Ovarian CancerNCT06253559
Clinical and Pathological Characteristics of Women With Ovarian Cancers in Syria
An observational study of Ovarian Cancer, run by Latakia University at 1 site in Syria.
Trial summary
the goal of this observational study is to describe ovarian cancer epidemiology and characteristics in Syrian women, especially during the war to do more research in the future about the risk factors of ovarian cancer. 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
- 531 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2017to 24 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 women with ovarian cancer, with age ≥18 years,who have primary ovarian malignancy and underwent surgical or non-surgical treatment. the data recorded from records of the Departments of Gynecology and Oncology at Tishreen University Hospital in Latakia, Al-Bairouni University Hospital in Damascus, and Ibn Rushd Hospital in Aleppo, which are the 3 major hospitals in Syria that admit and treat patients with ovarian cancer.
Who may be able to join
- female adult (age ≥18 years)
- primary ovarian malignancy
Who cannot join
- less than 18 years old
- women who have benign tumors or metastatic ovarian cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Pathological Characteristics of Women With Ovarian Cancers, A National, Retrospective Cross-Sectional Study in Syria During the War
the goal of this observational study is to describe ovarian cancer epidemiology and characteristics in Syrian women, especially during the war to do more research in the future about the risk factors of ovarian cancer.
Read the detailed description
Ovarian cancer (OC) is the eighth most common cause of death worldwide, and current studies show that the death numbers caused by it will rise dramatically in the coming years. As the epidemiological features of the cancer may vary, studying these different characteristics can help us improve treatment outcomes and add preventive measures. In addition, giving special attention to these features in developing countries, or countries undergoing crisis, will help us understand the associated risk factors in these regions.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ovarian cancer patients | all ovarian cancer patients that meet the criteria of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
age
the age of patients at the time of diagnosis
Measured: jan 2017 - july 2021
ovarian cancer grade
ovarian cancer grades frequency among patients
Measured: jan 2017 - july 2021
histological type of ovarian cancer
detect the most common type of ovarian cancer
Measured: jan 2017 - july 2021
sideness of ovarian cancer
study the frequency of bilateral or unilateral ovarian cancer
Measured: jan 2017 - july 2021
Cancer Antigen-125
Cancer Antigen-125 levels, if they are normal or high in ovarian cancer.
Measured: jan 2017 - july 2021
Treatment
detect if the patient underwent surgery or chemotherapy or the both
Measured: jan 2017 - july 2021
symptoms of ovarian cancer
detect symptoms of disease at diagnosis time
Measured: jan 2017 - july 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Jan 2017
- Primary completion31 Jul 2021
- Study completion24 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Apelian, Principal investigator, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253559
- Sponsor's protocol ID
- TishreenU -Ovarian Cancer
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data can be shared upon your request
Publications
Zheng G, Yu H, Kanerva A, Forsti A, Sundquist K, Hemminki K. Familial risks of ovarian cancer by age at diagnosis, proband type and histology. PLoS One. 2018 Oct 3;13(10):e0205000. doi: 10.1371/journal.pone.0205000. eCollection 2018.
PubMed 30281663Wentzensen N, Poole EM, Trabert B, White E, Arslan AA, Patel AV, Setiawan VW, Visvanathan K, Weiderpass E, Adami HO, Black A, Bernstein L, Brinton LA, Buring J, Butler LM, Chamosa S, Clendenen TV, Dossus L, Fortner R, Gapstur SM, Gaudet MM, Gram IT, Hartge P, Hoffman-Bolton J, Idahl A, Jones M, Kaaks R, Kirsh V, Koh WP, Lacey JV Jr, Lee IM, Lundin E, Merritt MA, Onland-Moret NC, Peters U, Poynter JN, Rinaldi S, Robien K, Rohan T, Sandler DP, Schairer C, Schouten LJ, Sjoholm LK, Sieri S, Swerdlow A, Tjonneland A, Travis R, Trichopoulou A, van den Brandt PA, Wilkens L, Wolk A, Yang HP, Zeleniuch-Jacquotte A, Tworoger SS. Ovarian Cancer Risk Factors by Histologic Subtype: An Analysis From the Ovarian Cancer Cohort Consortium. J Clin Oncol. 2016 Aug 20;34(24):2888-98. doi: 10.1200/JCO.2016.66.8178. Epub 2016 Jun 20.
PubMed 27325851Yuan R, Zhang C, Li Q, Ji M, He N. The impact of marital status on stage at diagnosis and survival of female patients with breast and gynecologic cancers: A meta-analysis. Gynecol Oncol. 2021 Sep;162(3):778-787. doi: 10.1016/j.ygyno.2021.06.008. Epub 2021 Jun 16.
PubMed 34140180Torre LA, Trabert B, DeSantis CE, Miller KD, Samimi G, Runowicz CD, Gaudet MM, Jemal A, Siegel RL. Ovarian cancer statistics, 2018. CA Cancer J Clin. 2018 Jul;68(4):284-296. doi: 10.3322/caac.21456. Epub 2018 May 29.
