Clinical trial NCT06777147: Reproductive Health Outcomes in Young Patients with Ovarian Cancer After Surgical Treatment: a Retrospective Study
Official title: Reproductive Health Outcomes in Young Patients with Ovarian Cancer After Surgical Treatment: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reproductive age Women ( \>18yrs: 45yrs ) with Ovarian Cancers who had surgical intervention between 2020 : 2023

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.


Eligibility criteria: Inclusion Criteria:

1. Women in reproductive age 18-45 yrs
2. Localized ovarian cancer
3. Patients undergoing surgical intervention

Exclusion Criteria:

1- 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

Primary outcomes:
measure: Percentage of fertility rate of Reproductive age Women with Ovarian Cancer who underwent surgical intervention
timeFrame: From enrollment till the end of the study
Secondary outcomes:
measure: Morbidity and mortality
timeFrame: From enrollment till the end of the study
measure: Sexual health
timeFrame: From enrollment till the end of the study
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.