NCT06416748Recruiting
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Source: ClinicalTrials.gov · Last updated 29 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.The SHAPE trial was designed to answer the clinical question of whether simple hysterectomy could be performed instead of radical hysterectomy in low-risk early stage cervical cancer but not the surgical approach. The favorable oncological outcome observed in SHAPE despite 75% of patients were treated with minimally invasive approach suggests that this approach may be safe. However, the trial was not designed to analyze oncological outcomes from surgical approach.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 974 (estimated)
- First submitted
- 11 May 2024
- Start date
- 27 Oct 2024
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Cervical cancer
- NCT number
- NCT06416748
What you commit to
- Study type: Interventional
- Planned participants: 974
- From 27 Oct 2024 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Neoadjuvant chemotherapy
- Previous pelvic radiotherapy
- Contraindications to surgery
Other illness
- Recurrent cervical cancer
- Time between cervical cancer diagnosis and hysterectomy \>4 months if conization with tumor negative margins
- Time between cervical cancer diagnosis and hysterectomy \>3 months if conization with invasive tumor positive margins
Other
- Neuroendocrine, clear cell, serous carcinoma
- Depth of infiltration \>10 mm on conization specimen
- Depth of infiltration \>50% at pre-conization imaging
- Cervical tumor \>2 cm
- Diagnosis on inadvertent hysterectomy
- Pregnant women
- Lymph nodes \>15 mm short axis
- Fertility sparing treatment or desire
Who the study is looking for
- Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma of uterine cervix
- FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤10mm on conization specimen
- FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤50% at pre-conization MRI-scan or "expert" US-scan.
- Age ≥18 years
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.