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DCIS clinical trials

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NCT ID: NCT06217458 Not yet recruiting - DCIS Clinical Trials

The Added Value of Contrast Enhanced Mammography to Standard Mammography in Assessing the Extent of DCIS

CEMinDCIS
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The study hypothesis is that the rate of inadequate surgical margins after conservative breast surgery for DICS and the rate of reoperation (re-excision or/and mastectomy) is lower in the group of patients who underwent standard preoperative mammography and CEM to assess the extent of DICS, compared to the group of patients for whom the preoperative assessment of the extent of in situ breast cancer was not performed using one of the imaging techniques with contrast medium such as contrast mammography or magnetic resonance imaging.

NCT ID: NCT05912569 Recruiting - DCIS Clinical Trials

Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS

Start date: June 13, 2023
Phase: N/A
Study type: Interventional

In the case of a patient undergoing breast-conserving surgery for intraductal carcinoma, the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery. primary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.

NCT ID: NCT05900986 Recruiting - Breast Cancer Clinical Trials

LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

Start date: July 14, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data.

NCT ID: NCT05868252 Enrolling by invitation - DCIS Clinical Trials

Molecular Analysis of the Sloane Project

Start date: March 1, 2020
Phase:
Study type: Observational

The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. Non invasive breast neoplasia accounts for 25% of all 'breast cancers' detected through breast screening and includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Atypical hyperplasias are high risk but benign lesions found in 10% of benign biopsies performed through the NHS breast screening programme. The importance of these lesions rests on the increased risk of subsequently developing invasive breast cancer, with DCIS at highest risk (20 times greater than the general population) followed by LCIS (10 times greater) and atypical breast hyperplasia (4 times greater). The Sloane Project data are held by Public Health England (PHE) and provide full and detailed information about the patients' journey from diagnosis to treatment and outcome. The project aims to increase the understanding of how best to manage these early lesions which can lead to breast cancer. All NHS breast screening units in the UK are invited to submit data for the Sloane Project. Historically an exceptional ~90% of centres in England, Scotland, Wales and Northern Ireland have participated on a voluntary basis. The objective of this research protocol is the collection of anonymised formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project database in order to allow detailed analysis of the biological, molecular and genomic changes in these cases of in situ carcinoma and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data already collected by and held in PHE. We seek to identify particular signature(s) that define which patients are likely to develop invasive disease, distinguishing the worrisome from indolent, non-worrisome lesions.

NCT ID: NCT05436808 Withdrawn - Breast Cancer Clinical Trials

Partial Chest Wall Radiation Therapy After Surgery for Lymph Node Negative Breast Cancer

Start date: July 15, 2022
Phase: Early Phase 1
Study type: Interventional

The standard treatment for breast cancer when cancer cells were found near or within the margins of the tissue that is removed during breast surgery, is radiation of the entire chest wall. This may be considered overtreatment since the only reason for doing so is that cancer cells were near or in the margins of the breast tissue that was removed. In this study, the amount of radiation treatment will be limited to the area where the remaining cancer cells were found after surgery. The purpose of this study is to find out if partial chest wall radiation therapy is as good as whole chest wall radiation therapy in reducing the risk of breast cancer cancer coming back.

NCT ID: NCT04916808 Recruiting - DCIS Clinical Trials

The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

AUS-PREDICT
Start date: July 2, 2021
Phase:
Study type: Observational [Patient Registry]

This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes that can be queried to determine the utility of the DCISionRT™ test in the diagnosis and treatment of ductal carcinoma in situ of the breast.

NCT ID: NCT04797299 Recruiting - DCIS Clinical Trials

Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

ELISA
Start date: November 23, 2022
Phase:
Study type: Observational

To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)

NCT ID: NCT04722692 Recruiting - Breast Cancer Clinical Trials

Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

SENTINOT_2
Start date: March 1, 2020
Phase: Phase 3
Study type: Interventional

The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed.

NCT ID: NCT04245150 Active, not recruiting - Clinical trials for Invasive Breast Cancer

Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

Start date: March 21, 2019
Phase:
Study type: Observational

Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.

NCT ID: NCT04170920 Completed - Breast Cancer Clinical Trials

Pilot Study of a an App to Improve Medication Adherence in Breast Cancer Survivors Receiving AIs

Start date: February 17, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility of an mobile-health strategy to improve patient-reported symptoms, promote life-saving medication adherence, and encourage healthy lifestyle behaviors in early stage breast cancer survivors receiving adjuvant Aromatase inhibitors, while beginning to predict psycho-social and demographic characteristics of those who benefit most from this approach. This will provide preliminary experience and evidence for larger, randomized clinical trials evaluating this methodology, which will have immediate and scalable influence on cancer survivor ship.