Endometrial CancerNCT04290299
Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
An observational study of Endometrial Cancer, run by National Cancer Institute, Naples at 19 sites in 16 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Data collection
- How many people
- 100 participants
- Where
- 19 sitesin 16 countries
- Study dates
- 15 Sep 2015to 8 Apr 2025
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal women diagnosed with endometrial cancer (EC)
Who may be able to join
- 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).
Who cannot join
- -
Trial locations and contacts
19 sites in 16 countries.
19 sites in 16 countries
Canada2 sites, 2 recruiting
- Recruiting
NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)
Ottawa
- Recruiting
PMHC (Princess Margaret Hospital Consortium)
Toronto
Germany2 sites, 2 recruiting
- Recruiting
AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom
Berlin
- Recruiting
NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie)
Berlin
Japan2 sites, 2 recruiting
- Recruiting
GOTIC - Gynecologic Oncology Trial and Investigation Consortium
Katō
- Recruiting
JGOG - Japanese Gynecologic Oncology Group
Tokyo
United States1 site, 1 recruiting
- Recruiting
Cooperative Ovarian Cancer Group (COGI)
Stanford, California
Australia1 site, 1 recruiting
- Recruiting
ANZGOG - Australia and New Zealand Gynecological Oncology Group
Sydney
Austria1 site, 1 recruiting
- Recruiting
AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie
Vienna
Belgium1 site, 1 recruiting
- Recruiting
EORTC - European Organization for Research and Treatment of Cancer
Brussels
China1 site, 1 recruiting
- Recruiting
SGOG (Shanghai Gynecologic Oncology Group)
Shanghai
Denmark1 site, 1 recruiting
- Recruiting
NSGO (Nordic Society of Gynecologic Oncology)
Copenhagen
France1 site, 1 recruiting
- Recruiting
GINECO - Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens
Paris
Ireland1 site, 1 recruiting
- Recruiting
ICORG - Ireland Cooperative Oncology Research Group
Dublin
Italy1 site, 1 recruiting
- Recruiting
MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies)
Naples
Stefano Greggi, MD, s.greggi@istitutotumori.na.it
Netherlands1 site, 1 recruiting
- Recruiting
DGOG - Dutch Gynecologic Oncology Group
Amsterdam
South Korea1 site, 1 recruiting
- Recruiting
KGOG - Korean Gynecologic Oncology Group
Seoul
Spain1 site, 1 recruiting
- Recruiting
GEICO - Grupo Espanol de Investigacion en Cancer de Ovario
Madrid
United Kingdom1 site, 1 recruiting
- Recruiting
SGCTG (Scottish Gynaecological Cancer Trials Group)
Edinburgh
About this study
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.
Read the 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:
- go to http://www.usc-intnapoli.net;
- select language;
- click "Ask for authorization" to create your personal account;
- fill and send the "authorization form";
- make a screenshot of the "authorization form" and send it to l.sparavigna@istitutotumori.na.it;
- enter into to the system using your credentials and click on "E.C.Co.";
- click "the join request form";
- wait for authorization (a verification message will be sent to your email address within 24-48 h);
- enter into to the system using your credentials and click on "E.C.Co." for patient registration and/or updating.
- Conditions
- Endometrial Cancer
- Being tested
- Data collection
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of complete regression
Measured: 10 years
Duration of response
Measured: 10 years
Frequency of relapse
Measured: 10 years
Pattern of relapse
Measured: 10 years
Frequency of metachronous ovarian cancer
Measured: 10 years
Tumor-related deaths
Measured: 10 years
Secondary outcomes (4)
Treatment related morbidity
Measured: 10 years
Frequency of spontaneous pregnancies
Measured: 10 years
Frequency of pregnancies after ART
Measured: 10 years
Frequency of residual disease on definitive surgical specimens
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start15 Sep 2015
- Primary completion1 Feb 2025 (estimated)
- Study completion8 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Greggi, MD, Principal investigator, National Cancer Institute of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290299
- Sponsor's protocol ID
- 13/15 oss
- Status last verified
- Oct 2021
- First submitted
- 27 Feb 2020
- Last updated
- 13 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated are property of all investigators and will be object of publication after general agreement.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
- ClinicalTrials.gov ID
- NCT04290299
- Acronym / sponsor ID
- 13/15 oss
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 8 Apr 2025 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- go to http://www.usc-intnapoli.net;
- select language;
- click "Ask for authorization" to create your personal account;
- fill and send the "authorization form";
- make a screenshot of the "authorization form" and send it to l.sparavigna@istitutotumori.na.it;
- enter into to the system using your credentials and click on "E.C.Co.";
- click "the join request form";
- wait for authorization (a verification message will be sent to your email address within 24-48 h);
- enter into to the system using your credentials and click on "E.C.Co." for patient registration and/or updating.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal women diagnosed with endometrial cancer (EC)
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionCancer (response, relapse) and fertility (pregnancy, delivery) outcomes | Other | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Individual participant dataSharing planned: Yes. Data generated are property of all investigators and will be object of publication after general agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Greggi, MD principal investigator
National Cancer Institute of Naples
19 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by National Cancer Institute, Naples at 19 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada, Germany, Japan, United States, Australia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Greggi, MD (+39.081.5903417, s.greggi@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of complete regression (time frame: 10 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.