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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

Tracking Information
First Submitted Date February 27, 2020
First Posted Date February 28, 2020
Last Update Posted Date May 15, 2020
Actual Study Start Date September 15, 2015
Estimated Primary Completion Date February 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2020)
  • 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 ]
Original Primary Outcome Measures
 (submitted: February 27, 2020)
  • Proportion of complete regression [ Time Frame: 10 years ]
  • Duration of response [ Time Frame: 10 years ]
  • Frequency and pattern of relapse [ Time Frame: 10 years ]
  • Frequency of metachronous ovarian cancer [ Time Frame: 10 years ]
  • Tumor-related deaths [ Time Frame: 10 years ]
Change History
Current Secondary Outcome Measures
 (submitted: May 13, 2020)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: February 27, 2020)
  • Treatment related morbidity [ Time Frame: 10 years ]
  • Frequency of spontaneous pregnancies [ Time Frame: 10 years ]
  • Frequency of pregnancies after ART [ Time Frame: 10 years ]
  • Pattern of residual disease on definitive surgical specimens [ Time Frame: 10 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
Official Title Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
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.

Detailed Description

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

  • Proportion of complete regression
  • Duration of response
  • Frequency and pattern of relapse
  • Frequency of metachronous ovarian cancer
  • Tumor-related deaths

Secondary outcome measures

  • Treatment related morbidity
  • Frequency of spontaneous pregnancies
  • Frequency of pregnancies after ART
  • Pattern of residual disease on definitive surgical specimens

REQUIREMENTS FOR PATIENT REGISTRATION

  • 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).

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. go to http://www.usc-intnapoli.net;
  2. select language;
  3. click "Ask for authorization" to create your personal account;
  4. fill and send the "authorization form";
  5. make a screenshot of the "authorization form" and send it to l.sparavigna@istitutotumori.na.it;
  6. enter into to the system using your credentials and click on "E.C.Co.";
  7. click "the join request form";
  8. wait for authorization (a verification message will be sent to your email address within 24-48 h);
  9. enter into to the system using your credentials and click on "E.C.Co." for patient registration and/or updating.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Premenopausal women diagnosed with endometrial cancer (EC)
Condition Endometrial Cancer
Intervention Other: Data collection
Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 27, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 8, 2025
Estimated Primary Completion Date February 1, 2025   (Final data collection date for primary outcome measure)
Eligibility 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:

-

Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Stefano Greggi, MD +39.081.5903417 s.greggi@istitutotumori.na.it
Contact: Francesca Falcone, MD +39.081.5903417 francesca.falcone@istitutotumori.na.it
Listed Location Countries Australia,   Austria,   Belgium,   Canada,   China,   Denmark,   France,   Germany,   Ireland,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04290299
Other Study ID Numbers 13/15 oss
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party National Cancer Institute, Naples
Study Sponsor National Cancer Institute, Naples
Collaborators Not Provided
Investigators
Principal Investigator: Stefano Greggi, MD National Cancer Institute of Naples
PRS Account National Cancer Institute, Naples
Verification Date February 2020