BridgeMD
New treatment option for Cervical Cancer
Official title Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
ClinicalTrials.gov ID: NCT06416748
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
- Neoadjuvant chemotherapy
See the full eligibility criteria
- 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
- 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
- Neoadjuvant chemotherapy
- Previous pelvic radiotherapy
- Pregnant women
- Contraindications to surgery
- Lymph nodes \>15 mm short axis
- Fertility sparing treatment or desire
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.