Phase 2 Clinical Trial of Randomized, Blinded, Positive-controlled to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.

This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old.
In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis.
In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old.

开始日期2023-07-18

申办/合作机构

成都可恩生物科技有限公司

[+2]

NCT06224608

/ Completed临床1期

Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis

The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis patients, with 20 participants in each dosage group. Within 28 days after the skin test of the test drug, observations were made of reactions at the skin test site, reactions at non-skin test sites, concomitant medication, and any other physical discomfort (skin test site-specific reactions were recorded separately).

开始日期2023-01-17

申办/合作机构

成都可恩生物科技有限公司

[+1]

CTR20250169

/ Not yet recruiting临床3期

评价EEC在3岁及以上人群中用于结核杆菌感染诊断的有效性和安全性的III期临床试验

用于结核杆菌感染诊断，皮试结果不受卡介苗（BCG）接种的影响，可用于辅助结核病的临床诊断

开始日期-

申办/合作机构

成都可恩生物科技有限公司

100 项与重组结核杆菌融合蛋白（EEC）（成都可恩生物科技）相关的临床结果

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100 项与重组结核杆菌融合蛋白（EEC）（成都可恩生物科技）相关的转化医学

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100 项与重组结核杆菌融合蛋白（EEC）（成都可恩生物科技）相关的专利（医药）

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279

项与重组结核杆菌融合蛋白（EEC）（成都可恩生物科技）相关的文献（医药）

2025-09-01·EUROPEAN JOURNAL OF RADIOLOGY

Magnetic resonance imaging features of mesonephric-like adenocarcinoma of the uterine corpus in comparison with endometrial endometrioid carcinoma: Multi-institutional study

Article

作者: Yamada, Kaori ; Masuoka, Sota ; Fujiwara, Hiroyuki ; Fujii, Shinya ; Matsuki, Mitsuru ; Fukushima, Noriyoshi ; Fukui, Hideyuki ; Yamamoto, Saki ; Mori, Harushi ; Kato, Hiroki ; Fujii, Hiroyuki ; Himoto, Yuki ; Ueno, Yoshiko ; Tsuboyama, Takahiro ; Sano, Naoki ; Kihara, Atsushi ; Kikuchi, Tomohiro

PURPOSE:

To examine magnetic resonance imaging (MRI) features of mesonephric-like adenocarcinoma (MLA) of the uterine corpus.

METHOD:

MRI features of 19 patients with pathologically proven MLA of the uterine corpus were retrospectively compared with those of 95 patients with endometrial endometrioid carcinoma (EEC).

RESULTS:

Most patients with MLA were postmenopausal. Advanced FIGO stages were more common in the MLA than in the EEC group (63.2 % vs. 18.9 %, p < 0.001). On MRI, endophytic growth into the myometrium were more frequent in the MLA than in the EEC group (68.4 % vs. 14.7 %, p = 0.005). The median maximum tumor diameter in the MLA group (52.4 mm) tended to be larger than that in the EEC group (38.9 mm), although the difference was not statistically significant (p = 0.374). The tumor-to-muscle signal intensity ratio (SIR) on fat-suppressed gadolinium-enhanced T1-weighted gradient-echo imaging was higher in the MLA group than in the EEC group. (1.67 vs. 1.36, p = 0.002). The SIR on diffusion-weighted imaging (DWI) was comparable between the two groups (8.35 vs. 6.72, p = 0.330). The apparent diffusion coefficient value was lower in the MLA than in the EEC group (0.69 10^-3 mm²/s vs. 0.76 × 10^-3 mm²/s, p = 0.003). Coexisting adenomyosis was more frequent in the MLA than in the EEC group (52.6 % vs. 21.1 %, p = 0.034). The concordance rate between MRI and pathology for adenomyosis coexistence was 84.2 % for MLA, 87.4 % for EEC, and 86.8 % overall. MLA of the uterine corpus was identified in two patients, characterized by development independent of and discontinuous from the endometrium, whereas EEC in all patients demonstrated continuity with the endometrium.

CONCLUSIONS:

MRI of MLA of the uterine corpus typically demonstrates large, diffuse, and endophytic growth into the myometrium, with strong contrast enhancement and more restricted diffusion compared to EEC, with coexisting adenomyosis present in over 50% of patients. Therefore, postmenopausal women with adenomyosis should be carefully evaluated for MLA on MRI, particularly using DWI.

