technique that can look at the chemical make up of the brain. MRS may allow us to better understand the nature and behavior of these tumors. However, in order to understand disease in this area, we need to look at the normal chemical make up of the brain in children without tectal plate tumors. Healthy patients are being asked to participate as a normal volunteer. We anticipate having a total of 10 to 12 normal volunteers in the MRS study.

Single patient expanded access program to provide galinpepimut-S for eligible patients with AML or MDS who have no other treatment option.

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-400 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

This is an open label, multi-center expanded access treatment protocol evaluating lifileucel (LN-144) in patients with unresectable or metastatic melanoma.

This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials.

To provide elotuzumab treatment for single-patient use.

This is an expanded access study with ANG1005 treatment for two individual patients from Protocol ANG1005-CLN-03 with WHO Grade III Anaplastic Astrocytoma and WHO Grade III Anaplastic Oligodendroglioma and one individual patient from Protocol ANG1005-CLN-04 with Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.

This is a single arm open label, multicenter, non randomized, access study of trametinib for subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV). Trametinib may be given as monotherapy or in combination since first line metastatic melanoma as per inclusion criteria. Subjects who received prior BRAF inhibitor may be included if they have not progressed under such treatment or if they have presented limited progression as per eligibility criteria. It is estimated that between 250 and 400 subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV) will be enrolled.