An observational study in Endometrial Cancer, sponsored by National Cancer Institute, Naples. Recruiting at 19 sites in 16 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-10-13.
Sponsored by National Cancer Institute, Naples · Observational
Approximately one fourth of cases of endometrial cancer (EC) are diagnosed in premenopausal women, of whom approximately 40% wish to preserve their fertility. When arising in young women, EC usually presents with favorable prognostic features, as a focal, well differentiated endometrioid tumor, with minimal or absent myometrial invasion. This profile corresponds to the Type 1 EC, which correlates with the estrogen/progesterone receptor positive (ER+/PR+) pattern. On the other hand, these patients frequently present with clinical signs of a hyperestrogenism (chronic anovulation, infertility, obesity). Primary progestin therapy has been demonstrated to be effective in early well differentiated tumors and in poor operative candidates with response rates ranging from 58-100%.Currently, the therapeutic approach to an early stage EC consists of a staging laparotomy/laparoscopy, including a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO), peritoneal washings, and lymphadenectomy (pelvic and aortic), depending on the pathological risk profile pre- and intraoperatively determined. Therefore, the current standard of surgical approach is preclusive of fertility.
The worldwide experience and data on conservative management of EC are, however, still limited. Most of reports based on cases retrospectively collected, harboring potential methodological bias, using different treatments and drugs, and with insufficient follow-up.
Some systematic reviews have been published in the last decade, trying to summarize the literature data. Therapeutic results seem to be promising with a regression rate of approximately 75% and relapse occurring in 25-40% of cases, with anecdotical reports of deaths of disease (DOD). The fertility outcome was, however, not satisfying with about 30% pregnancy rate in patients attempting to conceive, and an overall low rate of assisted reproductive techniques (ART) despite the subfertile clinical profile.Therefore, there is a need for a prospective, multicentre cooperative project able to systematically collect data from consecutive patients treated according to defined (not necessarily identical) protocols, concerning the oncological, as well as, the obstetrical outcomes. Moreover, this project could represent the "template" in which a pretreatment fertility counseling, psychological support, and definitive surgery are routinely included according to shared criteria.
PURPOSE The goal of this research project is to learn more about the safety of conservatively treating EC and about subsequent fertility outcome.
PROJECT TYPE Observational (patient archive) - The project runs within the framework of Gynecologic Cancer InterGroup (GCIG), thus, participating Centres must belong to one of the qualified National groups.
PROJECT DESIGN Observational model: Cohort
TIME PERSPECTIVE Prospective
ENDPOINT CLASSIFICATION Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes
INTERVENTIONS Data collection
OUTCOME MEASURES Primary outcome measures
Secondary outcome measures
REQUIREMENTS FOR PATIENT REGISTRATION
TREATMENT Since this is a archive, treatment is not dictated by a protocol. However, treatment has to be administered according to a IRB-approved local protocol (except for the countries where conservative treatment can be given outside a IRB-approved study because considered as a standard procedure).
DURATION A first phase of three years is planned, eventually followed by further three years.
PUBLICATION POLICY Data generated are property of all investigators and will be object of publication after general agreement.
DATA TO BE COLLECTED
Patient enrollment and registration of data are made by appropriate eCRFs via the Clinical Trials Unit of National Cancer Institute of Naples (Study Data Center) website through the following steps:
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's planned enrollment of 100 is below the median of 179 across 321 observational studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Premenopausal women diagnosed with endometrial cancer (EC)
Exclusion Criteria:
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Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes
Proportion of complete regression
Time frame: 10 years
Duration of response
Time frame: 10 years
Frequency of relapse
Time frame: 10 years
Pattern of relapse
Time frame: 10 years
Frequency of metachronous ovarian cancer
Time frame: 10 years
Tumor-related deaths
Time frame: 10 years
Treatment related morbidity
Time frame: 10 years
Frequency of spontaneous pregnancies
Time frame: 10 years
Frequency of pregnancies after ART
Time frame: 10 years
Frequency of residual disease on definitive surgical specimens
Time frame: 10 years
Plan to share: Yes — Data generated are property of all investigators and will be object of publication after general agreement.
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National Cancer Institute, Naples