2025-06-01·PATHOLOGY

Digital image analysis of gland-to-stroma ratio by CD10 objectively differentiates between low-grade endometrioid carcinoma and atypical hyperplasia on endometrial biopsy

Article

作者: Ho, Johnny Y Y ; Ip, Philip P C ; Lee, Jacqueline H S ; Yeung, Carol S Y ; Ng, Joanna K M ; Lee, Conrad H C ; Li, Joshua J X

Distinguishing between endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (EAH/EIN) and grade 1 endometrial endometrioid carcinoma (EEC) requires the evaluation of gland-to-stromal ratio, presence of stromal invasion, extent of epithelial proliferation and nuclear alterations. In small biopsies, stromal invasion may not always be sampled, so other features become more important. However, assessing of some of these features may be subjective. Digital analysis improves diagnostic uniformity, and when combined with CD10 immunostain, it can potentially become a useful objective parameter. Endometrial biopsies with a diagnosis of EAH/EIN or EEC matched were retrieved with subsequent hysterectomy for reference diagnosis. CD10 immunohistochemistry was applied to the biopsies, followed by scanning and annotation. Pixel-accurate stromal percentages were deduced from digitised whole-slide images from a test cohort. An optimal stromal percentage cut-off, thus gland-to-stroma ratio, was extrapolated from the receiver operating characteristic curve. A separate cohort was used to validate the diagnostic performance of the determined gland-to-stroma cut-off. Seventy endometrial biopsies were included in the test cohort, comprising 48 grade 1 EECs and 22 EAH/EINs. The mean stromal percentage was 15.69% for EEC and 33.65% for EAH/EIN (all endometrial tissue annotated/analysed) and 14.77% for EEC and 31.88% for EAH/EIN (only lesional tissue annotated/analysed). The corresponding gland-to-stroma ratio was 5:1 for EEC and 2:1 for EAH/EIN. The areas under curve were 0.758 (p=0.001) (all endometrial tissue) and 0.761 (p=0.001) (only lesional tissue), (p=0.001). In the validation cohort, a cut-off of 30% CD10-stained stroma (7:3 gland-to-stroma ratio) was superior in diagnostic performance than the H&E diagnosis (p=0.042). Evaluation of gland-to-stroma ratio using CD10 immunostain and digital image analysis is a robust and objective method for distinguishing between grade 1 EEC and EAH/EIN in small biopsies. A cut-off >7:3 is highly indicative of EEC.

2025-03-03·JNCI Cancer Spectrum

Easy ensemble classifier-group and intersectional fairness and threshold (EEC-GIFT): a fairness-aware machine learning framework for lung cancer screening eligibility using real-world data

Article

作者: Green, Lee ; Schabath, Matthew B ; Luo, Yi ; Valdes, Gilmer ; Le, Trung ; Byrne, Margaret M ; Robinson, Lary A ; El Naqa, Issam ; Conahan, Piyawan

Abstract:

Background:

We use real-world data to develop a lung cancer screening (LCS) eligibility mechanism that is both accurate and free from racial bias.

Methods:

Our data came from the Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial. We built a systematic fairness-aware machine learning framework by integrating a Group and Intersectional Fairness and Threshold (GIFT) strategy with an easy ensemble classifier—(EEC-) or logistic regression—(LR-) based model. The best LCS eligibility mechanism EEC-GIFT* and LR-GIFT* were applied to the testing dataset and their performances were compared to the 2021 US Preventive Services Task Force (USPSTF) criteria and PLCOM2012 model. The equal opportunity difference (EOD) of developing lung cancer between Black and White smokers was used to evaluate mechanism fairness.

Results:

The fairness of LR-GIFT* or EEC-GIFT* during training was notably greater than that of the LR or EEC models without greatly reducing their accuracy. During testing, the EEC-GIFT* (85.16% vs 78.08%, P < .001) and LR-GIFT* (85.98% vs 78.08%, P < .001) models significantly improved sensitivity without sacrificing specificity compared to the 2021 USPSTF criteria. The EEC-GIFT* (0.785 vs 0.788, P = .28) and LR-GIFT* (0.785 vs 0.788, P = .30) showed similar area under receiver operating characteristic curve values compared to the PLCOM2012 model. While the average EODs between Blacks and Whites were significant for the 2021 USPSTF criteria (0.0673, P < .001), PLCOM2012 (0.0566, P < .001), and LR-GIFT* (0.0081, P < .001), the EEC-GIFT* model was unbiased (0.0034, P = .07).

Conclusion:

Our EEC-GIFT* LCS eligibility mechanism can significantly mitigate racial biases in eligibility determination without compromising its predictive performance.

100 项与重组结核杆菌融合蛋白（EEC）（成都可恩生物科技）相关的药物交易

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