Actively Recruiting
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-10-29
974
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix
- FIGO 2018 stage IA2-IB1 with tumor size 2 cm or less
- Depth of infiltration 10 mm or less on conization specimen
- Depth of infiltration 50% or less on pre-conization MRI or expert ultrasound scan
- Age 18 years or older
You will not qualify if you...
- Neuroendocrine, clear cell, or serous carcinoma
- Depth of infiltration greater than 10 mm on conization specimen
- Depth of infiltration greater than 50% on pre-conization imaging
- Cervical tumor larger than 2 cm
- Diagnosis made on inadvertent hysterectomy
- Neoadjuvant chemotherapy prior to surgery
- Previous pelvic radiotherapy
- Pregnancy
- Contraindications to surgery
- Lymph nodes larger than 15 mm in short axis
- Fertility sparing treatment or desire
- Recurrent cervical cancer
- Time between cervical cancer diagnosis and hysterectomy more than 4 months if conization had tumor negative margins
- Time between cervical cancer diagnosis and hysterectomy more than 3 months if conization had invasive tumor positive margins
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Actively Recruiting
Research Team
N
Nicolò Bizzarri, MD
CONTACT
M
Matteo Pavone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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