UnknownPhase 3

Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

Brazil150 participantsStarted 2021-02-11

Plain-language summary

To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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.

Remission rate from primary therapy

Timeframe: 3 years

NCT IDNCT04756713

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

MARCIO BARCELLOS, MD