Active clinical trials for "Breast Neoplasms"

Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death among females world wide. breast cancer alone accounts for 25% of all cancer cases and 15% of all cancer deaths among females.

This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.

Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes.

The two main objectives of this prospective study are: to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1), to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2). The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer . This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.

Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. It may also provide information on tumor markers (hormone receptors, HER2) that can guide treatment decisions. The goal of this study is to determine whether blood tests (which require less-invasive procedures) can be used to confirm diagnosis of suspected recurrent breast cancer (as compared to tissue biopsy). Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood), circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood), as well as other biomarkers. Investigators will conduct this study in 120 participants who present with suspected breast cancer recurrence and symptoms of cancer that has spread to other areas in the body. Participants will be asked for blood collection within 30 days before tissue biopsy. The tissue will be analysed locally to determine the presence of cancer and the tumor markers listed above. The blood will be processed and stored for analysis of CTCs and ctDNA. If these blood tests show concordance with tissue based tests (presence of cancer cells, hormone receptors & HER2 status), these tests could be used in future studies to confirm diagnosis using a non-invasive procedure. Also, investigators believe that the results of this study can influence other research of early-stage recurrent breast cancer.

A population-based case-cohort study of breast cancer-specific survival among all first invasive breast cancer cases

Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.

Octava has two versions, each with a different intend of use. OctavaPink is a qualitative in vitro diagnostic test service, performed by authorized clinical laboratories. The product is used for two following indications: Intend of Use #1: OctavaPink is indicated for women above 18 years old, who performed mammography and were determined negative for breast cancer. Being moderately sensitive (>55% sensitivity) the test is able to detect 55% of mammography false negatives. In addition, being highly specific (>95% specificity) it supplies additional evidence for true mammography negative result which will reduce examinees anxiety of being misdiagnosed as a result of high false negative mammography rate (10-30%) Intend of Use #2: OctavaPink is indicated for women above 18 years old, who performed biopsy after positive mammography and the biopsy result was negative. Being moderately sensitive (>55% sensitivity) the test is able to detect 55% of biopsy false negatives. In addition being highly specific (>95% specificity) it supplies an additional evidence for true biopsy negative result which reduces examinees anxiety of being misdiagnosed. OctavBlue is a qualitative in vitro diagnostic test service, performed by EventusDx authorized laboratories. Intend of use of OctavBlue is the following: • OctavBlue is indicated for women above 18 years old, who performed mammography and received doubtful results. Being highly sensitive (>95% sensitivity) the test can help to reveal 95% of positive cases; and being moderately specific (>55% specificity) - about half of negative cases. The test is not intended to be used as a standalone diagnostic technique but to supply additional information to a physician and help deciding about the further course of diagnosis.

The purpose of this study is to evaluate the use of advanced quantitative mass spectometry (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor and to compare the protein profile between different subtypes of breast cancer (ER positive, HER2 positive, triple negative). A maximum of 100 breast tumor specimens will be obtained from the NUHS Tissue repository, comprising approximately equal proportion of ER positive, HER2 positive, and triple negative tumors. Samples will be analyzed using advanced Mass Spectrometry (Super SILAC) as a discovery platform to identify novel protein biomarkers that may be important in cancer. DNA and RNA will also be extracted from tumor samples for correlative analysis with the proteomics data. Genomics and proteomics data will be correlated with clinical data including treatment response and survival data. Importance of proposed research to science or medicine:Identification of tumor biomarkers may allow better prognostication, follow-up, and selection of treatment for cancer patients in the future. Potential benefits and risks: No direct benefit to the patient. Risk to the subjects is minimal as there is no direct patient contact, and analysis is done on previously donated tumor samples. Patients have previously provided consent to donate their samples for research into the NUHS Tissue Repository. Novel tumor biomarkers that determine tumor biology, including prognosis and treatment sensitivity, may be detectable using the novel advanced quantitative mass spectromy method (Super SILAC). Different subtypes of breast cancers will have different proteomic profiles analyzed using super SILAC.

The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. The biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.