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Breast Cancer clinical trials

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NCT ID: NCT05650086 Suspended - Breast Cancer Clinical Trials

Novel Thermal Imaging Technique for Breast Screening

Start date: November 15, 2022
Study type: Observational

This trial is to study a new breast imaging tool called Thermalytixâ„¢. ThermalytixTM is a new radiation-free, automated breast cancer screening technique that uses Artificial Intelligence (AI) over thermal images. Thermal images are heat signatures in our body. This new technique will capture heat signatures in the breast and analyze those images with AI software. This study will evaluate the performance of ThermalytixTM breast imaging against standard imaging modalities, such as mammography and ultrasound.

NCT ID: NCT05506800 Suspended - Breast Cancer Clinical Trials

Guangzhou Women's Health Cohort Study (GWHCS)

Start date: March 3, 2016
Study type: Observational

The Guangzhou Women's Health Cohort Study aims to explore the health trajectory and factors contributing to the health of women aged 35-64 in Guangzhou. Based on multiple population health registration data platforms, data of the cohort will provide information about the health of women across the lifespan, facilitating the decision-making process by local government . The cohort is progressing steadily, and the goal is to build a large women cohort covering 11 administrative districts of Guangzhou with a scale of 1 million by 2030.

NCT ID: NCT05370300 Suspended - Breast Cancer Clinical Trials

SNAPS Breast Cancer Patient Study Breast Cancer Patients

Start date: September 1, 2024
Study type: Observational

Differential immunogenomic signatures from peripheral blood CD14 (phagocytic) and CD2 (non-phagocytic) cells have been associated with multiple cancers and disease states. In particular several large clinical studies at Immunis.AI have demonstrated robust immunogenomic signatures in early-stage prostate cancer. Immunis.AI therefore hypothesizes that a peripheral blood immunogenomic signature will identify patients with various stages of breast cancer from healthy negative controls.

NCT ID: NCT05000294 Suspended - Breast Cancer Clinical Trials

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Start date: November 3, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.

NCT ID: NCT04973930 Suspended - Breast Cancer Clinical Trials

Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer

Start date: March 1, 2022
Phase: Phase 3
Study type: Interventional

Cancer and depression commonly occur together, and each worsens the other. We conducted a large psychotherapy study treating depression in breast cancer patients, showing that psychotherapy lowers symptoms. Surprisingly, no studies have compared depression-focused psychotherapy to antidepressant medication for patients with breast cancer and depression. We applied to the National Cancer Institute for a large, cross-national grant. Reviewers asked us to first demonstrate that patients would accept either psychotherapy or medication as treatment. Thanks to funding from the Columbia Herbert Irving Cancer Center, we will test this study approach. We will randomly assign 20 patients with both non-metastatic breast cancer and major depression to 12 weeks of tele-therapy (by Zoom) with either interpersonal psychotherapy or a serotonin reuptake inhibitor. We expect patients in both treatments to report improvement in depression symptoms. We will also measure C-reactive protein, a blood test of inflammation elevated in both cancer and depression, which may predict medication response.

NCT ID: NCT04683120 Suspended - Breast Cancer Clinical Trials

Real-time Diagnosis and Visualization of Tumor Margins in Excised Breast Specimens Using Zenith FLIM Diagnostics

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

Our investigational team has developed a technology to visualize the operative margins in 'real time,' in other words during the operation while the patient is still on the table. While different surgeons use different operative techniques, our technique involves removing the main lumpectomy specimen, marking two of its borders with suture to orient the specimen for correct pathologic evaluation. The FLIM (Fluorescent Lifetime Imaging Microscopy) technique can differentiate between cancerous and noncancerous specimens using a complex algorithm that essentially utilizes a definitive delta between the metabolic activities of diseased and non-diseased tissue. The research coordinator along with the surgeon will be able to insert the lumpectomy specimen followed by the 6 shaved margins (one by one) in a matter of minutes once the specimens have been resected. To be clear, the FLIM analysis will be taking place in- vitro. The device is invitro test and would be tested against the gold standard the pathologist biopsy. FLIM analysis by the surgeon will not take more than several minutes, therefore not adding any significant time for patient to be under anesthesia. All specimens will be removed from the patient's body prior to their evaluation by the FLIM technique. Our team will not be making decisions based on FLIM analysis during this early phase of study. In other words, even if FLIM suggests a positive margin still exists in the body, our team will not act on these results by resecting additional tissue at this stage. FLIM margin results will be compared directly with pathology results for accuracy of the findings.

NCT ID: NCT04474652 Suspended - Breast Cancer Clinical Trials

Guide for Prioritisation of Patients for Referral to Breast Clinics

Start date: February 12, 2020
Study type: Observational

GPs in primary care in England currently refer over 2.17 million patients per year with vague symptoms to the urgent cancer referral pathway. While this catches over 150,000 cancer cases each year, 93% of the referred patients do not have cancer. For breast cancer, GPs refer 343,000 cases per year. Each of these patients are referred to a one stop clinic for diagnosis. The Leeds teaching Hospitals' Trusts' Breast Unit, receives 10,000 per year, with only 5% of patients actually being diagnosed with cancer. The breast cancer pathway involves a triple assessment process, which includes a clinical examination, imaging (mammogram or ultrasound) and possibly a biopsy test. It is a particularly expensive process as it is an imagingintense pathway; this places considerable strain on NHS diagnostic facilities. Small changes will not be enough to solve this problem - a new approach is needed. The purpose of this study is to see if we can develop a blood test that can support doctors in identifying patients for whom the likelihood of having breast cancer is extremely low. This would avoid unnecessary referral for those patients to the one stop clinic. Patients with higher chances of suspected breast cancer would be referred to the one stop clinic in the usual way. Key to the idea of safely "ruling-out" patients is that the test must not miss patients who do have cancer. By measuring a broad range of indicators (markers) in blood, the test will provide a more accurate picture of the underlying biology. The test is also being developed within the NHS, so that it can be adopted quickly into NHS computer systems and laboratories to maximise patient benefit, whilst being held to the NHS's high standards for clinical evidence and value.

