Early-stage Epithelial Ovarian CancerREMISSIONNCT06879730
Retrospective Evaluation of Minimally-Invasive Surgical Strategies in Ovarian Neoplasms (REMISSION Study)
An observational study of Early-stage Epithelial Ovarian Cancer, run by Jvan Casarin, MD PhD at 1 site in Italy.
Trial summary
This observational study aims to evaluate the outcomes of patients with early-stage epithelial ovarian cancer who are treated with minimally invasive surgery (such as laparoscopic or robotic surgery). Specifically, the study will look at: 1. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Early-stage Epithelial Ovarian Cancer
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2024to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The current study is a retrospective multicentric international observational study of data from patients with apparent early-stage epithelial ovarian cancer who underwent minimally-invasive or open surgery between January 2014 and December 2023.
Who may be able to join
- Patients with apparent early-stage epithelial ovarian cancer at preoperative evaluation
- Patients who underwent surgery between January 2014 and December 2023
- Patients who underwent open or minimally invasive surgical staging (Laparoscopic or Robotic-assisted approach) or restaging procedure
- Patients with final pathology report of Epithelial Ovarian Cancer
Who cannot join
- Patients who have not performed a complete surgical staging
- Patients who underwent neoadjuvant chemotherapy
- Patients with invasive synchronous tumor
- Patients with no informed consent
- Patients with ASA class score of 4 or 5
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Giudici, Medical Doctor contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale Filippo del Ponte
Varese, Varese, 21100
Jvan Casarin, MD, PhD, +39 0332299309, jcasarin@uninsubria.it
Anna Giudici, MD, agiudici6@uninsubria.it
About this study
This observational study aims to evaluate the outcomes of patients with early-stage epithelial ovarian cancer who are treated with minimally invasive surgery (such as laparoscopic or robotic surgery). Specifically, the study will look at:
- Post-Surgery Complications
Read more
- What is the rate of complications within 30 days after surgery?
- How often do patients require readmission to the hospital, re-operation, or conversion to open surgery?
- Cancer Outcomes
- What is the rate of cancer upstaging (when the cancer spreads to a more advanced stage during surgery for example because of an intra-operative ovarian cyst rupture)?
- What are the overall survival and disease-free survival rates for patients treated with minimally invasive surgery?
Researchers will compare two groups of patients:
Group 1: Patients with early-stage ovarian cancer treated with minimally invasive surgery.
Group 2: Patients with early-stage ovarian cancer treated with open surgery. The goal is to see if there are any differences in post-surgery complications, recovery, and cancer outcomes between the two groups.
Fertility-Sparing Treatment:
The study will also compare patients who are undergoing fertility-sparing treatments for early-stage ovarian cancer. Two subgroups will be looked at:
- Patients receiving fertility-sparing surgery through a minimally invasive procedure.
- Patients receiving fertility-sparing surgery through an open surgery. The same outcomes (complications, survival, etc.) will be assessed and compared between these two groups as well.
- Conditions
- Early-stage Epithelial Ovarian Cancer
- Keywords
- early-stage epithelial ovarian cancer, minimally invasive surgery
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with minimally invasive approach | Not described | |
| Patients treated with open surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the number of patients with 30-day post-operative complication in the two groups (minimally invasive surgery and open surgery)
Measured: From surgery to post-operative day 30
To assess the number of patients with 30-day post-operative hospital readmission in the two groups (minimally invasive surgery and open surgery)
Measured: From surgery to post-operative day 30
To assess the number of patients with 30-day post-operative reoperation in the two groups (minimally invasive surgery and open surgery)
Measured: From surgery to post-operative day 30
To assess the rate of upstaging in the two groups (minimally invasive surgery and open surgery)
Measured: At the time of surgery
To assess the rate of conversion in the minimally invasive surgery group
Measured: At the time of surgery
Secondary outcomes (1)
To analyze predictor of recurrence and oncological outcomes in terms of disease-free survival (DFS) and overall survival (OS) in the minimally invasive surgery and in the open surgery groups
Measured: From the date of surgery to the date of the last follow-up or the date of recurrence/death, whichever occurs first, assessed up to 300 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start15 May 2024
- Primary completionFeb 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Epithelial Ovarian 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jvan Casarin, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jvan Casarin, MD PhD, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879730
- Sponsor's protocol ID
- 55/2024
- Acronym
- REMISSION
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Minimally-Invasive Surgical Strategies in Ovarian Neoplasms (REMISSION Study)
- ClinicalTrials.gov ID
- NCT06879730
- Acronym / sponsor ID
- REMISSION / 55/2024
- Conditions
- Early-stage Epithelial Ovarian Cancer
- Keywords
- early-stage epithelial ovarian cancer, minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Jvan Casarin, MD PhDUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Mar 2025 (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.
