Cervical CancerEternityNCT06351228
Fertility-sparing in Early-stage Cervcial Cancer: The ETERNITY Project
An observational study of Cervical Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer. The primary aim is to report outcomes of those patients. Other aims included: 1. Evaluation about the effectiveness of different treatment modalities; 2. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Conization plus nodal evaluation
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2024to 31 Dec 2024
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with early stage cervical cancer undegoing uterine preserving surgery
Who may be able to join
- Histological confirmed cervical cancer
- FIGO Stage IA1-IB3
- Fertility-sparing (conization plus nodal dissection)
Who cannot join
- age less than 18 yrs
- age more than 50 yrs
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Lombardy, 20133
About this study
Official title: Outcomes of Early-stage Cervcial Cancer Patients Sheduled to Have Fertility-sparing Approach: The ETERNITY Project
The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer.
The primary aim is to report outcomes of those patients.
Other aims included:
- Evaluation about the effectiveness of different treatment modalities;
- Evaluation of outcomes according to different stages of disease;
- Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery
- Conditions
- Cervical Cancer
- Being tested
- Conization plus nodal evaluation
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conization plus nodal evaluationOther
Conization plus nodal evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
oncological outcomes
disease-free survival
Measured: 3-yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start30 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351228
- Sponsor's protocol ID
- 5720
- Acronym
- Eternity
- Status last verified
- Mar 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bogani G, Scambia G, Malzoni M, Casarin J, Vizzielli G, Amant F, Raspagliesi F; Investigators of the ETERNITY Project. Chemo-conization in Early-sTage cERvical caNcer >2 cm scheduled for fertilItY-sparing approach: an analysis of the ETERNITY project. Int J Gynecol Cancer. 2025 Apr;35(4):101643. doi: 10.1016/j.ijgc.2025.101643. Epub 2025 Jan 17.
PubMed 39955179
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early-stage Cervcial Cancer Patients Sheduled to Have Fertility-sparing Approach: The ETERNITY Project
- ClinicalTrials.gov ID
- NCT06351228
- Acronym / sponsor ID
- Eternity / 5720
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Apr 2024 (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.
The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer.
The primary aim is to report outcomes of those patients.
Other aims included:
- Evaluation about the effectiveness of different treatment modalities;
- Evaluation of outcomes according to different stages of disease;
- Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with early stage cervical cancer undegoing uterine preserving surgery
Key inclusion criteria (3 listed)
- Histological confirmed cervical cancer
- FIGO Stage IA1-IB3
- Fertility-sparing (conization plus nodal dissection)
Key exclusion criteria (2 listed)
- age less than 18 yrs
- age more than 50 yrs
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 |
|---|---|---|
| Conization plus nodal evaluationConization plus nodal evaluation | Other | – |
Primary outcome
oncological outcomes
Time frame: 3-yrs
disease-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 39955179Bogani G, Scambia G, Malzoni M, Casarin J, Vizzielli G, Amant F, Raspagliesi F; Investigators of the ETERNITY Project. Chemo-conization in Early-sTage cERvical caNcer >2 cm scheduled for fertilItY-sparing approach: an analysis of the ETERNITY project. Int J Gynecol Cancer. 2025 Apr;35(4):101643. doi: 10.1016/j.ijgc.2025.101643. Epub 2025 Jan 17.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 3 inclusion and 2 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oncological outcomes (time frame: 3-yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06351228, which also lists 1 linked publication.
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 8 Apr 2024.