PubMed 29809280Shanmughapriya, S., Senthilkumar, G., Arun, S., Das, B. C., & Natarajaseenivasan, K. (2016). Risk factors for epithelial ovarian carcinoma in India: A case control study in low-incidence population. International Journal of Cancer Research, 12(1), 61-68. https://doi.org/10.3923/IJCR.2016.61.68
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.
PubMed 28443200Prat J. Ovarian carcinomas: five distinct diseases with different origins, genetic alterations, and clinicopathological features. Virchows Arch. 2012 Mar;460(3):237-49. doi: 10.1007/s00428-012-1203-5. Epub 2012 Feb 10.
PubMed 22322322Parazzini F, Franceschi S, La Vecchia C, Fasoli M. The epidemiology of ovarian cancer. Gynecol Oncol. 1991 Oct;43(1):9-23. doi: 10.1016/0090-8258(91)90003-n.
PubMed 1959794Momenimovahed Z, Tiznobaik A, Taheri S, Salehiniya H. Ovarian cancer in the world: epidemiology and risk factors. Int J Womens Health. 2019 Apr 30;11:287-299. doi: 10.2147/IJWH.S197604. eCollection 2019.
PubMed 31118829Meena RK, Syed NA, Sheikh ZA, Guru FR, Mir MH, Banday SZ, Mp AK, Parveen S, Dar NA, Bhat GM. Patterns of Treatment and Outcomes in Epithelial Ovarian Cancer: A Retrospective North Indian Single-Institution Experience. JCO Glob Oncol. 2022 Nov;8:e2200032. doi: 10.1200/GO.22.00032.
PubMed 36332174McCluggage WG. Morphological subtypes of ovarian carcinoma: a review with emphasis on new developments and pathogenesis. Pathology. 2011 Aug;43(5):420-32. doi: 10.1097/PAT.0b013e328348a6e7.
PubMed 21716157Lukanova A, Kaaks R. Endogenous hormones and ovarian cancer: epidemiology and current hypotheses. Cancer Epidemiol Biomarkers Prev. 2005 Jan;14(1):98-107.
PubMed 15668482the World Cancer Research Fund (WCRF), worldwide cancer data., 2020; https://www.wcrf.org/cancer-trends/worldwide-cancer-data/ )
Lima MA, Dos Santos L, Turri JA, Nonogaki S, Buim M, Lima JF, de Jesus Viana Pinheiro J, Bueno de Toledo Osorio CA, Soares FA, Freitas VM. Prognostic Value of ADAMTS Proteases and Their Substrates in Epithelial Ovarian Cancer. Pathobiology. 2016;83(6):316-26. doi: 10.1159/000446244. Epub 2016 Jul 1.
PubMed 27359117Hayat MJ, Howlader N, Reichman ME, Edwards BK. Cancer statistics, trends, and multiple primary cancer analyses from the Surveillance, Epidemiology, and End Results (SEER) Program. Oncologist. 2007 Jan;12(1):20-37. doi: 10.1634/theoncologist.12-1-20.
PubMed 17227898
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Pathological Characteristics of Women With Ovarian Cancers, A National, Retrospective Cross-Sectional Study in Syria During the War
- ClinicalTrials.gov ID
- NCT06253559
- Acronym / sponsor ID
- TishreenU -Ovarian Cancer
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 24 Dec 2023 (actual)
- First posted
- 12 Feb 2024 (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.
the goal of this observational study is to describe ovarian cancer epidemiology and characteristics in Syrian women, especially during the war to do more research in the future about the risk factors of ovarian cancer.
Detailed description
Ovarian cancer (OC) is the eighth most common cause of death worldwide, and current studies show that the death numbers caused by it will rise dramatically in the coming years. As the epidemiological features of the cancer may vary, studying these different characteristics can help us improve treatment outcomes and add preventive measures. In addition, giving special attention to these features in developing countries, or countries undergoing crisis, will help us understand the associated risk factors in these regions.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ovarian cancer patients | – | –all ovarian cancer patients that meet the criteria of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all women with ovarian cancer, with age ≥18 years,who have primary ovarian malignancy and underwent surgical or non-surgical treatment. the data recorded from records of the Departments of Gynecology and Oncology at Tishreen University Hospital in Latakia, Al-Bairouni University Hospital in Damascus, and Ibn Rushd Hospital in Aleppo, which are the 3 major hospitals in Syria that admit and treat patients with ovarian cancer.
Key inclusion criteria (2 listed)
- female adult (age ≥18 years)
- primary ovarian malignancy
Key exclusion criteria (2 listed)
- less than 18 years old
- women who have benign tumors or metastatic ovarian cancer.
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
age
Time frame: jan 2017 - july 2021
the age of patients at the time of diagnosis
ovarian cancer grade
Time frame: jan 2017 - july 2021
ovarian cancer grades frequency among patients
histological type of ovarian cancer
Time frame: jan 2017 - july 2021
detect the most common type of ovarian cancer
sideness of ovarian cancer
Time frame: jan 2017 - july 2021
study the frequency of bilateral or unilateral ovarian cancer
Cancer Antigen-125
Time frame: jan 2017 - july 2021
Cancer Antigen-125 levels, if they are normal or high in ovarian cancer.
