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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05251883
Other study ID # SYSEC-KY-KS-2021-215
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 2026

Study information

Verified date September 2022
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Huaiwu Lu, Study Director
Phone +86 18688395806
Email luhuaiwu@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

As one of the most common malignant tumors in women, the incidence of ovarian cancer is expected to increase year by year. Due to its lack of typical symptoms and effective screening methods, and the characteristics of implantation and distant metastasis, more than 70% of ovarian cancers were in the metastatic stage at the time of diagnosis. In this study, the investigators will collect large samples of tissue from patients with ovarian cancer, conduct multi-omics studies, and mapped the characteristic maps of the genome and transcriptome of patients with metastatic ovarian cancer, and explore the molecular mechanisms that can be used as new targets for the treatment of ovarian cancer. Besides, the investigators will design and establish a database of metastatic ovarian cancer, integrate multiple omics, imaging, pathology, and clinical information to study their potential relevance, and analyze the relationship between various omics, imaging, pathology, and prognosis, establish ovaries Cancer prediction model.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2026
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. female, =18 years old; 2. diagnosed as ovarian cancer by imaging and pathology; 3. did not receive any anti-tumor drug treatment before surgery in the gynecology clinical department of the Sun Yat Sen Memorial Hospital of Sun Yat-Sen University; 4. received ovarian cancer surgery and Follow-up treatment; 5. Patients voluntarily participate in the research of this subject, have good compliance, and can complete the enrollment by the requirements of the trial; 6. Sign informed consent and agree to the collection and use of their data. Exclusion Criteria: 1. Patients who have received other anti-tumor treatments or received tumor surgery before enrollment; 2. Patients with malignant tumors in other parts; 3. Patients with uncontrollable neurological, psychiatric, or mental disorders; 4. Poor compliance and inability to Cooperate and describe treatment responders.

Study Design


Locations

Country Name City State
China The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universit Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (8)

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

Deng K, Yang C, Tan Q, Song W, Lu M, Zhao W, Lou G, Li Z, Li K, Hou Y. Sites of distant metastases and overall survival in ovarian cancer: A study of 1481 patients. Gynecol Oncol. 2018 Sep;150(3):460-465. doi: 10.1016/j.ygyno.2018.06.022. Epub 2018 Jul 9. — View Citation

Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26. — View Citation

Lheureux S, Braunstein M, Oza AM. Epithelial ovarian cancer: Evolution of management in the era of precision medicine. CA Cancer J Clin. 2019 Jul;69(4):280-304. doi: 10.3322/caac.21559. Epub 2019 May 17. — View Citation

Piver MS. Treatment of ovarian cancer at the crossroads: 50 years after single-agent melphalan chemotherapy. Oncology (Williston Park). 2006 Sep;20(10):1156, 1158. No abstract available. — View Citation

Reid BM, Permuth JB, Sellers TA. Epidemiology of ovarian cancer: a review. Cancer Biol Med. 2017 Feb;14(1):9-32. doi: 10.20892/j.issn.2095-3941.2016.0084. — View Citation

Webb PM, Jordan SJ. Epidemiology of epithelial ovarian cancer. Best Pract Res Clin Obstet Gynaecol. 2017 May;41:3-14. doi: 10.1016/j.bpobgyn.2016.08.006. Epub 2016 Oct 3. — View Citation

Weidle UH, Birzele F, Kollmorgen G, Rueger R. Mechanisms and Targets Involved in Dissemination of Ovarian Cancer. Cancer Genomics Proteomics. 2016 11-12;13(6):407-423. doi: 10.21873/cgp.20004. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-Free-Survival The sample will be tested immediately after they are taken from patients and the statistical analysis will be taken through study completion, an average of 3 year
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