NCT06777147

Brief Summary

Ovarian cancer (OC) is the second commonest gynecological cancer with an overall incidence of 1.4% , associated with high mortality rate , There are three major types of ovarian cancers: epithelial ovarian carcinomas, germ cell tumors, and stromal cell tumors . Ovarian cancer directly affects fertility, as treatment consists of surgical removal of the reproductive system and/or exposure to gonadotoxic agents. However, patients in early stages who meet established criteria can be treated with fertility-sparing surgeries and reach equivalent oncological results to those of traditional treatments. Fertility preservation techniques such as cryopreservation of oocytes, embryos and ovarian tissue may also be offered in some situations. Ovarian cancer (OC) has a high mortality rate and usually presents late in advanced stage, which poses challenges to management. Better understanding of the disease biology and application of radical surgery (RS) to achieve no visible residual tumor, alongside with chemotherapy, may lead to longer survival amongst these patients. Our purpose is to find out the fertility and survival rates of women with Overian Cancer in reproductive women who underwent surgical intervention. Radical Surgery for Overian cancer is one of the most challenging procedures in gynecologic oncology surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 15, 2025

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 22, 2024

Last Update Submit

January 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of fertility rate of Reproductive age Women with Ovarian Cancer who underwent surgical intervention

    From enrollment till the end of the study

Secondary Outcomes (2)

  • Morbidity and mortality

    From enrollment till the end of the study

  • Sexual health

    From enrollment till the end of the study

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Reproductive age Women ( \>18yrs: 45yrs ) with Ovarian Cancers who had surgical intervention between 2020 : 2023

You may qualify if:

  • Women in reproductive age 18-45 yrs
  • Localized ovarian cancer
  • Patients undergoing surgical intervention

You may not qualify if:

  • Patients who refuse to participate in the study. 2 - children and manupausl women 3 - Diffuse peritoneal ,enteric and mesenteric disease or very poor patient 's performance status 4 -Patients who were treated with chemotherapy only and not operated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Bhopal RS, Bansal N, Steiner M, Brewster DH; Scottish Health and Ethnicity Linkage Study. Does the 'Scottish effect' apply to all ethnic groups? All-cancer, lung, colorectal, breast and prostate cancer in the Scottish Health and Ethnicity Linkage Cohort Study. BMJ Open. 2012 Sep 25;2(5):e001957. doi: 10.1136/bmjopen-2012-001957. Print 2012.

    PMID: 23012329BACKGROUND
  • Derlatka P, Sienko J, Grabowska-Derlatka L, Palczewski P, Danska-Bidzinska A, Bidzinski M, Czajkowski K. Results of optimal debulking surgery with bowel resection in patients with advanced ovarian cancer. World J Surg Oncol. 2016 Feb 29;14:58. doi: 10.1186/s12957-016-0800-1.

    PMID: 26923029BACKGROUND
  • Chi DS, Eisenhauer EL, Lang J, Huh J, Haddad L, Abu-Rustum NR, Sonoda Y, Levine DA, Hensley M, Barakat RR. What is the optimal goal of primary cytoreductive surgery for bulky stage IIIC epithelial ovarian carcinoma (EOC)? Gynecol Oncol. 2006 Nov;103(2):559-64. doi: 10.1016/j.ygyno.2006.03.051. Epub 2006 May 22.

    PMID: 16714056BACKGROUND
  • van de Laar R, IntHout J, Van Gorp T, Verdonschot S, van Altena AM, Gerestein CG, Massuger LF, Zusterzeel PL, Kruitwagen RF. External validation of three prognostic models for overall survival in patients with advanced-stage epithelial ovarian cancer. Br J Cancer. 2014 Jan 7;110(1):42-8. doi: 10.1038/bjc.2013.717. Epub 2013 Nov 19.

    PMID: 24253502BACKGROUND
  • Patankar S, Burke WM, Hou JY, Tergas AI, Huang Y, Ananth CV, Neugut AI, Hershman DL, Wright JD. Risk stratification and outcomes of women undergoing surgery for ovarian cancer. Gynecol Oncol. 2015 Jul;138(1):62-9. doi: 10.1016/j.ygyno.2015.04.037. Epub 2015 May 11.

    PMID: 25976399BACKGROUND
  • Chiva L, Lapuente F, Castellanos T, Alonso S, Gonzalez-Martin A. What Should We Expect After a Complete Cytoreduction at the Time of Interval or Primary Debulking Surgery in Advanced Ovarian Cancer? Ann Surg Oncol. 2016 May;23(5):1666-73. doi: 10.1245/s10434-015-5051-9. Epub 2015 Dec 29.

    PMID: 26714955BACKGROUND
  • Rutten MJ, Boldingh JH, Schuit E, Trum H, van Driel W, Mol BW, Kenter GG, Buist MR. Development and internal validation of a prognostic model for survival after debulking surgery for epithelial ovarian cancer. Gynecol Oncol. 2014 Oct;135(1):13-8. doi: 10.1016/j.ygyno.2014.07.099. Epub 2014 Aug 2.

    PMID: 25093289BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Raed Abdeltawab Selim

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 15, 2025

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

January 15, 2025

Record last verified: 2024-12