Treatment
Time frame: jan 2017 - july 2021
detect if the patient underwent surgery or chemotherapy or the both
symptoms of ovarian cancer
Time frame: jan 2017 - july 2021
detect symptoms of disease at diagnosis time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 30281663Zheng G, Yu H, Kanerva A, Forsti A, Sundquist K, Hemminki K. Familial risks of ovarian cancer by age at diagnosis, proband type and histology. PLoS One. 2018 Oct 3;13(10):e0205000. doi: 10.1371/journal.pone.0205000. eCollection 2018.
- Background: PubMed 27325851Wentzensen N, Poole EM, Trabert B, White E, Arslan AA, Patel AV, Setiawan VW, Visvanathan K, Weiderpass E, Adami HO, Black A, Bernstein L, Brinton LA, Buring J, Butler LM, Chamosa S, Clendenen TV, Dossus L, Fortner R, Gapstur SM, Gaudet MM, Gram IT, Hartge P, Hoffman-Bolton J, Idahl A, Jones M, Kaaks R, Kirsh V, Koh WP, Lacey JV Jr, Lee IM, Lundin E, Merritt MA, Onland-Moret NC, Peters U, Poynter JN, Rinaldi S, Robien K, Rohan T, Sandler DP, Schairer C, Schouten LJ, Sjoholm LK, Sieri S, Swerdlow A, Tjonneland A, Travis R, Trichopoulou A, van den Brandt PA, Wilkens L, Wolk A, Yang HP, Zeleniuch-Jacquotte A, Tworoger SS. Ovarian Cancer Risk Factors by Histologic Subtype: An Analysis From the Ovarian Cancer Cohort Consortium. J Clin Oncol. 2016 Aug 20;34(24):2888-98. doi: 10.1200/JCO.2016.66.8178. Epub 2016 Jun 20.
- Background: PubMed 34140180Yuan R, Zhang C, Li Q, Ji M, He N. The impact of marital status on stage at diagnosis and survival of female patients with breast and gynecologic cancers: A meta-analysis. Gynecol Oncol. 2021 Sep;162(3):778-787. doi: 10.1016/j.ygyno.2021.06.008. Epub 2021 Jun 16.
- Background: PubMed 29809280Torre LA, Trabert B, DeSantis CE, Miller KD, Samimi G, Runowicz CD, Gaudet MM, Jemal A, Siegel RL. Ovarian cancer statistics, 2018. CA Cancer J Clin. 2018 Jul;68(4):284-296. doi: 10.3322/caac.21456. Epub 2018 May 29.
- BackgroundShanmughapriya, S., Senthilkumar, G., Arun, S., Das, B. C., & Natarajaseenivasan, K. (2016). Risk factors for epithelial ovarian carcinoma in India: A case control study in low-incidence population. International Journal of Cancer Research, 12(1), 61-68. https://doi.org/10.3923/IJCR.2016.61.68
- 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 22322322Prat J. Ovarian carcinomas: five distinct diseases with different origins, genetic alterations, and clinicopathological features. Virchows Arch. 2012 Mar;460(3):237-49. doi: 10.1007/s00428-012-1203-5. Epub 2012 Feb 10.
- Background: PubMed 1959794Parazzini F, Franceschi S, La Vecchia C, Fasoli M. The epidemiology of ovarian cancer. Gynecol Oncol. 1991 Oct;43(1):9-23. doi: 10.1016/0090-8258(91)90003-n.
- Background: PubMed 31118829Momenimovahed Z, Tiznobaik A, Taheri S, Salehiniya H. Ovarian cancer in the world: epidemiology and risk factors. Int J Womens Health. 2019 Apr 30;11:287-299. doi: 10.2147/IJWH.S197604. eCollection 2019.
- Background: PubMed 36332174Meena RK, Syed NA, Sheikh ZA, Guru FR, Mir MH, Banday SZ, Mp AK, Parveen S, Dar NA, Bhat GM. Patterns of Treatment and Outcomes in Epithelial Ovarian Cancer: A Retrospective North Indian Single-Institution Experience. JCO Glob Oncol. 2022 Nov;8:e2200032. doi: 10.1200/GO.22.00032.
- Background: PubMed 21716157McCluggage WG. Morphological subtypes of ovarian carcinoma: a review with emphasis on new developments and pathogenesis. Pathology. 2011 Aug;43(5):420-32. doi: 10.1097/PAT.0b013e328348a6e7.
- Background: PubMed 15668482Lukanova A, Kaaks R. Endogenous hormones and ovarian cancer: epidemiology and current hypotheses. Cancer Epidemiol Biomarkers Prev. 2005 Jan;14(1):98-107.
- Individual participant dataSharing planned: Undecided. data can be shared upon your request
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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. This study is not recruiting at the moment.
Apelian principal investigator
Latakia 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 Latakia University at 1 site in Syria.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 Feb 2024. 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
age (time frame: jan 2017 - july 2021). The study lists 7 primary outcomes in all. 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 NCT06253559, which also lists 30 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 15 Feb 2024.