Efficacy, Safety, Cosmesis and Patient Satisfaction With Vacuum-Assisted Percutaneous Excision (VAPE) Compared With Standard Surgical Excision (X) of Non-malignant, Borderline or High-risk Breast Lesions: A Randomized Controlled Trial

This randomized controlled trial compares vacuum-assisted percutaneous excision to open standard surgical excision in women who have high-risk or borderline, non-malignant breast lesions with respect to efficacy, safety, cosmesis and patient satisfaction.

开始日期2025-01-01

申办/合作机构

Lawson Health Research Institute

NCT06073184 / Not yet recruiting临床2期IIT

Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium (WE-FiERCE)

The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.

开始日期2024-09-01

申办/合作机构

University Health Network

NCT05941520 / Recruiting临床2期IIT

Phase IIA Trial of Acolbifene (20 mg) vs Low Dose Tamoxifen (5 mg) in Pre-Menopausal Women at High Risk for Development of Breast Cancer

This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging (MRI) or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.

开始日期2024-08-23

申办/合作机构

National Cancer Institute

100 项与非典型增生相关的临床结果

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100 项与非典型增生相关的转化医学

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0 项与非典型增生相关的专利（医药）

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项与非典型增生相关的文献（医药）

2024-12-01·European Journal of Radiology Open

CT-based radiomics combined with clinical features for invasiveness prediction and pathological subtypes classification of subsolid pulmonary nodules

Article

作者: Pan, Aizhen ; Duan, Rui ; Li, Zhiheng ; Lin, Yan ; Fu, Zijie ; Liu, Miaozhi ; Xu, Zhifeng

PurposeTo construct optimal models for predicting the invasiveness and pathological subtypes of subsolid nodules (SSNs) based on CT radiomics and clinical features.Materials and MethodsThis study was a retrospective study involving two centers. A total of 316 patients with 353 SSNs confirmed as atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA) and invasive adenocarcinoma (IAC) were included from January 2019 to February 2023. Models based on CT radiomics and clinical features were constructed for classification of AAH/AIS and MIA, MIA and IAC, as well as lepidic-predominant adenocarcinoma (LPA) and acinar-predominant adenocarcinoma (APA). Receiver operating characteristic (ROC) curve was used to evaluate the model performance. Finally, the nomograms based on the optimal models were established.ResultsThe nomogram based on the combined model (AAH/AIS versus MIA) consisting of lobulation, the GGN-vessel relationship, diameter, CT value, consolidation tumor ratio (CTR) and rad-score performed the best (AUC=0.841), while age, CT value, CTR and rad-score were the significant features for distinguishing MIA from IAC, the nomogram based on these features performed the best (AUC=0.878). There were no significant differences in clinical features between LPA and APA, while the radiomics model based on rad-score showed good performance for distinguishing LPA from APA (AUC=0.926).ConclusionsThe nomograms based on radiomics and clinical features could predict the invasiveness of SSNs accurately. Moreover, radiomics models showed good performance in distinguishing LPA from APA.

2024-12-01·The Breast

Atypical ductal or lobular hyperplasia, lobular carcinoma in-situ, flat epithelial atypia, and future risk of developing breast cancer: Systematic review and meta-analysis

Review

作者: Sprague, Brian L. ; Salisbury, Elizabeth ; Baker, Jannah ; Marinovich, M Luke ; Noguchi, Naomi ; Houssami, Nehmat ; Sprague, Brian L

BACKGROUNDBiopsy-proven breast lesions such as atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS) and flat epithelial atypia (FEA) increase subsequent risk of breast cancer (BC), but long-term risk has not been synthesized. A systematic review was conducted to quantify future risk of breast cancer accounting for time since diagnosis of these high-risk lesions.METHODSA systematic search of literature from 2000 was performed to identify studies reporting BC as an outcome following core-needle or excision biopsy histology diagnosis of ADH, ALH, LCIS, lobular neoplasia (LN) or FEA. Meta-analyses were conducted to estimate cumulative BC incidence at five-yearly intervals following initial diagnosis for each histology type.RESULTSSeventy studies reporting on 47,671 subjects met eligibility criteria. BC incidence at five years post-diagnosis with a high-risk lesion was estimated to be 9.3 % (95 % CI 6.9-12.5 %) for LCIS, 6.6 % (95 % CI 4.4-9.7 %) for ADH, 9.7 % (95 % CI 5.3-17.2 %) for ALH, 8.6 % (95 % CI 6.5-11.4 %) for LN, and 3.8 % (95 % CI 1.2-11.7 %) for FEA. At ten years post-diagnosis, BC incidence was estimated to be 11.8 % (95 % CI 9.0-15.3 %) for LCIS, 13.9 % (95 % CI 7.8-23.6 %) for ADH, 15.4 % (95 % CI 7.2-29.3 %) for ALH, 17.0 % (95 % CI 7.2-35.3 %) for LN and 7.2 % (95 % CI 2.2-21.2 %) for FEA.CONCLUSIONOur findings demonstrate increased BC risk sustained over time since initial diagnosis of high-risk breast lesions, varying by lesion type, with relatively less evidence for FEA.

2024-12-01·European Journal of Radiology

Radiomic and clinical model for predicting atypical ductal hyperplasia upgrades and potentially reduce unnecessary surgical treatments

Article

作者: Cesano, Sara ; Campi, Cristina ; Starovatskyi, Oleksandr ; Bozzano, Silvia ; Brunetti, Nicole ; Biddau, Giorgia ; Stefano Tagliafico, Alberto ; Garlaschi, Alessandro ; Tosto, Simona ; Conti, Benedetta ; Piana, Michele ; Calabrese, Massimo ; Picone, Ilaria ; Rescinito, Giuseppe

OBJECTIVETo identify patients with atypical ductal hyperplasia (ADH) at low risk of upgrading to carcinoma. This study aims to assess the performance of radiomics combined with clinical factors to predict occult breast cancer among women diagnosed with ADH.METHODSThis study retrospectively included microcalcification clusters of patients who underwent Mx and VABB with a diagnosis of ADH at a tertiary center from January 2015 to May 2023. Clinical and radiological data (age, cluster size, BI-RADS classification, mammographic density, breast cancer history, residual microcalcifications) were collected. Surgical outcomes were used to determine upgrade. Four logistic regression models were developed to predict the risk of upgrade. The performance was evaluated using the area under the receiver operating characteristic curve (AUC) and performance scores.RESULTSA total of 143 patients with 153 clusters were included. Twelve radiomic features and six clinical factors were selected for model development. The sample was split into 107 training and 46 test cases. Clinical features achieved an AUC of 0.72 (0.60-0.84), radiomic features an AUC of 0.73 (0.61-0.85). Radiomic features with "cluster size" and "age" improved the AUC to 0.79 (0.67-0.91). The best model, incorporating all data, achieved an AUC of 0.82 (0.71-0.92), a specificity of 0.89 (0.75, 0.97), and NPV of 0.92 (0.78-0.98).CONCLUSIONThis study demonstrates the potential of radiomic as a valuable tool for reducing unnecessary treatments for patient classified as "low risk of ADH upgrade". Combining radiomic information with clinical data improved the accuracy of risk prediction.