Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Body Weight

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Control group (n=30) comprising surgical candidates with normal endometrial tissue will be collected for comparison.

1. 1st year: 50 eligible patients surgical candidates of endometrial cancer with pre-operative imaging and biological samples collected during operation.
2. 2nd year: Enroll another 50 surgical candidates and complete the data regarding clinical MRS/diffusion-weighted imaging and tissue high resolution MRS. Together with the 50 cancer subjects in the first year there will be in total 100 cancer subjects for analysis.
3. 3rd year: Collect enough positive events with any myometrial involvement (n=30), cervical stromal invasion (n=10) and nodal metastasis (n=10). Together with the 100 cancer subjects in the first and second years there will be in total 150 cancer subjects for analysis.

Gigin Lin, MD, PhD

The aims of this project are: (1) To establish a research platform in order to integrate multiparametric imaging and metabolomics data for uterine malignancy. (2) Identify potential surrogate biomarkers for early diagnosis of endometrial cancer by using multiparametric magnetic resonance imaging and metabolomics approach. (3) To develop surrogate biomarkers for uterine malignancy, in detecting tumor involvement of myometrium, cervix, and lymph nodes. The investigators propose a 3-year research project to prospectively collect data from 150 female patients 20-80 years old, with clinically diagnosed or suspected to have uterine malignancy. An additional control group comprising 30 patients with normal endometrial tissue will be enrolled. Robust magnetic resonance (MR) imaging techniques including MR spectroscopy (MRS), diffusion-weighted imaging and chemical exchange saturation transfer (CEST) imaging will be applied. Biological samples (tissue, blood, urine) will be analyzed by detailed metabolomics approach (high-resolution MRS).

In the 1st year part of this project, the investigators aim to identify the differences between normal endometrium and cancer tissue. Standard conventional MR study plus MRS, diffusion-weighted imaging and CEST sequences will be carried out on 30 eligible surgical candidates for pretreatment clinical assessment.Metabolites in cancer tissue will be collected during operation and analyzed using high resolution MRS, and compared with control group. The primary endpoint of this part is to identify different imaging and metabolomic profiles between normal and cancer subjects. In the 2nd year, the investigators will continue accumulate case number, in order to evaluate the diagnostic accuracy of advanced MR imaging and metabolomics biomarker, in prediction of T staging and myometrial involvement. By the end of 3rd year, the investigators will collect 150 patients, with approximately 20 cases with cervical invasion and 20 cases with nodal metastasis, in order to answer how this approach predicts cervical stromal involvement, nodal and distant metastasis.

The clinical importance of this project is answer the most relevant questions, i.e., prediction of tumor involvement of myometrium, cervix, and lymph nodes. This will be important for understanding the background mechanism of changes identified by MR and 18-F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) /PET, in order to develop novel imaging biomarkers or therapeutic targets. Both molecular imaging and metabolomics are complimentary and share similarities: (1) Comprehensive data representing the information of the living system as a whole (2) information rich data which reflecting the complexity of the biological system (3) ease for longitudinal observation. Metabolomics data provides more details on biochemistry whilst imaging data provides more spatial localization details. A combination of imaging and metabolomics approach would be an ideal tool to develop biomarkers for uterine malignancy. By completion of this project, the investigators expect the most important metabolic biomarkers will be established, and potentially serve as functional tools to guide therapy for patient with uterine malignancy.

1. Plasma sample preparation for global metabolites analysis and lipidomic analysis:
2. Urine samples will be diluted with distilled water. Samples are centrifuged at 14,000 g for 5 min, and the supernatants will be collected for LC-MS analysis.
3. Cellular metabolites extraction: Extraction method will be carried out by the method modified by Munger and Patterson. The medium will be aspirated from culture plates containing cells and 80% methanol (at -80°C) will immediately be added.

MRI and Metabolomics Biomarkers for Uterine Malignancy

Multiparametric Magnetic Resonance Imaging and Metabolomics Approaches to Study Biomarkers for Uterine Malignancy

Chang Gung Memorial Hospital

Department of Radiology

Carcinoma

Adenocarcinoma

Endometrial Neoplasms

Sherif A Shazly, M.Sc

Esraa M Hosny

This project aims to determining prognostic factors and individualizing management decision per patient characteristics and endometrial cancer features. This study will include at least 10 centers from different countries that present at least Europe, South America, Asia, and Africa. Data will be retrospectively collected from January 2008 to December 2015 with a total follow-up of at least 5 years (December 2020).

Endometrial cancer (EC) or carcinoma of corpus uteri is a neoplastic change, mostly adenocarcinoma, arising from uterine columnar epithelial lining. Abnormal uterine bleeding is the main presenting symptom especially in postmenopausal women. EC is estimated to be the seventh most commonly diagnosed cancer in women. It is considered the 16th leading cause of death in women with cancer worldwide, with 382 000 estimated new cases and 89 900 deaths in 2018. Factors as obesity, parity, diabetes mellitus, unopposed estrogen exposure, genetics and hormonal therapies are recognizable risks for EC. Other factors as chronic comorbidities, tumor size and organ metastasis influence staging, prognosis, and management protocols.

FIGO staging has been adopted as the standard classification system in the management of endometrial cancer. However, this staging system does not consider all factors that affect treatment decision and prognosis including but not limited to patient demographics, tumor grade, and lymphovascular space invasion. In addition, some interventions are still debatable particularly in the presence of intermediate disease e.g, grade II early EC. Available evidence supports combined pelvic and para-aortic lymphadenectomy in management of patients with EC. However, combined pelvic and para-aortic lymphadenectomy carry the risk of long term morbidities as lymphedema. Thus, hysterectomy alone as management plan is suggested in patients with low risk EC. More comprehensive studies of the multiple confounders that determine patient's risk are essential to reach an individually adjusted management plans and to predict prognosis of each individual case. Therefore, availability of large multicenter studies will provide robust evidence regarding optimal management of EC and hence, improve treatment outcome and prognosis particularly in the era of machine learning and artificial intelligence.

Endometrial Cancer International Database

Endometrial Cancer, a New Prospective Towards an Individually Adjusted Management Plans: A Multicenter International Study

Number of women who are alive after cancer treatment divided by total number of patients at study onset

Number of women who are are disease free after cancer treatment divided by total number of patients at study onset

Study title	NCT ID	Conditions	Eligibility	Organization
MRI and Metabolomics Biomarkers for Uterine Malignancy	NCT02528864	Uterine Neoplas...	20 Years - 80 Years	Chang Gung Memorial Hospital
MRI and Metabolomics Biomarkers for Uterine Malignancy	NCT02528864	Uterine Neoplas...	20 Years - 80 Years	Chang Gung Memorial Hospital
Endometrial Cancer International Database	NCT04787159	Endometrial Can...	18 Years - 75 Years	Assiut University
Endometrial Cancer International Database	NCT04787159	Endometrial Can...	18 Years - 75 Years	Assiut University
Endometrial Cancer International Database	NCT04787159	Endometrial Can...	18 Years - 75 Years	Assiut University

Spots Global Cancer Trial Database for uterine malignancy