Ovarian CancerNCT05251883
A Study to Analyze Data on Metastatic Ovarian Cancer Using Multi-omics
An observational study of Ovarian Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients with metastatic ovarian cancer from the gynecology clinical department of the Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Who may be able to join
- female, ≥18 years old;
- diagnosed as ovarian cancer by imaging and pathology;
- 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;
- received ovarian cancer surgery and Follow-up treatment;
- Patients voluntarily participate in the research of this subject, have good compliance, and can complete the enrollment by the requirements of the trial;
- Sign informed consent and agree to the collection and use of their data.
Who cannot join
- Patients who have received other anti-tumor treatments or received tumor surgery before enrollment;
- Patients with malignant tumors in other parts;
- Patients with uncontrollable neurological, psychiatric, or mental disorders;
- Poor compliance and inability to Cooperate and describe treatment responders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universit
Guangzhou, Guangdong
Huaiwu Lu, associate professor, +8618688395806, luhuaiwu@mail.sysu.edu.cn
About this study
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.
- Conditions
- Ovarian Cancer
- Keywords
- multi-omics, ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jan 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaiwu Lu, Study director, The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251883
- Sponsor's protocol ID
- SYSEC-KY-KS-2021-215
- Status last verified
- Sep 2022
- First submitted
- 9 Jan 2022
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27807064Bray 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.
PubMed 30207593Webb 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.
PubMed 27743768Ferlay 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.
PubMed 23485231Lheureux 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.
PubMed 31099893Deng 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.
PubMed 30001833Reid 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.
PubMed 28443200Piver 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.
PubMed 17024868
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Analyze Data on Metastatic Ovarian Cancer Using Multi-omics
- ClinicalTrials.gov ID
- NCT05251883
- Acronym / sponsor ID
- SYSEC-KY-KS-2021-215
- Conditions
- Ovarian Cancer
- Keywords
- multi-omics, ovarian cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with metastatic ovarian cancer from the gynecology clinical department of the Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Key inclusion criteria (6 listed)
- female, ≥18 years old;
- diagnosed as ovarian cancer by imaging and pathology;
- 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;
- received ovarian cancer surgery and Follow-up treatment;
- Patients voluntarily participate in the research of this subject, have good compliance, and can complete the enrollment by the requirements of the trial;
Key exclusion criteria (4 listed)
- Patients who have received other anti-tumor treatments or received tumor surgery before enrollment;
- Patients with malignant tumors in other parts;
- Patients with uncontrollable neurological, psychiatric, or mental disorders;
- Poor compliance and inability to Cooperate and describe treatment responders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free-Survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 27807064Weidle 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.
- Background: PubMed 30207593Bray 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.
- Background: PubMed 27743768Webb 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.
- Background: PubMed 23485231Ferlay 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.
- Background: PubMed 31099893Lheureux 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.
- Background: PubMed 30001833Deng 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.
- Background: PubMed 28443200Reid 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.
- Background: PubMed 17024868Piver 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huaiwu Lu study director
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaiwu Lu, Study Director (+86 18688395806, luhuaiwu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251883, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.