Status:
COMPLETED
Oncological Outcome After Completing or Abandoning (Radical) Hysterectomy in Patients With Cervical Cancer and Intraoperative Detection of LN Positivity
Lead Sponsor:
General University Hospital, Prague
Conditions:
Uterine Cervical Neoplasms
Eligibility:
FEMALE
18+ years
Brief Summary
The ABRAX trial is multicentre retrospective cohort study. Included are patients with negative LN in clinical staging, in whom LN involvement is detected intraoperatively. Completion or abandonment of...
Detailed Description
The management of patients with intraoperative detection of lymph node (LN) involvement currently varies widely. Options include completing or abandoning radical hysterectomy, performing or abandoning...
Eligibility Criteria
Inclusion
- Histologically confirmed squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
- Stage pT1a - pT2b
- Patient referred for primary surgical treatment such as radical / simple hysterectomy or fertility-sparing procedure (FST) and LN staging
- Intraoperative detection of LN involvement (any type of metastasis):
- Macroscopic involvement = grossly involved lymph nodes (if confirmed by final pathology) OR Microscopic involvement = SLN / LN intraoperative pathologic evaluation (frozen section)
- Follow-up data available for ≥ 2 years
- Surgery performed between January 2005 and December 2015
Exclusion
- Preoperative evidence of grossly involved LN
- Histologic subtypes other than those noted in the Inclusion criteria
- Negative pelvic LN
- LN involvement reported by the final histology but not detected during the surgery
- Unavailability of follow-up data
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT04037124
Start Date
December 1 2017
End Date
December 1 2020
Last Update
August 9 2022
Active Locations (1)
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1
Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Czech Republic
Prague, MUDr., Czechia, 12800