NCT ID: NCT04339517 Suspended - Breast Cancer Clinical Trials

Postoperative Identification of Tumor Cells at the Lumpectomy Site of Patients With Early Breast Cancer

Start date: August 17, 2021
Phase: N/A
Study type: Interventional

For early breast cancer, local surgery followed by breast radiation is a standard local treatment. It has been found that the original primary tumor site, the lumpectomy site, is the commonest location of local relapse. The researchers think that such relapse occurs because of persistent tumor cells (PTCs) at the lumpectomy site even when conventional pathology reports indicate complete resection with clear margins. The researchers propose to analyze the lumpectomy fluid (seroma) of patients who are one to six weeks post-surgery for the presence or absence of tumor cells using new technology. Results of this study may help identify women who may have increased local relapse risk beyond that suggested by conventional pathology and clinical features; it may also help identify women at very low risk of local relapse who could avoid any additional treatment after local surgery.

NCT ID: NCT04151368 Suspended - Breast Cancer Clinical Trials

Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Nipple-sparing mastectomy (NSM) with immediate reconstruction is one of the standard of care surgical treatments of breast cancer (BC) and is used for risk reduction in patients with a high risk for BC. While this method shows satisfactory oncologic and good cosmetic outcomes, its drawbacks include compromise of the skin flap vascularization due to skin incision, nipple-areolar complex (NAC) malposition/distortion and visible scar on the breast. NSM also has technical challenges of dissecting and removing larger specimens through limited incisions and concerns regarding oncologic effectiveness due to difficulties in visualizing regions of the breast remote from the incision. To improve cosmetic outcomes after NSM, a modification of this technique using a surgical robotic system was recently described. In a limited number of studies, the robotic NSM (RNSM) with immediate prosthetic breast reconstruction (IPBR) was shown to be feasible and safe, as well as led to excellent cosmetic outcomes and patient satisfaction. There are limited number of centers in North America and none in Canada that offer RNSM-IPBR. The investigators hypothesize that RNSM-IPBR is a feasible and safe technique that can be utilized in our institution and that it can provide superior cosmetic outcomes with less morbidity and higher patient satisfaction compared to the traditional NSM-IPBR. The aim is to conduct a single-arm prospective study to investigate the safety and feasibility, as well as cosmetic, surgical complication and patient satisfaction parameters of NSM-IPBR performed in the University Health Network (UHN). This study will serve a foundation for potential introduction of a novel surgical approach in our institution and will make it available for treatment and prevention of breast cancer in Canadian women. The study will also serve as pilot data for future potential studies, including randomized-controlled trials (RCT) comparing RNSM with conventional NSM. As such, the study will further our approach to innovation in breast surgical oncology within Canada and North America.

NCT ID: NCT04116281 Suspended - Breast Cancer Clinical Trials

Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery

Start date: December 2, 2019
Phase: N/A
Study type: Interventional

Objectives: To evaluate the pressure pain threshold, shoulder biomechanics, cardiorespiratory function and the quality of life associated with the short and long-term physical therapy rehabilitation following breast cancer surgery. Methodology: The study presents three objectives and involves three groups of participants. Objective 1 is to develop a topographic map of pressure pain in the shoulder (using a digital pressure algometer), evaluate the biomechanics of the shoulder (using a digital inclinometer and load card), cardiorespiratory function (through frequency variability resting heart rate and distance traveled, through the six-minute walk test) and quality of life (through questionnaires of quality of life, anxiety, depression, sleep quality, upper limb functionality, fatigue and level of physical activity) between a group of women prior to the operation of breast cancer (experimental group, n = 36) and a group of asymptomatic controls for shoulder pain (control group, n = 18). Objective 2 is to evaluate the possible changes in the pain map over 24 weeks of supervised kinetic intervention (Supervised Physiotherapy experimental group, n = 18, will begin after drainage, frequency 3 times per week and duration of 60 minutes each session) compared to unsupervised kinetic intervention (Home Physiotherapy experimental group, n = 18, participants will receive an exercise booklet). Objective 3 is to evaluate the biomechanics of the shoulder, cardiorespiratory function and the quality of life with respect to the experimental group with and without kinesic supervision. To achieve objective 1, two baseline evaluations will be carried out in both experimental and control groups (considering the month prior to the surgery of the experimental group) and the average of the evaluations will be considered evaluation 1. To achieve objectives 2 and 3, evaluation 2 (after 4 weeks of intervention), 3 (after 12 weeks of intervention) and 4 (after 24 weeks of intervention) will be performed. The statistical analysis will include the examination of qualitative and quantitative variables. Statistical tests will be applied according to the normality of the data and a significance level of 5% will be adopted for all comparisons. Expected results: It is expected to identify sensory, biomechanical, cardiorespiratory and quality of life alterations in the experimental group, compared to the control group. In addition, after 24 weeks of intervention, the supervised experimental group will show improvement in all the aforementioned variables with respect to the unsupervised group.