Status:
UNKNOWN
Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Maternidade Escola da Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
Conditions:
Gestational Trophoblastic Neoplasia
Molar Pregnancy
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.
Detailed Description
This is a randomized, multicenter clinical trial including patients seen at one of 13 gestational trophoblastic disease reference centers in Brazil. Subjects are eligible if they have low-risk gestati...
Eligibility Criteria
Inclusion
- Histopathological diagnosis of molar pegnancy according to the morphological criteria described by Sebire et al., who meet the diagnostic criteria for low-risk non-metastatic GTN according to FIGO 2000 criteria
Exclusion
- High risk GTN (FIGO risk score ≥ 7) or metastatic disease at diagnosis of GTN (stage II, III or IV);
- Histopathological diagnosis of choriocarcinoma, placental site trophoblastic or epithelioid trophoblastic tumor at the second curettage;
- Previous chemotherapy treatment;
- Level of hCG at the time of GTN diagnosis less than 20 IU/L (to minimize the risk of inclusion of patients with false positive hCG, either by cross-reaction with pituitary hormones or by the presence of circulating heterophilic antibodies);
- Relapsed GTN;
- Incomplete medical records.
- Loss to follow-up;
- Voluntary desire to stop participating in the study.
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04756713
Start Date
February 11 2021
End Date
December 31 2025
Last Update
May 27 2022
Active Locations (7)
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1
Paulista State University UNESP
Botucatu, Brazil
2
Campinas State University UNICAMP
Campinas, Brazil
3
University of Caxias do Sul
Caxias do Sul, Brazil
4
Federal University of Ceará
Ceará, Brazil