This observational study aims to evaluate the outcomes of patients with early-stage epithelial ovarian cancer who are treated with minimally invasive surgery (such as laparoscopic or robotic surgery). Specifically, the study will look at:
- Post-Surgery Complications
- What is the rate of complications within 30 days after surgery?
- How often do patients require readmission to the hospital, re-operation, or conversion to open surgery?
- Cancer Outcomes
- What is the rate of cancer upstaging (when the cancer spreads to a more advanced stage during surgery for example because of an intra-operative ovarian cyst rupture)?
- What are the overall survival and disease-free survival rates for patients treated with minimally invasive surgery?
Researchers will compare two groups of patients:
Group 1: Patients with early-stage ovarian cancer treated with minimally invasive surgery.
Group 2: Patients with early-stage ovarian cancer treated with open surgery. The goal is to see if there are any differences in post-surgery complications, recovery, and cancer outcomes between the two groups.
Fertility-Sparing Treatment:
The study will also compare patients who are undergoing fertility-sparing treatments for early-stage ovarian cancer. Two subgroups will be looked at:
- Patients receiving fertility-sparing surgery through a minimally invasive procedure.
- Patients receiving fertility-sparing surgery through an open surgery. The same outcomes (complications, survival, etc.) will be assessed and compared between these two groups as well.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with minimally invasive approach | – | – |
| Patients treated with open surgery | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The current study is a retrospective multicentric international observational study of data from patients with apparent early-stage epithelial ovarian cancer who underwent minimally-invasive or open surgery between January 2014 and December 2023.
Key inclusion criteria (4 listed)
- Patients with apparent early-stage epithelial ovarian cancer at preoperative evaluation
- Patients who underwent surgery between January 2014 and December 2023
- Patients who underwent open or minimally invasive surgical staging (Laparoscopic or Robotic-assisted approach) or restaging procedure
- Patients with final pathology report of Epithelial Ovarian Cancer
Key exclusion criteria (5 listed)
- Patients who have not performed a complete surgical staging
- Patients who underwent neoadjuvant chemotherapy
- Patients with invasive synchronous tumor
- Patients with no informed consent
- Patients with ASA class score of 4 or 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the number of patients with 30-day post-operative complication in the two groups (minimally invasive surgery and open surgery)
Time frame: From surgery to post-operative day 30
To assess the number of patients with 30-day post-operative hospital readmission in the two groups (minimally invasive surgery and open surgery)
Time frame: From surgery to post-operative day 30
To assess the number of patients with 30-day post-operative reoperation in the two groups (minimally invasive surgery and open surgery)
Time frame: From surgery to post-operative day 30
To assess the rate of upstaging in the two groups (minimally invasive surgery and open surgery)
Time frame: At the time of surgery
To assess the rate of conversion in the minimally invasive surgery group
Time frame: At the time of surgery
1 secondary outcome
To analyze predictor of recurrence and oncological outcomes in terms of disease-free survival (DFS) and overall survival (OS) in the minimally invasive surgery and in the open surgery groups
Time frame: From the date of surgery to the date of the last follow-up or the date of recurrence/death, whichever occurs first, assessed up to 300 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- 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.
Anna Giudici, Medical Doctor contact
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 Early-stage Epithelial Ovarian Cancer, run by Jvan Casarin, MD PhD 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jvan Casarin, Medical Doctor (+39 3335384990, j.casarin@uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the number of patients with 30-day post-operative complication in the two groups (minimally invasive surgery and open surgery) (time frame: From surgery to post-operative day 30). The study lists 5 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 17 Mar 2025.