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Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04290299
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief Summary:

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.


Condition or disease Intervention/treatment
Endometrial Cancer Other: Data collection

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
Official Title: Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
Actual Study Start Date : September 15, 2015
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : April 8, 2025

Intervention Details:
  • Other: Data collection
    Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes


Primary Outcome Measures :
  1. Proportion of complete regression [ Time Frame: 10 years ]
  2. Duration of response [ Time Frame: 10 years ]
  3. Frequency of relapse [ Time Frame: 10 years ]
  4. Pattern of relapse [ Time Frame: 10 years ]
  5. Frequency of metachronous ovarian cancer [ Time Frame: 10 years ]
  6. Tumor-related deaths [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Treatment related morbidity [ Time Frame: 10 years ]
  2. Frequency of spontaneous pregnancies [ Time Frame: 10 years ]
  3. Frequency of pregnancies after ART [ Time Frame: 10 years ]
  4. Frequency of residual disease on definitive surgical specimens [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal women diagnosed with endometrial cancer (EC)
Criteria

Inclusion Criteria:

  • Informed consent to personal data processing
  • Existence of an IRB-approved local protocol that allows conservative treatment to be performed or statement that such treatment is considered as a standard (please note that such protocols should be shared with the database owner National Cancer Institute of Naples).

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290299


Contacts
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Contact: Stefano Greggi, MD +39.081.5903417 s.greggi@istitutotumori.na.it
Contact: Francesca Falcone, MD +39.081.5903417 francesca.falcone@istitutotumori.na.it

Locations
Show Show 19 study locations
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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Principal Investigator: Stefano Greggi, MD National Cancer Institute of Naples
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT04290299    
Other Study ID Numbers: 13/15 oss
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data generated are property of all investigators and will be object of publication after general agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female